CS230858B1 - Method of defect indicating for medicinal rubber stoppers - Google Patents
Method of defect indicating for medicinal rubber stoppers Download PDFInfo
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- CS230858B1 CS230858B1 CS812808A CS280881A CS230858B1 CS 230858 B1 CS230858 B1 CS 230858B1 CS 812808 A CS812808 A CS 812808A CS 280881 A CS280881 A CS 280881A CS 230858 B1 CS230858 B1 CS 230858B1
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- 229920001971 elastomer Polymers 0.000 title claims abstract description 25
- 238000000034 method Methods 0.000 title claims description 15
- 230000007547 defect Effects 0.000 title 1
- 239000000243 solution Substances 0.000 claims abstract description 80
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 60
- 238000012360 testing method Methods 0.000 claims abstract description 40
- 239000008215 water for injection Substances 0.000 claims abstract description 17
- 229910052785 arsenic Inorganic materials 0.000 claims abstract description 8
- RQNWIZPPADIBDY-UHFFFAOYSA-N arsenic atom Chemical compound [As] RQNWIZPPADIBDY-UHFFFAOYSA-N 0.000 claims abstract description 8
- 150000003467 sulfuric acid derivatives Chemical class 0.000 claims abstract description 8
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 claims abstract description 7
- 238000010521 absorption reaction Methods 0.000 claims abstract description 7
- 239000000356 contaminant Substances 0.000 claims abstract description 7
- 238000001704 evaporation Methods 0.000 claims abstract description 7
- 230000008020 evaporation Effects 0.000 claims abstract description 7
- 229910001385 heavy metal Inorganic materials 0.000 claims abstract description 7
- 239000011701 zinc Substances 0.000 claims abstract description 7
- 229910052725 zinc Inorganic materials 0.000 claims abstract description 7
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims abstract description 6
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 claims abstract description 6
- 229910052788 barium Inorganic materials 0.000 claims abstract description 6
- DSAJWYNOEDNPEQ-UHFFFAOYSA-N barium atom Chemical compound [Ba] DSAJWYNOEDNPEQ-UHFFFAOYSA-N 0.000 claims abstract description 6
- 229910052791 calcium Inorganic materials 0.000 claims abstract description 6
- 239000011575 calcium Substances 0.000 claims abstract description 6
- 230000003595 spectral effect Effects 0.000 claims abstract description 6
- 229910052712 strontium Inorganic materials 0.000 claims abstract description 6
- CIOAGBVUUVVLOB-UHFFFAOYSA-N strontium atom Chemical compound [Sr] CIOAGBVUUVVLOB-UHFFFAOYSA-N 0.000 claims abstract description 6
- 239000010936 titanium Substances 0.000 claims abstract description 6
- 229910052719 titanium Inorganic materials 0.000 claims abstract description 6
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 claims abstract description 5
- 229910019142 PO4 Inorganic materials 0.000 claims abstract description 5
- 229910052782 aluminium Inorganic materials 0.000 claims abstract description 5
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims abstract description 5
- 150000003863 ammonium salts Chemical class 0.000 claims abstract description 5
- 239000012535 impurity Substances 0.000 claims abstract description 5
- 229910052749 magnesium Inorganic materials 0.000 claims abstract description 5
- 239000011777 magnesium Substances 0.000 claims abstract description 5
- 235000021317 phosphate Nutrition 0.000 claims abstract description 5
- 230000002797 proteolythic effect Effects 0.000 claims abstract description 5
- 150000004764 thiosulfuric acid derivatives Chemical class 0.000 claims abstract description 5
- 150000001412 amines Chemical class 0.000 claims abstract description 4
- 238000001816 cooling Methods 0.000 claims abstract description 3
- 235000012907 honey Nutrition 0.000 claims abstract description 3
- 150000003568 thioethers Chemical class 0.000 claims abstract 3
- 150000003841 chloride salts Chemical class 0.000 claims abstract 2
- 239000000126 substance Substances 0.000 claims description 8
- 239000002253 acid Substances 0.000 claims description 4
- 150000001642 boronic acid derivatives Chemical class 0.000 claims description 3
- -1 iron , phosphates Chemical class 0.000 claims description 3
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 abstract description 11
- 229910052742 iron Inorganic materials 0.000 abstract description 6
- 239000003638 chemical reducing agent Substances 0.000 abstract description 4
- 150000003013 phosphoric acid derivatives Chemical class 0.000 abstract description 4
- 125000005621 boronate group Chemical class 0.000 abstract 1
- 239000012085 test solution Substances 0.000 description 32
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 description 27
- 239000012088 reference solution Substances 0.000 description 19
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 15
- MUBZPKHOEPUJKR-UHFFFAOYSA-N Oxalic acid Chemical compound OC(=O)C(O)=O MUBZPKHOEPUJKR-UHFFFAOYSA-N 0.000 description 11
- 239000012286 potassium permanganate Substances 0.000 description 11
- 239000000523 sample Substances 0.000 description 10
- NLXLAEXVIDQMFP-UHFFFAOYSA-N Ammonium chloride Substances [NH4+].[Cl-] NLXLAEXVIDQMFP-UHFFFAOYSA-N 0.000 description 8
- JUJWROOIHBZHMG-UHFFFAOYSA-N Pyridine Chemical compound C1=CC=NC=C1 JUJWROOIHBZHMG-UHFFFAOYSA-N 0.000 description 8
- 239000000203 mixture Substances 0.000 description 8
- 239000013074 reference sample Substances 0.000 description 8
- 150000004763 sulfides Chemical class 0.000 description 8
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 7
- 238000002360 preparation method Methods 0.000 description 7
- SQGYOTSLMSWVJD-UHFFFAOYSA-N silver(1+) nitrate Chemical compound [Ag+].[O-]N(=O)=O SQGYOTSLMSWVJD-UHFFFAOYSA-N 0.000 description 7
- 150000001805 chlorine compounds Chemical class 0.000 description 6
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 6
- NLKNQRATVPKPDG-UHFFFAOYSA-M potassium iodide Chemical compound [K+].[I-] NLKNQRATVPKPDG-UHFFFAOYSA-M 0.000 description 6
- 238000010998 test method Methods 0.000 description 6
- VZGDMQKNWNREIO-UHFFFAOYSA-N tetrachloromethane Chemical compound ClC(Cl)(Cl)Cl VZGDMQKNWNREIO-UHFFFAOYSA-N 0.000 description 6
- 239000011521 glass Substances 0.000 description 5
- 238000005406 washing Methods 0.000 description 5
- VHUUQVKOLVNVRT-UHFFFAOYSA-N Ammonium hydroxide Chemical compound [NH4+].[OH-] VHUUQVKOLVNVRT-UHFFFAOYSA-N 0.000 description 4
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 4
- 235000011114 ammonium hydroxide Nutrition 0.000 description 4
- 238000006243 chemical reaction Methods 0.000 description 4
- 238000013098 chemical test method Methods 0.000 description 4
- 238000010411 cooking Methods 0.000 description 4
- 239000012153 distilled water Substances 0.000 description 4
- 238000001802 infusion Methods 0.000 description 4
- 238000012544 monitoring process Methods 0.000 description 4
- UMJSCPRVCHMLSP-UHFFFAOYSA-N pyridine Natural products COC1=CC=CN=C1 UMJSCPRVCHMLSP-UHFFFAOYSA-N 0.000 description 4
- 239000011734 sodium Substances 0.000 description 4
- 230000001954 sterilising effect Effects 0.000 description 4
- 238000004659 sterilization and disinfection Methods 0.000 description 4
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 3
- BVKZGUZCCUSVTD-UHFFFAOYSA-L Carbonate Chemical compound [O-]C([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-L 0.000 description 3
- RWSOTUBLDIXVET-UHFFFAOYSA-N Dihydrogen sulfide Chemical compound S RWSOTUBLDIXVET-UHFFFAOYSA-N 0.000 description 3
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 3
- BQCADISMDOOEFD-UHFFFAOYSA-N Silver Chemical compound [Ag] BQCADISMDOOEFD-UHFFFAOYSA-N 0.000 description 3
- APUPEJJSWDHEBO-UHFFFAOYSA-P ammonium molybdate Chemical compound [NH4+].[NH4+].[O-][Mo]([O-])(=O)=O APUPEJJSWDHEBO-UHFFFAOYSA-P 0.000 description 3
- 239000011609 ammonium molybdate Substances 0.000 description 3
- 235000018660 ammonium molybdate Nutrition 0.000 description 3
- 229940010552 ammonium molybdate Drugs 0.000 description 3
- 235000006408 oxalic acid Nutrition 0.000 description 3
- 229910052709 silver Inorganic materials 0.000 description 3
- 239000004332 silver Substances 0.000 description 3
- 229910052708 sodium Inorganic materials 0.000 description 3
- ZPLCXHWYPWVJDL-UHFFFAOYSA-N 4-[(4-hydroxyphenyl)methyl]-1,3-oxazolidin-2-one Chemical compound C1=CC(O)=CC=C1CC1NC(=O)OC1 ZPLCXHWYPWVJDL-UHFFFAOYSA-N 0.000 description 2
- QGZKDVFQNNGYKY-UHFFFAOYSA-O Ammonium Chemical compound [NH4+] QGZKDVFQNNGYKY-UHFFFAOYSA-O 0.000 description 2
- 235000003392 Curcuma domestica Nutrition 0.000 description 2
- 244000008991 Curcuma longa Species 0.000 description 2
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 description 2
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 description 2
- 239000004133 Sodium thiosulphate Substances 0.000 description 2
- ATJFFYVFTNAWJD-UHFFFAOYSA-N Tin Chemical compound [Sn] ATJFFYVFTNAWJD-UHFFFAOYSA-N 0.000 description 2
- 229910021626 Tin(II) chloride Inorganic materials 0.000 description 2
- 238000002835 absorbance Methods 0.000 description 2
- 235000019270 ammonium chloride Nutrition 0.000 description 2
- VBIXEXWLHSRNKB-UHFFFAOYSA-N ammonium oxalate Chemical compound [NH4+].[NH4+].[O-]C(=O)C([O-])=O VBIXEXWLHSRNKB-UHFFFAOYSA-N 0.000 description 2
- 238000003556 assay Methods 0.000 description 2
- 230000033228 biological regulation Effects 0.000 description 2
- 238000009835 boiling Methods 0.000 description 2
- 239000003153 chemical reaction reagent Substances 0.000 description 2
- 239000013078 crystal Substances 0.000 description 2
- 235000003373 curcuma longa Nutrition 0.000 description 2
- 238000005238 degreasing Methods 0.000 description 2
- 239000013527 degreasing agent Substances 0.000 description 2
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 description 2
- 229910000397 disodium phosphate Inorganic materials 0.000 description 2
- 235000019800 disodium phosphate Nutrition 0.000 description 2
- 238000010438 heat treatment Methods 0.000 description 2
- 229910052739 hydrogen Inorganic materials 0.000 description 2
- 239000001257 hydrogen Substances 0.000 description 2
- GPRLSGONYQIRFK-UHFFFAOYSA-N hydron Chemical compound [H+] GPRLSGONYQIRFK-UHFFFAOYSA-N 0.000 description 2
- 239000003978 infusion fluid Substances 0.000 description 2
- 238000002347 injection Methods 0.000 description 2
- 239000007924 injection Substances 0.000 description 2
- 150000002500 ions Chemical class 0.000 description 2
- NUJOXMJBOLGQSY-UHFFFAOYSA-N manganese dioxide Chemical compound O=[Mn]=O NUJOXMJBOLGQSY-UHFFFAOYSA-N 0.000 description 2
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 description 2
- 239000011591 potassium Substances 0.000 description 2
- 229910052700 potassium Inorganic materials 0.000 description 2
- IOLCXVTUBQKXJR-UHFFFAOYSA-M potassium bromide Chemical compound [K+].[Br-] IOLCXVTUBQKXJR-UHFFFAOYSA-M 0.000 description 2
- 229910001961 silver nitrate Inorganic materials 0.000 description 2
- 239000011780 sodium chloride Substances 0.000 description 2
- GRVFOGOEDUUMBP-UHFFFAOYSA-N sodium sulfide (anhydrous) Chemical compound [Na+].[Na+].[S-2] GRVFOGOEDUUMBP-UHFFFAOYSA-N 0.000 description 2
- AKHNMLFCWUSKQB-UHFFFAOYSA-L sodium thiosulfate Chemical compound [Na+].[Na+].[O-]S([O-])(=O)=S AKHNMLFCWUSKQB-UHFFFAOYSA-L 0.000 description 2
- 235000019345 sodium thiosulphate Nutrition 0.000 description 2
- 239000012086 standard solution Substances 0.000 description 2
- 235000011150 stannous chloride Nutrition 0.000 description 2
- 229910052718 tin Inorganic materials 0.000 description 2
- YWYZEGXAUVWDED-UHFFFAOYSA-N triammonium citrate Chemical compound [NH4+].[NH4+].[NH4+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O YWYZEGXAUVWDED-UHFFFAOYSA-N 0.000 description 2
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 description 2
- 235000013976 turmeric Nutrition 0.000 description 2
- TXUICONDJPYNPY-UHFFFAOYSA-N (1,10,13-trimethyl-3-oxo-4,5,6,7,8,9,11,12,14,15,16,17-dodecahydrocyclopenta[a]phenanthren-17-yl) heptanoate Chemical compound C1CC2CC(=O)C=C(C)C2(C)C2C1C1CCC(OC(=O)CCCCCC)C1(C)CC2 TXUICONDJPYNPY-UHFFFAOYSA-N 0.000 description 1
- ZXSQEZNORDWBGZ-UHFFFAOYSA-N 1,3-dihydropyrrolo[2,3-b]pyridin-2-one Chemical compound C1=CN=C2NC(=O)CC2=C1 ZXSQEZNORDWBGZ-UHFFFAOYSA-N 0.000 description 1
- ZCYVEMRRCGMTRW-UHFFFAOYSA-N 7553-56-2 Chemical compound [I] ZCYVEMRRCGMTRW-UHFFFAOYSA-N 0.000 description 1
- USFZMSVCRYTOJT-UHFFFAOYSA-N Ammonium acetate Chemical compound N.CC(O)=O USFZMSVCRYTOJT-UHFFFAOYSA-N 0.000 description 1
- 239000005695 Ammonium acetate Substances 0.000 description 1
- BTBUEUYNUDRHOZ-UHFFFAOYSA-N Borate Chemical compound [O-]B([O-])[O-] BTBUEUYNUDRHOZ-UHFFFAOYSA-N 0.000 description 1
- QDHHCQZDFGDHMP-UHFFFAOYSA-N Chloramine Chemical compound ClN QDHHCQZDFGDHMP-UHFFFAOYSA-N 0.000 description 1
- 229920000742 Cotton Polymers 0.000 description 1
- MHAJPDPJQMAIIY-UHFFFAOYSA-N Hydrogen peroxide Chemical compound OO MHAJPDPJQMAIIY-UHFFFAOYSA-N 0.000 description 1
- 239000004159 Potassium persulphate Substances 0.000 description 1
- 229920002472 Starch Polymers 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 230000032683 aging Effects 0.000 description 1
- XKMRRTOUMJRJIA-UHFFFAOYSA-N ammonia nh3 Chemical compound N.N XKMRRTOUMJRJIA-UHFFFAOYSA-N 0.000 description 1
- 229940043376 ammonium acetate Drugs 0.000 description 1
- 235000019257 ammonium acetate Nutrition 0.000 description 1
- PRKQVKDSMLBJBJ-UHFFFAOYSA-N ammonium carbonate Chemical class N.N.OC(O)=O PRKQVKDSMLBJBJ-UHFFFAOYSA-N 0.000 description 1
- 229910052787 antimony Inorganic materials 0.000 description 1
- WATWJIUSRGPENY-UHFFFAOYSA-N antimony atom Chemical compound [Sb] WATWJIUSRGPENY-UHFFFAOYSA-N 0.000 description 1
- 150000001495 arsenic compounds Chemical class 0.000 description 1
- WDIHJSXYQDMJHN-UHFFFAOYSA-L barium chloride Chemical compound [Cl-].[Cl-].[Ba+2] WDIHJSXYQDMJHN-UHFFFAOYSA-L 0.000 description 1
- 229910001626 barium chloride Inorganic materials 0.000 description 1
- 239000012496 blank sample Substances 0.000 description 1
- 235000012206 bottled water Nutrition 0.000 description 1
- 159000000007 calcium salts Chemical class 0.000 description 1
- 229910052804 chromium Inorganic materials 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 238000012937 correction Methods 0.000 description 1
- 238000004132 cross linking Methods 0.000 description 1
- 239000003599 detergent Substances 0.000 description 1
- ZOMNIUBKTOKEHS-UHFFFAOYSA-L dimercury dichloride Chemical class Cl[Hg][Hg]Cl ZOMNIUBKTOKEHS-UHFFFAOYSA-L 0.000 description 1
- 238000002845 discoloration Methods 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 239000003651 drinking water Substances 0.000 description 1
- 239000000428 dust Substances 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000003344 environmental pollutant Substances 0.000 description 1
- 238000011049 filling Methods 0.000 description 1
- 239000000706 filtrate Substances 0.000 description 1
- 238000011010 flushing procedure Methods 0.000 description 1
- 238000013467 fragmentation Methods 0.000 description 1
- 238000006062 fragmentation reaction Methods 0.000 description 1
- 239000005337 ground glass Substances 0.000 description 1
- 229940093920 gynecological arsenic compound Drugs 0.000 description 1
- 229910000037 hydrogen sulfide Inorganic materials 0.000 description 1
- 239000008235 industrial water Substances 0.000 description 1
- 239000011630 iodine Substances 0.000 description 1
- 229910052740 iodine Inorganic materials 0.000 description 1
- 238000002386 leaching Methods 0.000 description 1
- 229940046892 lead acetate Drugs 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- QSHDDOUJBYECFT-UHFFFAOYSA-N mercury Chemical compound [Hg] QSHDDOUJBYECFT-UHFFFAOYSA-N 0.000 description 1
- 229910052753 mercury Inorganic materials 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 description 1
- CEQFOVLGLXCDCX-WUKNDPDISA-N methyl red Chemical compound C1=CC(N(C)C)=CC=C1\N=N\C1=CC=CC=C1C(O)=O CEQFOVLGLXCDCX-WUKNDPDISA-N 0.000 description 1
- 230000003472 neutralizing effect Effects 0.000 description 1
- 230000010494 opalescence Effects 0.000 description 1
- 238000001139 pH measurement Methods 0.000 description 1
- 230000020477 pH reduction Effects 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 229910052697 platinum Inorganic materials 0.000 description 1
- 231100000719 pollutant Toxicity 0.000 description 1
- 239000000276 potassium ferrocyanide Substances 0.000 description 1
- USHAGKDGDHPEEY-UHFFFAOYSA-L potassium persulfate Chemical compound [K+].[K+].[O-]S(=O)(=O)OOS([O-])(=O)=O USHAGKDGDHPEEY-UHFFFAOYSA-L 0.000 description 1
- 235000019394 potassium persulphate Nutrition 0.000 description 1
- 239000002244 precipitate Substances 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 238000000746 purification Methods 0.000 description 1
- 239000012266 salt solution Substances 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- LKZMBDSASOBTPN-UHFFFAOYSA-L silver carbonate Substances [Ag].[O-]C([O-])=O LKZMBDSASOBTPN-UHFFFAOYSA-L 0.000 description 1
- 229910001958 silver carbonate Inorganic materials 0.000 description 1
- 239000001488 sodium phosphate Substances 0.000 description 1
- 229910000162 sodium phosphate Inorganic materials 0.000 description 1
- 235000011008 sodium phosphates Nutrition 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 239000001119 stannous chloride Substances 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 235000011149 sulphuric acid Nutrition 0.000 description 1
- XOGGUFAVLNCTRS-UHFFFAOYSA-N tetrapotassium;iron(2+);hexacyanide Chemical compound [K+].[K+].[K+].[K+].[Fe+2].N#[C-].N#[C-].N#[C-].N#[C-].N#[C-].N#[C-] XOGGUFAVLNCTRS-UHFFFAOYSA-N 0.000 description 1
- 239000011135 tin Substances 0.000 description 1
- AXZWODMDQAVCJE-UHFFFAOYSA-L tin(II) chloride (anhydrous) Chemical compound [Cl-].[Cl-].[Sn+2] AXZWODMDQAVCJE-UHFFFAOYSA-L 0.000 description 1
- 229910000406 trisodium phosphate Inorganic materials 0.000 description 1
- 235000019801 trisodium phosphate Nutrition 0.000 description 1
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- Investigating Or Analyzing Non-Biological Materials By The Use Of Chemical Means (AREA)
Abstract
Vynález rieši stanovenie nezávadnosti gumových zátok v zdravotníctve vo vodě. Podstata vynálezu spočívá v tom, že sa zátky uvedú do styku s vodou po dobu 30 minút pri teplote 120 °C, pri tlaku 0,101 325 MPa a najmenej 24 hodin po vychladnutí sa stanoví vzhlad roztoku, vzhlad zátky, aktuál- na acidita, vodivost, arzén, barium, hořčík, med', ťažké kovy dvoma spfisobmi, vápník, stroncium, soli amónne, aminy, chloridy, sírany, sírniky, thiosírany, zbytky po odpaření, vyznačujúci sa tým, že tieto skúšky sa vykonajú vo vodě apyrogennej, vo vodě na injekciu a že sa ďalej skúšajú proteolytické příměsi, cudzie organické znečisteňiny meraním spektrálnej absorpčnej křivky vo vlnovom rozsahu 220 až 360 nm, dokážu sa borl- tany, hliník, titan, zinok, železo, fosforečnany, ďalej sa vyznačujú tým, že sa navýše stanovin organické a iné redukujúce látky.The invention addresses the determination of the safety of rubber stoppers in health care in water. The invention is based on the fact that the stoppers are contacted with water for 30 minutes at 120 ° C, at a pressure of 0.101 325 MPa and the appearance of the solution, appearance of the plug, current acidity, conductivity is determined for at least 24 hours after cooling. arsenic, barium, magnesium, honey, heavy metals, two, calcium, strontium, ammonium salts, amines, chlorides, sulphates, sulphides, thiosulphates, evaporation residues, characterized in that these tests are carried out in water and pyrogen-free, in water for injection, and for proteolytic impurities to be tested, foreign organic contaminants by measuring spectral absorption curves in the wavelength range of 220 to 360 nm, boronates, aluminum, titanium, zinc, iron, phosphates are further characterized by organic and other reducing agents.
Description
Vynález rieši sposob stanovenia nezávadnosti gumových zátok v zdravotníctve v apyrbgennéj vodě na injekční. ·’SUMMARY OF THE INVENTION The present invention provides a method for the determination of the safety of rubber plugs in health care in apyrobic water for injection. · '
Sposob skúšania gumových zátok pozostáva doteraz z chemického skúšania vodného výluhu v ktorom sa stanovuje-podiel rozpustný vo vodě, opalescencia, stanovenie redox čísla, stanovenie koncentrácie vodíkových iontov, změny, elektrickej vodivosti a skúšky na přítomnost zdravotně závadných iontov týchto prvkov olova, ortuti, médi, arzénu, antimonu, cínu, železa, vápnika, stroncia, baria, horčíka, amónia, chloridov, sírnikov, kyslých sírnikov, síranov, a thiosíranov. Keď sa skúška vyykonáva vo výluhu pripravenom, ako infúzny roztok, ;treba uviesť aj skúšky, ktoré požaduje oborová norma ON 83 0745 pre vodu na injekciu.Skúšajú sa ťažké kovy, sírany, chloridy, soli- vápenaté, soli amonné, organické a iné -redukujúce látky, koncentrácia vodíkových iontov, odparok, rovnako aj t. č. platný liekopis ČsL3.The method of testing rubber stoppers has so far consisted of chemical testing of a water leachate in which the water-soluble fraction, opalescence, redox number determination, hydrogen ion concentration determination, change, electrical conductivity and the presence of harmful ions of these lead, mercury, media , arsenic, antimony, tin, iron, calcium, strontium, barium, magnesium, ammonium, chlorides, sulfides, acid sulfides, sulfates, and thiosulfates. When the test is carried out in an extract solution prepared as a solution for infusion ; the tests required by the industry standard ON 83 0745 for water for injections must also be reported. Heavy metals, sulphates, chlorides, calcium salts, ammonium salts, organic and other reducing agents, hydrogen ion concentration, evaporation as well as t. no. valid pharmacopoeia CsL3.
V zahraničných liekopisoeh QAB9, Ph. Helv. VI., DAB7, 2AB DDR, Farm. Frang. VIIIe., Ph. Ital., BP73., Ph. Nord., DIN 58 367 Blatt 1, JUS a Comp. médie., skúšajú vodné výluhy, ktoré sú připravené vyluhováním vďčšieho množstva zátok, hmotnost, ktorých je u každého liekopisu iná, ako aj množstvo vyluhovadla, doba kontaktu s vyluhovadlom a doba sterilizácie je rozdielna. Skúšanie sa zameriava na stedovanie redukujúcich látok, meranie pH, tažkých kovov, prchajúcich sulfidov, zbytok po odpaření, soli amonné, chloridy, sírany a 2AB DDR aj DIN 58 367 Blatt 2 sledovanie spektra v oblasti 210—360 nm. Compendium medicamentorum požaduje u vodného výluhu skúšanie nerozpustných znečistenín, farby roztoku, zápach, chuť, reakcia roztoku, amonium a aminy, ionty ťažkých kovov, baria, zinku, chloridy, fosforečnany, sírany, sulfidy, organické znečisteniny meraním spektrálnej absorpčnej křivky 220—360 nm u všetkých plastov, redukujúce znečisteniny, zbytok po odpaření.In Foreign Pharmacopoeia QAB9, Ph. Helv. VI., DAB 7, 2AB DDR, Farm. Frang. VIII e., Ph. Ital., BP73., Ph. Nord., DIN 58 367 Blatt 1, JUS and Comp. media, test aqueous leaches which are prepared by leaching a larger number of bays, the weight of which varies for each pharmacopoeia, as well as the amount of leachate, the contact time with the leachate and the sterilization time is different. The testing focuses on the concentration of reducing substances, pH measurement, heavy metals, volatile sulphides, evaporation residue, ammonium salts, chlorides, sulphates and 2AB DDR as well as DIN 58 367 Blatt 2 spectrum monitoring in the 210–360 nm range. Compendium medicamentorum requires testing of insoluble contaminants, solution color, odor, taste, solution reaction, ammonium and amines, heavy metal ions, barium, zinc, chlorides, phosphates, sulfates, sulfides, organic contaminants by measuring the spectral absorption curve of 220-360 nm for all plastics, reducing pollutants, evaporation residue.
Příprava výluhu podfa ČSN 77 4010 pre Gumové zátky pre zdravotnictvo pre trojotvorové zátky požadujú přípravu výluhu vo formě hotového infúzneho roztoku. Voda na injekciu a sledované kritéria by malí byť zhodné, alebo totožné s požiadavkami monografie článku Voda na injekciu v platnom t. č. ČsL3., hlavně, ak sa sleduje výluh čerstvý. Tu sa střetáváme s velkými rozdielmi nielen v ČSN pre gumové zátky, ale aj v samom ČsL3. Je to u skúsok aktuálnej acidity, kde sa v CsL3 skúša pomocou indikátora a ČSN 62 1156. Zkoušení pryyže zdravotně nezávadné, merané elektrometricky. Vel'ké rozdiele sú aj v sposobe stanovenia organických, alebo iných redukujúcich látok, v ČSN označené, ako stanovenie redox čísla. V CsL3 sa střetáváme s velkými rozdielmi u skúšky na organické a iné redukujúce látky, nielen v kritériach, ale aj v sposobe vykonáváme skúšky:Preparation of the extract according to ČSN 77 4010 for Rubber stoppers for medical devices for three-hole plugs require preparation of the extract in the form of a ready-made infusion solution. Water for injection and the criteria to be followed should be identical to or identical to the requirements of the Water for Injection monograph in force t. no. ČsL3., Mainly when fresh leachate is monitored. Here we encounter big differences not only in CSN for rubber plugs, but also in CsL3 itself. This is the case of actual acidity tests, where CsL3 is tested by means of an indicator and ČSN 62 1156. Testing of rubber is harmless, measured electrometrically. There are also big differences in the method of determination of organic or other reducing substances, designated in the ČSN as redox number determination. In CsL3 we encounter big differences in the test for organic and other reducing substances, not only in the criteria but also in the way we perform the tests:
1. U vody destilovanej v bode bj pre vodu v infúznych ffašiach uzavretú gumovou zátkou je predpísaná skúška následovně: K 100 mililitrom sa přidá 8,0 ml roztoku kyseliny sírovéj (125 g/L), 10,0 ml roztoku manganistanu draselného c(l/5 KMnCUJ = 0,01 mol/L, vaří sa 10 minút. Potom sa přidá 10,0 ml roztoku kyseliny šťavelovej c(l/2 C2H2O4.1. For water distilled at point bj for water in infusion bottles closed with a rubber stopper, the test prescribed is as follows: To 100 milliliters add 8.0 ml of sulfuric acid solution (125 g / L), 10.0 ml of potassium permanganate solution c (1). (5 KMnCUJ = 0.01 mol / L, boiled for 10 minutes), then add 10.0 ml of oxalic acid solution c (1/2 C2H2O4).
. 2 H2O )=0,01 mol/L, premieša sa a ihned' sa titruje roztokom manganistanu draselného c(l/5 KMnOáJ = 0,01 mol/L, hodnotí sa spotřeba manganistanu draselného, povolená je spotřeba najviac 2,0 ml.. 2 H2O) = 0,01 mol / L, mix and titrate immediately with potassium permanganate solution c (1/5 KMnOaJ = 0,01 mol / L), assess the consumption of potassium permanganate, the maximum consumption being 2,0 ml.
2. U vody na injekciu je odkaz bod j) — — Destilovaná voda tj. požiadavky, že 100 mililitrov destilovanej vody okyselenej 2,0 mililitra zriedenej kyseliny sírovej a 1,0 ml roztoku manganistanu draselného c(l/5 KMnOáJ = 0,01 mol/L sa nesmie do 3 minút změnit.2. For water for injection, reference is (j) - - Distilled water ie. the requirement that 100 milliliters of distilled water acidified with 2,0 milliliters of dilute sulfuric acid and 1,0 milliliters of potassium permanganate solution (1/5 KMnOaJ = 0,01 mol / L) must not be changed within 3 minutes.
3. Oborová norma pre vodu na injekciu ON 85 0745 platnost od 1. 4.1964 předpisuje, že sa vaří 100 ml vzorky s 2,0 ml zriedeného roztoku kyseliny sírovej (500 g/L) a 0,3 ml roztoku manganistanu draselného (1 g/L), nesmie sa do 3 minút odfarbiť.3. The industry standard for water for injections ON 85 0745, valid from 1. 4.1964, prescribes that a 100 ml sample is boiled with 2.0 ml of dilute sulfuric acid (500 g / L) and 0.3 ml of potassium permanganate (1 g). / L) must not discolour within 3 minutes.
4. Československá štátna norma ČSN 62 1156 — Chemické zkoušení pryže zdravotně nezávadné předpisuje skúšanie 50 ml, alebo 20 ml výluhu (nesmie byť starší, ako 24 hodin) 10 ml roztoku kyseliny sírovej (400 g/ /LJ a 20,0 ml roztoku manganistanu draselného c (1/5 KMnCU) = 0,01 mol/L. Roztok sa zahrieva na vriacom vodnom kúpeli presne 10 minút. Potom sa přidá 20,0 ml roztoku kyseliny šťavelovej c(l/2 C2H2O4.2H2OJ = = 0,01 mol/L a titruje sa za tepla roztokom manganistanu draselného c(1/5 KM-nO4) — = 0,01 mol/L, do stálého růžového sfarbenia. Za rovnakých podmienok sa vykoná skúška na slepej vzorke.4. Czechoslovak state standard ČSN 62 1156 - Chemical testing of rubber harmlessly prescribes testing of 50 ml or 20 ml of leachate (must not be older than 24 hours) 10 ml of sulfuric acid solution (400 g / LJ and 20.0 ml of permanganate solution) Potassium c (1/5 KMnCU) = 0,01 mol / L. Heat the solution in a boiling water bath for exactly 10 minutes, then add 20,0 ml of oxalic acid solution c (1/2 C2H2O4.2H2OJ = = 0,01 mol / L and titrated warm with potassium permanganate solution c (1/5 KM-nO 4 ) = 0,01 mol / L, until a pink color is obtained, under the same conditions, carry out a blank test.
5. Compendium medicamentorum pre skúšanie elastov předpisuje skúšku nasledovným sposobom:5. The Compendium medicamentorum for testing elastics prescribes the test in the following manner:
K 20,0 ml skúšaného roztoku sa v 300ml Erlenmayerovej banke přidá 20,0 ml roztoku manganistanu draselného c(l/5 KMnO4) = = 0,01 mol/L a 1,0 ml roztoku kyseliny sírovej c(l/2 H2SO4) = 3 mol/L. Banka sa uzavrie a za opakovaného pretrepávania sa nechá stát vo vriacej vodě po dobu 15 minút. Po přidaní 0,10 .g jodidu draselného sa vylúčený jód titruje roztokom thiosíranu sodného c(Na2S2O3j =0,01 mol/1, ako náhle je roztok už len slabo žito sfarbený, pridajú sa 2,0 ml škrobového indikátora, dotitruje sa do odfarbenia. Za rovnakých podmienok sa vykoná skúška so slepou vzorkou. Rozdiel medzi spotřebami roztoku thiosíranu sodného c(Na2S2O3j = 0,01 mol/L sa slepý pokus a hlavný pokus móže byť maximálně 3,0 ml.To 20.0 ml of the test solution in a 300 ml Erlenmeyer flask add 20.0 ml of potassium permanganate solution c (1/5 KMnO4) = 0.01 mol / L and 1.0 ml of sulfuric acid c (1 / 2H 2). SO 4 ) = 3 mol / L. Close the flask and allow to stand in boiling water for 15 minutes with repeated shaking. After the addition of 0,10 g of potassium iodide, the precipitated iodine is titrated with sodium thiosulphate solution c (Na2S2O3j = 0,01 mol / l, as soon as the solution is only slightly rye-colored, 2.0 ml of starch indicator are added, titrated until discoloration The difference between the consumptions of sodium thiosulphate solution c (Na2S2O3j = 0,01 mol / L) shall be the blank and the main test shall be a maximum of 3,0 ml.
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Oprava stanovenia bola v sposobe varenia vo vodnom kúpeli tak, aby nádoba bola ponořená pod hladinou skúšanej tekutiny, ktorá je vo vodnom kúpeli. Upresnenie je aj v tom, že 300ml Erlenmayerova banka sa po normálnom umytí naplní 150 ml vody, pridajú sa 2,0 ml roztoku kyseliny sírovej c(l/2 H2SO4/=Q mol/L, 1,0 ml roztoku manganistanu draselného c(l/5 KMnOd) — 0,1 mol/L a zahrieva sa do varu. Ak na stěnách banky zostane zrazenina mangandioxidu nie je vhodná na sí-movenie. Po přečištění sa banka dokladné prepláchne vodou a použije sa k stanovením Rozdiele v skúšaní organických a redukujúcich látok sú hlavně v sposobe okyselenia, době a sposobe varenia, čo podlá Fahnricha — Chemické zkoušení průmyslových vod u Kublovej metody je velmi závažná podinienka. Varenie priamo na sieťke nezabezpečuje dostatočnú reprodukovateřnosť skúšky v tom, že banka s roztokom nemá vždy rovnaký priebeh zahrievanía, čo do času a teploty může ovplyvniť výsledky stanovenia.The correction of the assay was in the manner of cooking in a water bath so that the vessel was submerged below the level of the test liquid in the water bath. It is also stated that the 300 ml Erlenmeyer flask is filled with 150 ml of water after normal washing, 2.0 ml of sulfuric acid c (1/2 H2SO4 / = Q mol / L, 1.0 ml of potassium permanganate solution c) are added. 1/5 KMnOd) - 0,1 mol / L and heated to boil If the manganese dioxide precipitate remains unsuitable for cross-linking on the walls of the flask After purification, the flask is rinsed thoroughly with water and used to determine the difference in the organic and Reducing substances are mainly in acidification, cooking time and cooking, which according to Fahnrich - Chemical testing of industrial water in the Kublov method is a very serious condition. Cooking directly on the mesh does not ensure sufficient reproducibility of the test in that the solution flask does not always have the same heating process. it may affect the results of the assay in time and temperature.
Dostupné naše a zahraničná předpisy na skúšanie gumových zátok pre zdravotnické účely nezahrnuji! dostatočne kontrolu na všetky migrujúce látky, sledovanie, ktorých sa dá najlapšie uplatnit u vody na injekciu.Available our and foreign regulations for testing rubber plugs for medical purposes do not include! sufficient control for all migrating substances, the monitoring which is most easily applied to water for injection.
Podstata vynálezu spočívá v tom, že sa zátky uvedú do styku s vodou po dobu 30 minút pri teplote 120 °C pri tlaku 0,101 325 MPa a naimenej 24 hodin po vychladnutí sa použijú známe stanovenia látok vo vodě — stanovenie vzhíadu roztoku, vzhladu zátky, aktuálnej acidity, vodivosti, arzénu, baria, horčíka, médi, ťažkých kovov dvoma sposobmi, vápnika, stroncia, soií amonných, amínov, chloridov, síranov, sírnikov, kyslých sírnikov, thiosíranov, zbytku po odpaření, využije sa „voda na injekciu“ na účely stanovenia nezávadnosti gumových zátok, použije sa aj nové stanovenie — cudzie organické znečisteniny meraním spektrálnej absorpčnej křivky vo vlnovom rozsahu 220 až 360 nm, skúžajú sa proteolytické prímesy, dokážu sa boritany, hliník, titan, zinok, železo, fosforečnany a stanovia sa organické a iné redukujúce látky modifikovanou metodou.The principle of the invention consists in contacting the plugs with water for 30 minutes at a temperature of 120 ° C at a pressure of 0.101 325 MPa and measured 24 hours after cooling, known determinations of the substances in water - determination of the appearance of the solution, acidity, conductivity, arsenic, barium, magnesium, media, heavy metals in two ways, calcium, strontium, ammonium salts, amines, chlorides, sulphates, sulphides, acid sulphides, thiosulphates, evaporation residue, water for injection will be used for determination of the safety of rubber plugs, a new determination - foreign organic contaminants by measuring the spectral absorption curve in the wavelength range 220 to 360 nm, proteolytic impurities, borates, aluminum, titanium, zinc, iron, phosphates and organic and other reducing agents by a modified method.
Rozšířením sposobu stanovenia nezávadnosti gumových zátok v zdravotníctve v apyrogennej vodě na injekciu o skúšanie na proteolytické prímesy, organické znečisteniny meraním spektrálnej absorpčnej křivky v oblasti 220 až 360 nm, ionty boritanov, hliníka, titanu, železa, fosforečnanov sa stává me· ranie špecifickejšie, zamerané na sledovanie migrujúcich súčastí zo zátky a zároveň zabezpečí informáciu o kvalitě gumovej zátky. Příklad prevedeniaBy extending the method of determining the safety of rubber bays in the pyrogen-free water for injection by testing for proteolytic impurities, organic contaminants by measuring the spectral absorption curve at 220 to 360 nm, borate, aluminum, titanium, iron, phosphate ions becomes more specific, focused to monitor migrating components from the plug while providing information about the quality of the rubber plug. Execution example
Voda na injekciu sa připraví z apyrogennej vody vyhovujúcej požiadavkám platného liekopisu t. č. ČsL3 zaužívanou technológiou pře přípravu iníúznycli íliaš v množstve 400 mililitrov. Infúzne fíaše musia byť dobré umyté. Technológia umývania fliaš sa prispůsobí sposobu umývania fliaš v automatické] umývačke následovně: Ffaše sa namočia na 24 hodin v odmasťovacom roztoku fosforečnanu sodného Na3PO4 (30 g/L) a chloramínu BS (5 g/L] za účelom odmastenia a desinfekcie. Po tejto době sa ffaše dobré popreplachujú pod tekúcou vodou 1,5 minúty, potom sa oplachujú 1,5 minúty horúcou vodou 80 °C. Do vhodnej nádoby sa vložia umyté ffaše a naleje sa na ne neutralizačný roztok kyseliny citrónové] (20 g/L] na 10 minút, potom sa prepláchnu teplou vodou 1,5 minúty, studenou vodou 1,5 minúty a nakoniec apyrogennou vodou tak, aby na 1 ffašu bola spotřeba 100 ml vody. Po dokladnom umytí sa ffaše sterilizujú 120 minút pri teplote 180 °C horúcim vzduchom. V sterilizátore sa ffaše zakrývajú.Water for injection is prepared from pyrogen-free water meeting the requirements of the current Pharmacopoeia t. no. CsL3 technology used for the preparation of the infusion bottles in the amount of 400 ml. The infusion bottles must be well washed. The bottle washing technology is adapted to the method of bottle washing in an automatic dishwasher as follows: The bottles are soaked for 24 hours in a sodium phosphate degreasing solution Na3PO4 (30 g / L) and chloramine BS (5 g / L) for degreasing and disinfection. The bottles were rinsed well under running water for 1.5 minutes, then rinsed for 1.5 minutes with hot water at 80 [deg.] C. The washed bottles were placed in a suitable container and poured into neutralizing citric acid solution] (20 g / L] to 10 minutes, then rinsed with warm water for 1.5 minutes, cold water for 1.5 minutes and finally pyrogen-free water so that 100 ml of water is consumed per bottle, and after thorough washing, the bottles are sterilized for 120 minutes at 180 ° C with hot air. The bottles are covered in the sterilizer.
Technológia umývania zátok pozostáva z dvojnásobného preplachovania teplou vodou za účelom odstránenia prachových častíc a hrubých úlomkou. Namočia sa do saponátového odmasťovača Dubaryl (5 g/L), alebo iného pre tento účel vhodného odmasťovača, potom sa zátky dobré opláchnu pitnou vodou, naliatim na zátky sa prepláchnu 4X, destilovanou vodou 2X, naleje sa na ne destilovaná voda a varia sa 10 minút, voda sa zleje a ešte 3X sa zátky prepláchnu apyrogennou vodou, opat sa na zátky naleje apyrogenná voda a sterilizuje sa 30 minút. Apyrogenná voda sa zleje zo zátok. Takto sú zátky připravené na zátkovanie fliaš.The technology of washing the bays consists of double flushing with warm water to remove dust particles and coarse debris. They are soaked in a detergent degreaser Dubaryl (5 g / L) or other suitable degreaser, then the plugs are rinsed well with potable water, poured onto the plugs, rinsed 4X, distilled water 2X, poured distilled water and boiled 10 minutes, the water is decanted and the plugs are rinsed with pyrogen-free water 3X, the apyrogenic water is poured on the plugs and sterilized for 30 minutes. The pyrogen-free water is poured from the bays. In this way the stoppers are ready for bottle stopping.
Ffaše po naplnění a zazátkovaní sa sterilizujú pri 120 °C 30 minút dolu hrdlom. Súčasne za rovnakých podmienok sa připraví slepá vzorka, ako porovnávacia vzorka v skle.Bottles after filling and stoppering are sterilized at 120 ° C for 30 minutes down the throat. At the same time, under the same conditions, prepare a blank sample as the reference sample in the glass.
Po sterilizácii sa roztoky nechajú vychladnúť a po 24 hodinách sa vykonajú skúšky.After sterilization, the solutions are allowed to cool and tests are carried out after 24 hours.
Za rovnakých technologických podmienok sa může pripraviť aj roztok koncentrovaný tak, že sa sterilizujú 3 zátky ponořené do skúšanej vody pre injekciu v hmotnostnom pomere 8 g zátky na 100 ml vody pre injekciu. Súčasne sa připraví porovnávací roztok bez zátok, za rovnakých podmienok, ako so zátkami.Under the same technological conditions, a concentrated solution may also be prepared by sterilizing 3 stoppers immersed in the test water for injection at a ratio of 8 g of stopper per 100 ml of water for injection. At the same time, prepare a reference solution without stoppers, under the same conditions as with the stoppers.
Skúšanie vody na injekcle je následovně:Testing water for injcle is as follows:
1. Vzhfad roztoku — sleduje sa změna čirosti, farby, pachu a mechanických nečistót roztoku proti porovnávaciemu roztoku.1. Appearance of solution - monitor the change in clarity, color, odor and mechanical impurities of the solution against the reference solution.
2. Vzhfad zátky — sleduje sa změna zátky po sterilizácii, prepichovacia schopnost, fragmentácia, lepivost tesnosť po vpichu apod.2. The appearance of the stopper - the change of the stopper after sterilization, puncture ability, fragmentation, stickiness and tightness after injection are monitored.
3. Aktuálna acidita — Skúša sa podTa monografie článku Voda na injekciu v ČsL3 následovně:3. Actual Acidity - Tested according to the monograph of the article Water for Injection in Cs3 as follows:
K 10,0 ml skúšaného roztoku sa pridajú 2 kvapky roztoku metylčervene [0,10 g metyl*Add 2 drops of methyl red solution [0,10 g methyl *] to 10,0 ml of the test solution.
23Ú8S8 červem; sa rozpustí miernym zahriatim v 3,7 mililitra roztoku - hydroxidu sodného c(NaOH]=0,l niol/L, doplní sa vodou prostou COž na 200 ml]. Roztok sa smie sfarbiť žito, až červenooranžovo, nie viac, ako porovnávací tlmivý roztok o pH 5,2. Skúšaný roztok sa nesmie sfarbiť viac, ako porovnávacia slepá vzorka. K dalším 10,0 ml skúšaného roztoku sa přidá 5 kvapiek roztoku brómtymolovej modrej [0,10 g brómtymolovej modrej sa· rozpustí zahriatim v 1,6 ml roztoku hydroxidu sodného c(NaOHj = 0,1 mol/L, doplní sa do 200 ml vodou]. Roztok smie byť sfarbený žité, až modrozelené, nie však intenzivnejšie modro, ako porovnávací tlmivý roztok o pH 7,0. Skúšaný roztok sa nesmie sfarbiť viac, ako porovnávacia vzorka.23Ú8S8 worm; Dissolve gently in 3,7 ml of sodium hydroxide solution c (NaOH) = 0, 1 niol / L, make up to 200 ml with CO 2 -free water. The solution may be colored rye to red-orange, not more than the reference buffer. The pH of the solution to be examined must not be more than the color of the blank to be examined. To a further 10,0 ml of the test solution add 5 drops of bromothymol blue solution [0,10 g of bromothymol blue dissolve by heating in 1,6 ml. Sodium hydroxide solution c (NaOH = 0,1 mol / L, made up to 200 ml with water) The solution may be dyed rye to blue-green but not more intense blue than the reference buffer pH 7,0. color more than the reference sample.
4. Proteolytické primesy — skúša sa podlá Compendium medicamentorum následovně:4. Proteolytic additives - tested according to Compendium medicamentorum as follows:
K 20,0 ml skúšaného roztoku a rovnako aj k 20,0 mi porovná vacieho roztoku sa přidá 1,0 · ml roztoku chloridu sodného (10 g/L j. Roztok sa premieša a meria sa aktuálna acidita na vhodnom pH metri za použitia sklenenej a násytenéj kalomelovej elektrody. Sleduje sa rozdiel pH v skúšanej vzorke a porovnávacom roztoku,To 20.0 ml of the test solution and to 20.0 ml of the reference solution add 1.0 ml of sodium chloride solution (10 g / L). Mix and measure the current acidity at a suitable pH meter using a glass and the saturated calomel electrode. The pH difference between the test sample and the reference solution is monitored,
5. Vodivost — skúška převzatá z ČSN 62 1156 — Zkoušení pryže zdravotně nezávadné následovně:5. Conductivity - test taken from ČSN 62 1156 - Health testing of rubber as follows:
V skúšanej vzorke sa meria vodivost na vhodnom konduktometri. Nameraná hodnota v skúšanej vzorke nesmie byť vyššia, ako v porovnávacej vzorke.Conductivity is measured in a test sample using a suitable conductometer. The measured value in the test sample must not be higher than in the reference sample.
6. Cudzie organické znečisteniny — Meria sa spektrálná absorbancia vo vlnovom rozsahu 220--360 nm, meria sa po 10 nm.6. Foreign organic contaminants - The spectral absorbance is measured in the 220-360 nm wavelength range, measured in 10 nm increments.
Sleduje sa posun absorbancie proti porovnávacej vzorke.The absorbance shift against the reference sample is monitored.
7. Arzén — skúša sa podlá všeobecnej statě do ČsL4 následovně:7. Arsenic - is tested according to the general article to Cs4 as follows:
Do banky pristroja na stanovenie arzénu sa napipetuje 20 ml skúšanej vzorky, přidá sa 5 ml dýmavej kyseliny chlorovodíkovej, prostej arzénu, 2 ml roztoku jodidu draselného (15 g/L) a 0,5 ml roztoku chloridu cínatého. Zmes sa dokladné premieša a nechá sa stať 15 minút, aby sa zlúčeniny arzeničné, pokial' sú přítomné zredukovali na arzeničné. Medzitým sa do sklenenej trubičky, spájajúcej obe časti pristroja vloží vata napuštěná octanom olovnatým pre zachytenie sírovodíka a do absorpčnej skúmavky sa odmeria 3,0 ml pyridinového roztoku diethylamidodithiouhličitanu strieborného. Potom sa do pristroja opatrné vnesie 3 g granulovaného zinku, prostého arzénu a banka sa ihned' uzavře připojením na přístroj, nikajúci vodík sa nechá prechádzať absorpčnou skúmavkou po dobu 60 minút. Ak sa oslabí priebeh vývoja vodíka, přidá sa do nálevky pristroja ďalší podřel dýmavej kyseliny chlorovodíkovej, prostej arzénu, alebo malé množstvo roztoku chloridu cínatého, ktorým sa zinok aktivuje. Rovnako sa vykoná skúška so slepou vzorkou. Pyridinový roztok dietylamidodithiouhličitanu strieborného sa nesmie sfarbiť intenzivnejšie vo vzorke, ako v porovnávacom roztoku.Pipette 20 ml of the test sample into the flask of the arsenic instrument, add 5 ml of fuming hydrochloric acid, free of arsenic, 2 ml of potassium iodide solution (15 g / L) and 0,5 ml of stannous chloride solution. The mixture is thoroughly mixed and allowed to stand for 15 minutes to reduce arsenic compounds, if present, to arsenic. Meanwhile, cotton wool impregnated with lead acetate to collect hydrogen sulfide was placed in a glass tube connecting the two parts of the apparatus and a 3.0 ml pyridine solution of silver diethylamidodithium carbonate was measured into the absorption tube. Then, 3 g of arsenic-free granulated zinc is carefully introduced into the apparatus and the flask is immediately closed by attaching to the apparatus, leaving the leaking hydrogen through the absorption tube for 60 minutes. If the evolution of hydrogen is weakened, an additional amount of fuming hydrochloric acid, arsenic-free, or a small amount of tin (II) chloride solution to activate the zinc is added to the funnel of the apparatus. A blank test shall also be carried out. The pyridine solution of silver diethylamidodithium carbonate must not be more intensely colored in the sample than in the reference solution.
Příprava pyridinového roztoku dietylamidodithio uhličitanu striebornéhoPreparation of a pyridine solution of diethylamidodithio silver carbonate
0,5 g dietylamidodithiouhličitanu strieborného (CzHsjžNCS . SAg sa rozpustí v čerstvo predestilovanom pyridine na 100 ml roztoku a sfiltruje sa do suchej tmavěj fl'aše so zabrúsenou zátkou.Dissolve 0.5 g of silver diethylamidodithium carbonate (C 5 H 5 N 2 O 3 .Sg) in freshly distilled pyridine per 100 ml of solution and filter into a dry, dark-glass bottle with a ground-glass stopper.
Roztok je stály asi 2 týždne.The solution is stable for about 2 weeks.
8. Barium a stroncium — skúša sa podlá ČSN 62 1156. Chemické zkoušení pryže zdravotně nezávadné následovně:8. Barium and strontium - tested according to ČSN 62 1156. Chemical testing of rubber is safe as follows:
K 5,0 ml skúšaného roztoku sa přidá 0,2 mililitra zriedeného roztoku kyseliny sírovej (500 g/Lj. Do 2 hodin sa nesmie skúšaná vzorka změnit viac, ako porovnávací roztok za rovnakých podmienok.To 5.0 ml of the test solution add 0.2 ml of dilute sulfuric acid solution (500 g / l). Within 2 hours, the test sample must not change more than the reference solution under the same conditions.
9. Boritany — skúša sa podlá metody upravenej pre sposob skúšania gumových zátok v zdravotníctve následovně:9. Borates - Tested according to a method adapted to the method of testing rubber plugs in health as follows:
K 5,0 ml skúšaného roztoku sa přidá 1,0 mililitra roztoku zriedenej kyseliny chlorovodíkovej [10 ml/L), týmto roztokom sa pokvapká, kurkumový papierik. Rovnako sa připraví porovnávací roztok. Kurkumový papierok so vzorkou sa nesmie sfarbiť intenzívnejšie, ako papierik pokvapkaný porovnávacou vzorkou.To 5.0 ml of the test solution add 1.0 ml of dilute hydrochloric acid solution (10 ml / L), dropping turmeric paper dropwise. Prepare a standard solution. The turmeric sample paper shall not be more intensely colored than the paper dropped with the reference sample.
10. Hliník — skúša sa podlá metody upravenej pre sposob skúšania gumových zátok v zdravotníctve následovně:10. Aluminum - shall be tested according to a method adapted to the method of testing rubber stoppers in health care as follows:
K 5,0 ml skúšaného roztoku sa přidá 0,2 mililitra octanu amonného (10 g/L) a 0,2 mililitra roztoku aluminonu — amónna sol' kyseliny aurintrikarbonovej, alebo tetraoxyflavinol (1,0 g/LJ a přidá sa 0,5 ml nasýteného roztoku uhličitanu amonného (dá sa stanovit 1 ^g).To 5.0 ml of the test solution add 0.2 ml of ammonium acetate (10 g / L) and 0.2 ml of aurintricarbonate ammonium ammonium salt solution or tetraoxyflavinol (1.0 g / LJ) and add 0.5 ml of ml of saturated ammonium carbonate solution (1 µg can be determined).
Skúšaný roztok sa nesmie sfarbiť intenzívnejšie červene, ako za rovnakých podmienok připravený porovnávací roztok.The test solution must not be more intensely red than the reference solution prepared under the same conditions.
11. Hořčík, vápník — skúša sa podlá všeobecnej statě pre ČsL4 následovně:11. Magnesium, calcium - is tested according to the general article for CsL4 as follows:
K 10,0 ml skúšaného roztoku sa přidá zriedený roztok amoniaku do zásaditej reakcie, 2,0 ml roztoku chloridu amonného, 5,0 ml roztoku hydrogénfosforečnanu sodného a důkladné sa premieša.To 10.0 ml of the test solution add dilute ammonia solution to the basic reaction, 2.0 ml of ammonium chloride solution, 5.0 ml of sodium hydrogen phosphate solution and mix thoroughly.
Do 15 minút po přidaní roztoku hydrogénfosforečnanu sodného sa nesmie roztok intenzívnejšie zakalit, ako porovnávací roztok za rovnakých podmienok.Within 15 minutes after the addition of the sodium hydrogen phosphate solution, the solution must not become more cloudy than the reference solution under the same conditions.
12. Med — skúša sa podta monografie článku CsL3 Voda na injekciu následovně:12. Honey - is tested according to the monograph of CsL3 Water for Injection as follows:
10,0 ml skúšaného roztoku sa napipetuje do deliaceho lievika, přidá sa 5 kvapiek roztoku chelanutonu 3 c(CioHi4N2Na203) = 0,05 lhol/L a nechá sa stať 2 minúty. Po tom sa přidá 1,0 ml roztoku citronanu amónneho prostého médi a 1,0 ml roztoku diethyldithiokarbaminanu sodného (lg/L). Vytrepáva sa 2 minúty 10 ml roztoku chloridu uhličitého. Vrstva chloridu uhličitého sa oddělí a sfiltruje filtračným papierom o priemere 5 cm. Sfarbenie filtrátu nesmie byť intenzívnejšie, než sfarbenie porovnávacieho roztoku so štandardou, ktorý v rovnakom objeme sa rovnakých podmínek a v rovnakom množstve použitých chemikálií obsahuje 0,2 ^g Cu2+.Pipette 10.0 ml of the test solution into a separatory funnel, add 5 drops of chelanutone 3c solution (C 10 H 14 N 2 Na 2 O 3) = 0.05 lhol / L and allow to stand for 2 minutes. 1.0 ml of medium-free ammonium citrate solution and 1.0 ml of sodium diethyldithiocarbaminate solution (1 g / L) are then added. Shake 10 ml of carbon tetrachloride solution for 2 minutes. The carbon tetrachloride layer was separated and filtered through a 5 cm diameter filter paper. The color of the filtrate must not be more intense than that of a standard solution containing 0,2 µg of Cu 2+ in the same volume under the same conditions and in the same quantity of chemicals used.
Skúšaný roztok sa nesmie sfarbiť intenzívnejšie, ako slepá vzorka porovnávacia za rovnakých podmienok.The test solution must not be more intensely colored than a blank comparative under the same conditions.
Příprava roztoku citronanu amonnéhoPreparation of ammonium citrate solution
21,0 g kyseliny citrónovej sa rozpustí v 75,0 ml roztoku amoniaku cfNHáOH) = 5 mol/L a doplní sa vodou so 100 ml. Přidá sa 1,0 ml roztoku diethyldithiokarbaminanu sodného (lg/L) a niekolkokrát sa pretrepe 5 ml chloridu uhličitého, až je spodná fáza bezfarebná.Dissolve 21.0 g of citric acid in 75.0 ml of 5M ammonia solution and make up to 100 ml with water. Add 1.0 ml of sodium diethyldithiocarbaminate solution (1 g / L) and shake several times with 5 ml of carbon tetrachloride until the lower phase is colorless.
13. Tažké kovy — skúša sa podl'a návrhu všeobecnej statě pre ČsL4 sposobom I. a II. následovně:13. Heavy metals - is tested according to the draft general article for ČsL4 in the manner of I. and II. as follow:
Sposob I. — K 10,0 ml skúšaného roztoku sa přidá 0,50 g chloridu amonného a po jeho rozpuštění 1 kvapka zriedeného roztoku amoniaku, 3 kvapky roztoku sírnika sodného a premieša sa.Method I - To 10.0 ml of the test solution add 0.50 g of ammonium chloride and, after dissolution, 1 drop of dilute ammonia solution, 3 drops of sodium sulphide solution and mix.
Do 2 minút po přidaní sírnika sodného sa skúšaný roztok nesmie sfarbiť intenzívnejšie, ako porovnávací roztok, připravený za rovnakých podmienok.Within 2 minutes of the addition of sodium sulphide, the test solution must not be more intensely colored than the reference solution prepared under the same conditions.
Sposob II. — K dalším 10,0 ml skúšaného roztoku sa přidá 1,0 ml roztoku zriadenej kyseliny octovej, 2,0 ml sírovodíkovej vody a premieša sa.Sposob II. - To a further 10,0 ml of the test solution, add 1,0 ml of dilute acetic acid solution, 2,0 ml of hydrogen sulphide water and mix.
Do 5 minút po přidaní sírovodíkovej vody sa nesmie skúšaný roztok sfarbiť intenzívnejšie, ako porovnávací roztok za rovnakých podmienok.Within 5 minutes of the addition of hydrogen sulphide water, the test solution must not be more intensely colored than the reference solution under the same conditions.
14. Titan —- skúša sa pódia metody upravenej pre sposob skúšania gumových zátok v zdravotnictvo následovně:14. Titanium —- the stage of a method adapted for the method of testing rubber bays in the medical field is tested as follows:
5,0 ml skúšaného rožtoku sa okyselí 2,0 mililitra zriadeného roztoku kyseliny síroia vej, 1,0 ml zriedeného roztoku peroxidu vodíka (30 g/L). Skúšaný roztok sa nesmie sfarbiť intenzívnejšie žito alebo oranžovo, ako porovnávacia vzorka za rovnakých podmienok.Acidify 5.0 ml of the test solution with 2.0 ml of dilute sulfuric acid solution, 1.0 ml of dilute hydrogen peroxide solution (30 g / L). The test solution must not be more intensely colored rye or orange than the reference sample under the same conditions.
(Pozitivna skúška može dokázat 0,01 mg titanu, reakciu ruší Cr a Fe.j(A positive test can show 0.01 mg of titanium, the reaction is disturbed by Cr and Fe
15. Vápník a stroncium — skúša sa pódia návrhu všeobecnej statě pre ČsL4, následovně:15. Calcium and strontium - the stage of the draft general article for CsL4 is tested as follows:
K 10,0 ml skúšaného roztoku sa přidá zriedený roztok amoniaku do zásaditej reakcie, 2,0 ml roztoku šťavelanu amonného a dokladné sa premieša.To 10.0 ml of the test solution add dilute ammonia solution to the basic reaction, 2.0 ml of ammonium oxalate solution and mix thoroughly.
Do 15 minút po přidaní šťavelanu amonného sa nesmie skúšaný roztok zakalit intenzívnejšie, ako porovnávací roztok za rovnakých podmienok.Within 15 minutes of the addition of ammonium oxalate, the test solution must not become more cloudy than the reference solution under the same conditions.
16. Zinok — skúša sa pódia Compendium medicamentorum následovně:16. Zinc - the Compendium medicamentorum stage is tested as follows:
10,0 ml skúšaného roztoku sa nesmie po přidaní 10 kvapiek roztoku kyanoželeznatanu draselného (50 g/L) intenzívnejšie zakalit, ako porovnávací roztok za rovnakých podmienok. Porovnáváme sa vykoná po 5 minútach.After addition of 10 drops of 50 g / l potassium ferrocyanide solution, 10.0 ml of the test solution must not become more opacified than the reference solution under the same conditions. Comparison is carried out after 5 minutes.
17. Železo — skúša sa pódia metody upravenej pre sposob skúšania gumových zátok v zdravotníctve následovně:17. Iron - the stage of the method modified for the method of testing rubber bays in health care is tested as follows:
K 10,0 ml skúšaného roztoku sa přidá niekoiko kryštalkov- persíranu draselného K2S2O3, niekolko kvapiek zriedeného roztoku kyseliny chlorovodíkovej a zahřeje sa. Po přidaní roztoku rodanidu sodného NaCNS sa roztok nesmie sfarbiť intenzívnejšie červene, ako porovnávací roztok.To 10.0 ml of the test solution add a few crystals of potassium persulphate K2S2O3, a few drops of dilute hydrochloric acid solution and heat. After addition of NaCNS solution of sodium rodanide, the solution should not be more intensely red than the reference solution.
18. Soli amónne aminy — skúša sa podlá návrhu všeobecnej statě ČsL4 následovně:18. Salts of ammonium amines - are tested according to the proposal of the general article ČsL4 as follows:
K 10,0 ml skúšaného roztoku sa přidá 0,50 ml Nessler-Winklerovho reagensu, skúmavka sa dokladné pretrepe.To 10.0 ml of the test solution add 0.50 ml of Nessler-Winkler reagent, shake vigorously.
Po 15 minútach sa skúšaný roztok nesmie sfar’ intenzívnejšie žito, ako porovnávací roztok za rovnakých podmienok.After 15 minutes, the test solution must not be more intensely rye than the reference solution under the same conditions.
Příprava Nessler-Winklerovho reagensuPreparation of Nessler-Winkler reagent
5,0 g bromidu draselného sa rozpustí v 10 mililtroch vody, přidá sa 20,0 ml roztoku hydroxidu sodného (220 g/L) a doplní sa vodou na 100 ml. Po 24 hodinách sa sfiltruje. Používá sa číry, bezfarebný roztok. Uchovává sa chráněný před svetlom.Dissolve 5.0 g of potassium bromide in 10 milliliters of water, add 20,0 ml of sodium hydroxide solution (220 g / L) and make up to 100 ml with water. After 24 hours, filter. A clear, colorless solution is used. It is protected from light.
19. Fosforečnany — skúša sa podlá meto230858 dy upravenej pre spósob skúšania gumových zátok v zdravotníctve následovně:19. Phosphates - Tested according to meto230858 dy adapted for the method of testing rubber plugs in health as follows:
Do 25ml Erlenmayerovej banky na kovový cín sa odpipetuje 10,0 ml skúšanej vzorky, přidá sa niekolko kryštálov chloridu sodného a 5 kvapiek roztoku molybdenanu amonného v kyselině sírovej. Skúšaná vzorka sa nesmie sfarbiť intenzívnejšie modro, ako porovnávacia vzorka za rovnakých podmienok.Pipette 10.0 ml of the test sample into a 25 ml metal tin Erlenmeyer flask, add a few sodium chloride crystals and 5 drops of a solution of ammonium molybdate in sulfuric acid. The test sample shall not be more intensely blue than the reference sample under the same conditions.
Příprava molybdenanu amónneho v kyselině sírovejPreparation of ammonium molybdate in sulfuric acid
2,0 g molybdenanu amónneho sa rozpustí v 20 ml vody a naleje sa na 60 ml zriedeného roztoku kyseliny sírovej (500 g/L).Dissolve 2.0 g of ammonium molybdate in 20 ml of water and pour into 60 ml of dilute sulfuric acid solution (500 g / L).
20. Chloridy — skúša sa podía návrhu všeobecnej statě pre ČsL4 následovně:20. Chlorides - is tested according to the draft general article for CsL4 as follows:
!>10,0 ml skúšaného roztoku sa okyselí 1,0 mililitra zriedeného roztoku kyseliny sírovej, pridajú sa 3 kvapky dusičnanu srieborného c (AgNOsj = 0,1 mol/L, dokladné sa pretrepe.> 10.0 ml of the test solution is acidified with 1.0 ml of dilute sulfuric acid solution, 3 drops of silver nitrate c (AgNO5 = 0.1 mol / L) are added, shaking vigorously.
Po 5 minutách skúšaný roztok nesmie opalizovať intenzívnejšie, ako porovnávací roztok za rovnakých podmienok.After 5 minutes, the test solution must not tan more intensively than the reference solution under the same conditions.
21. Sírany — skúša sa podía návrhu všeobecnej statě pre CsL4 následovně:21. Sulphates - tested according to the draft general article for CsL4 as follows:
K 10,0 ml skúšaného roztoku sa přidá 0,5 mililitra zriedeného roztoku kyseliny chlorovodíkovej, přidá sa 1,0 ml roztoku chloridu barnatého a důkladné sa 1/2 minúty pretrepáva.To 10.0 ml of the test solution add 0.5 ml of dilute hydrochloric acid solution, add 1.0 ml of barium chloride solution and shake vigorously for 1/2 minute.
Do 15 minút po pretrepaní sa nesmie skúšaný roztok zakalil viac, ako za rovnakých podmienok připravený porovnávací roztok.Within 15 minutes after shaking, the test solution must not become more turbid than the reference solution prepared under the same conditions.
22. _Sírniky, kyslé sírniky — skúša sa podlá CSN 62 1156 — Zkoušení pryže zdravotně nezávadné následovně:22. _Sulfides, acid sulphides - tested according to CSN 62 1156 - Health testing of rubber as follows:
5,0 ml skúšaného roztoku po priedaní roztoku octanu olovnatého (lg/L) sa nesmie sfarbiť tmavšie, ako porovnávací roztok za rovnakých podmienok.5.0 ml of the test solution after passing the lead (lg / L) solution must not be darker than the reference solution under the same conditions.
23. Thiosírany — skúša sa podlá ČSN 62 1156 — Zkoušení pryže zdravotně nezávadné:23. Thiosulphates - tested according to ČSN 62 1156 - Testing of rubber for health:
K 5,0 ml skúšaného roztoku sa přidá niekolko kvapiek roztoku dusičnanu strieborného c (AgNO3) = 0,1 mol/L. Skúšaný roztok sa nesmie sfarbiť intenzívnejšie, ako porovnávací roztok za rovnakých podmienok.To 5.0 ml of the test solution add a few drops of silver nitrate solution c (AgNO3) = 0.1 mol / L. The test solution must not be more intensely colored than the reference solution under the same conditions.
24. Organické a iné redukúce látky — skúša sa modifikovanou metodou podlá CsL3 následovně:24. Organic and other reducing agents - tested by a modified method according to CsL3 as follows:
Do 300ml dobře vyčistenej Erlenmayerovej banky sa přidá 5,0 ml roztoku zriedenej kyseliny sírovej (400 ml/Lj, přidá sa 10,0 ml roztoku manganistanu draselného c (1/5 KMnOd) = 0,01 mol/L, uzavře sa skleněnou zátkou, vloží sa do vriaceho vodného kúpela. Zahrieva sa 10 minút, potom sa banka vybere, přidá sa 10,0 ml roztoku kyseliny šťavelovej c (C2H2O4. H2O j — 0,01 mol/L. Premieša sa a ihned1 sa titruje roztokom manganistanu draselného c (1/5 KMnCU) = 0,01 mol/L do růžová.To a 300 ml well-cleaned Erlenmeyer flask add 5,0 ml dilute sulfuric acid solution (400 ml / L), add 10,0 ml potassium permanganate solution c (1/5 KMnOd) = 0,01 mol / L, close with a glass stopper Heat for 10 minutes, then remove the flask, add 10,0 ml of oxalic acid solution c (C2H2O4, H2O j - 0,01 mol / L). Mix and titrate immediately with permanganate solution 1 . Potassium c (1/5 KMnCU) = 0.01 mol / L to pink.
Rovnako sa skúška vykoná v porovnávacej vzorke za rovnakých podmienok a sleduje sa rozdiel spotrieb roztoku manganistanu draselného c (1/5 KMnOd) = 0,01 mol/ /L proti skúšanému roztoku.Similarly, carry out the test in the reference sample under the same conditions and observe the difference in consumption of the potassium permanganate solution c (1/5 KMnOd) = 0,01 mol / L against the test solution.
25. Zbytok po odpaření —25. Evaporation residue -
Do vyžíhanej a zváženej platinovej misky sa napipetuje 100 ml skúšaného roztoku, ktorý sa odpaří na vodnom kúpeli do sucha. Potom sa pri 105 °C vysuší do konštantnej hmotnosti. Sleduje sa změna proti porovnávaciemu roztoku.Pipette 100 ml of the test solution into the ignited and weighed platinum dish and evaporate to dryness on a water-bath. It is then dried to constant weight at 105 ° C. Examine the change against the reference solution.
Pri sledovaní nových gumárenských zmesí, alebo zmene pomocných látok pri výrobě zátok používaných v zdravotníctve, je potřebné sledovat, či sa používajú také súčasti pomocných látok, ktoré v uvedenom předpise skúšané nie sú a třeba skúšanie doplnit aj o sledovanie vyluhovatelnosti týchto látok.When monitoring new rubber compounds or changing auxiliaries in the manufacture of medical bays, it is necessary to monitor whether auxiliary components are used that have not been tested in the above-mentioned regulation and need to be supplemented with monitoring of their leachability.
Pre urýchlenie informácie o stárnutí přípravku, može sa vykonat skúšanie aj spósobom podta Compendium medicamentorum v hmotnostnom pomere 8 g zátky a 100 ml vody na injekciu.To speed up the information on aging of the product, testing may also be carried out according to the Compendium medicamentorum weight ratio of 8 g stopper and 100 ml water for injections.
Možnost skúšania vyrobených infúznych roztokov vody na injekciu pre potvrdenie ich kvality a vylúčenia nežiadúceho vplyvu gumovej zátky.Possibility of testing the manufactured water infusion solutions for injection to confirm their quality and to eliminate the undesirable effects of the rubber stopper.
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CS812808A CS230858B1 (en) | 1981-04-14 | 1981-04-14 | Method of defect indicating for medicinal rubber stoppers |
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CS812808A CS230858B1 (en) | 1981-04-14 | 1981-04-14 | Method of defect indicating for medicinal rubber stoppers |
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CS280881A1 CS280881A1 (en) | 1984-01-16 |
CS230858B1 true CS230858B1 (en) | 1984-08-13 |
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Application Number | Title | Priority Date | Filing Date |
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CS812808A CS230858B1 (en) | 1981-04-14 | 1981-04-14 | Method of defect indicating for medicinal rubber stoppers |
Country Status (1)
Country | Link |
---|---|
CS (1) | CS230858B1 (en) |
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1981
- 1981-04-14 CS CS812808A patent/CS230858B1/en unknown
Also Published As
Publication number | Publication date |
---|---|
CS280881A1 (en) | 1984-01-16 |
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