CN101482544B - Detection method for cefuroxime sodium polymer impurity - Google Patents
Detection method for cefuroxime sodium polymer impurity Download PDFInfo
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- CN101482544B CN101482544B CN2009100250523A CN200910025052A CN101482544B CN 101482544 B CN101482544 B CN 101482544B CN 2009100250523 A CN2009100250523 A CN 2009100250523A CN 200910025052 A CN200910025052 A CN 200910025052A CN 101482544 B CN101482544 B CN 101482544B
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- 239000012535 impurity Substances 0.000 title claims abstract description 47
- 229960000534 cefuroxime sodium Drugs 0.000 title claims abstract description 40
- URDOHUPGIOGTKV-JTBFTWTJSA-M Cefuroxime sodium Chemical compound [Na+].N([C@@H]1C(N2C(=C(COC(N)=O)CS[C@@H]21)C([O-])=O)=O)C(=O)\C(=N/OC)C1=CC=CO1 URDOHUPGIOGTKV-JTBFTWTJSA-M 0.000 title claims abstract description 39
- 238000001514 detection method Methods 0.000 title claims abstract description 22
- 229920000642 polymer Polymers 0.000 title abstract description 4
- WEVYAHXRMPXWCK-UHFFFAOYSA-N Acetonitrile Chemical compound CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 claims abstract description 30
- 239000008363 phosphate buffer Substances 0.000 claims abstract description 25
- 238000004128 high performance liquid chromatography Methods 0.000 claims abstract description 15
- 239000007859 condensation product Substances 0.000 claims description 44
- 238000000034 method Methods 0.000 claims description 10
- 239000000126 substance Substances 0.000 claims description 7
- 238000013459 approach Methods 0.000 claims description 5
- 238000001819 mass spectrum Methods 0.000 claims description 5
- 150000002500 ions Chemical class 0.000 claims description 3
- 230000005526 G1 to G0 transition Effects 0.000 claims description 2
- 238000006471 dimerization reaction Methods 0.000 claims description 2
- 238000006068 polycondensation reaction Methods 0.000 claims description 2
- 229920003053 polystyrene-divinylbenzene Polymers 0.000 claims description 2
- 238000005829 trimerization reaction Methods 0.000 claims description 2
- 238000004458 analytical method Methods 0.000 abstract description 4
- 229920005654 Sephadex Polymers 0.000 abstract description 3
- 239000012507 Sephadex™ Substances 0.000 abstract description 3
- 230000007547 defect Effects 0.000 abstract 1
- 238000002347 injection Methods 0.000 abstract 1
- 239000007924 injection Substances 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
- 239000012071 phase Substances 0.000 description 21
- 239000000463 material Substances 0.000 description 10
- 238000012360 testing method Methods 0.000 description 9
- 238000002360 preparation method Methods 0.000 description 4
- WFIYPADYPQQLNN-UHFFFAOYSA-N 2-[2-(4-bromopyrazol-1-yl)ethyl]isoindole-1,3-dione Chemical compound C1=C(Br)C=NN1CCN1C(=O)C2=CC=CC=C2C1=O WFIYPADYPQQLNN-UHFFFAOYSA-N 0.000 description 3
- 238000002474 experimental method Methods 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 239000013558 reference substance Substances 0.000 description 3
- CDBYLPFSWZWCQE-UHFFFAOYSA-L sodium carbonate Substances [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 description 3
- 229930186147 Cephalosporin Natural products 0.000 description 2
- 239000003782 beta lactam antibiotic agent Substances 0.000 description 2
- 229940124587 cephalosporin Drugs 0.000 description 2
- 150000001780 cephalosporins Chemical class 0.000 description 2
- 239000003153 chemical reaction reagent Substances 0.000 description 2
- 238000011161 development Methods 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 239000000945 filler Substances 0.000 description 2
- 238000005227 gel permeation chromatography Methods 0.000 description 2
- 239000007791 liquid phase Substances 0.000 description 2
- 238000011160 research Methods 0.000 description 2
- 229910000029 sodium carbonate Inorganic materials 0.000 description 2
- 239000002132 β-lactam antibiotic Substances 0.000 description 2
- 229940124586 β-lactam antibiotics Drugs 0.000 description 2
- 241000208340 Araliaceae Species 0.000 description 1
- -1 Cefuroxime Sodium molecular ion Chemical class 0.000 description 1
- 229920001503 Glucan Polymers 0.000 description 1
- 235000005035 Panax pseudoginseng ssp. pseudoginseng Nutrition 0.000 description 1
- 235000003140 Panax quinquefolius Nutrition 0.000 description 1
- 239000004793 Polystyrene Substances 0.000 description 1
- 230000002052 anaphylactic effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 238000004587 chromatography analysis Methods 0.000 description 1
- 239000012501 chromatography medium Substances 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 239000008367 deionised water Substances 0.000 description 1
- 229910021641 deionized water Inorganic materials 0.000 description 1
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 description 1
- 229910000397 disodium phosphate Inorganic materials 0.000 description 1
- 235000019800 disodium phosphate Nutrition 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000012634 fragment Substances 0.000 description 1
- 239000007863 gel particle Substances 0.000 description 1
- 235000008434 ginseng Nutrition 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- TWNIBLMWSKIRAT-VFUOTHLCSA-N levoglucosan Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@H]2CO[C@@H]1O2 TWNIBLMWSKIRAT-VFUOTHLCSA-N 0.000 description 1
- 239000002808 molecular sieve Substances 0.000 description 1
- 229910000403 monosodium phosphate Inorganic materials 0.000 description 1
- 235000019799 monosodium phosphate Nutrition 0.000 description 1
- 239000002547 new drug Substances 0.000 description 1
- QLFFCLRSMTUBEZ-UHFFFAOYSA-N phosphoric acid;sodium Chemical compound [Na].[Na].OP(O)(O)=O QLFFCLRSMTUBEZ-UHFFFAOYSA-N 0.000 description 1
- 229920002223 polystyrene Polymers 0.000 description 1
- 238000004237 preparative chromatography Methods 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- URGAHOPLAPQHLN-UHFFFAOYSA-N sodium aluminosilicate Chemical compound [Na+].[Al+3].[O-][Si]([O-])=O.[O-][Si]([O-])=O URGAHOPLAPQHLN-UHFFFAOYSA-N 0.000 description 1
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
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Abstract
The invention relates to a detection method of polymer impurity or condensate impurity in cefuroxime sodium. The detection method uses the high performance liquid chromatography, wherein the condition of the high performance liquid chromatography are: polystyrene-DVB polymer column: MKF-GPC-10,4-10Mum,(100-300) *(8.0-4.6)mm(I.D.), the mobile phase composition volume ratio: the volume ratio of phosphate buffer (pH=6-8) of 0.005-0.1mol/L to acetonitrile is 60-80:40-20, flow rate: 0.8-1.2 mL/min, detection wavelength: 254 +- 10nm, injection volume: 10-20MuL. The detection method conquers the defects of the former Sephadex analysis of long analysis time and high instrument requirement.
Description
(1) technical field
The present invention relates to a kind of high performance liquid chromatography (HPLC) detection method, being specifically related to a kind of is the analytical approach of polymkeric substance or condensation product impurity in the detection Cefuroxime Sodium of carrier of separating with the Aquapak A-440 chromatographic media.
(2) background technology
Beta-Lactam antibiotic uses in clinical extensively, a large amount of experiments and clinical trial have proved that all wherein various polymeric impurities (are called " polymkeric substance " with such impurity usually in the art, but should belong to the dimerization condensation product from mechanism and structural molecule amount, or trimerization condensation product, or poly condensation product, or the potpourri of different condensation products, therefore, hereinafter hold concurrently to adopt " condensation product ") be the real anaphylactogen that causes type, therefore detect and the control product in the content of condensation product impurity be to reduce the anaphylactoid fundamental way of beta-Lactam antibiotic [referring to Jin Shaohong, Hu Changqin, Chinese Journal of New Drugs, 1994,3 (4), 38～41; Hu Changqin, Zhao Jianxi, Jin Shaohong, Sun Xuelan, Chinese microbiotic magazine, 1991,16 (4), 270～275].The present detection of this kind impurity is that the soft gel chromatography of principle is main method [referring to Hu Changqin, Jin Shaohong, Sun Xuelan, Chinese microbiotic magazine, 1990,15 (5), 357～362] with the molecular sieve, and this kind method does not need special impurity standard items to contrast.Chinese Pharmacopoeia 2000 and 2005 editions have also increased with the method inspection item [Chinese Pharmacopoeia Commission to condensation product, Pharmacopoeia of People's Republic of China, version in 2005, Beijing: Chemical Industry Press, 2005,141], but the used Sephadex G-10 filler of gel chromatography is a kind of hydrophilic gel, its bad mechanical strength, a little less than the anti-pressure ability, need use low-pressure type (preparation) chromatograph during detection, and this gel particle diameter is 40～120 μ m, causes this method to exist post to imitate shortcomings such as low, that analytical cycle is long.
Therefore, be badly in need of a kind of analytical approach that can carry out fast detecting to the condensation product impurity of cephalosporins medicine of development research.
(3) summary of the invention
The objective of the invention is a kind of analytical approach that can carry out the condensation product impurity of cephalosporins medicine fast, accurately detect of development research.
Technical scheme of the present invention is as follows, the rapid analysis of a kind of Cefuroxime Sodium and condensation product impurity high performance liquid chromatography thereof, it is the superpolymer chromatographic column of stationary phase that its characteristics are to adopt a kind of porous type polystyrene-divinylbenzene multipolymer, and the high performance liquid chromatography operating conditions is:
A. superpolymer chromatographic column: MKF-GPC-10,4～10 μ m, (100～300) * (8.0～4.6) mm (I.D.);
B. the volume ratio of the phosphate buffer of moving phase: 0.005～0.1mol/L (pH=6～8) and acetonitrile is 60～80: 40～20;
C. flow velocity: 0.8～1.2mL/min, sample size: 10～20 μ L, column temperature: room temperature;
D. adopt the UV detecting device, the detection wavelength is 254 ± 10nm.
Compared with prior art, advantage of the present invention and effect are as follows:
1, the present invention can successively separate condensation product impurity and Cefuroxime Sodium, and can accurately measure the content of its condensation product impurity, and condensation product impurity to go out the peak position more fixing, be beneficial to the problem that solves its location.
2, the only about 0.5h of whole test analysis overall process, (analytical cycle is about 4～5h) to be compared, and has shortened detection time greatly with existing version Chinese Pharmacopoeia technology in 2005.
3, the present invention can not need special low pressure preparative chromatography at the enterprising line operate of common high performance liquid chromatograph, and lower to the requirement of detecting instrument, the method popularization is good.
With the comparison of official method referring to table 1
The comparison of each parameter during the separating condensed thing impurity of table 1 polystyrene columns and glucosan post (ginseng pharmacopeia 2005)
(4) description of drawings:
Fig. 1 is the chromatogram of Cefuroxime Sodium in sephadex column, wherein 1,2 represents condensation product impurity peaks and Cefuroxime Sodium peak respectively.
Fig. 2 is the mass spectrogram of the Cefuroxime Sodium condensation product chromatographic peak of collection.
Fig. 3 is Cefuroxime Sodium and makes condensation product impurity by oneself at MKF-GPC-10 (100mm * 7.8mm, 5 μ m) the HPLC figure in, the phosphate buffer of moving phase: 0.01mol/L (pH7.0)-acetonitrile (70: 30) wherein, flow velocity: 1mL/min, line 1,2 represent the chromatogram of cefuroxime sodium sample and self-control condensation product impurity respectively.
Fig. 4 is Cefuroxime Sodium and makes condensation product impurity by oneself at MKF-GPC-10 (100mm * 7.8mm, 5 μ m) the HPLC figure in, the phosphate buffer of moving phase: 0.02mol/L (pH7.5)-acetonitrile (75: 25) wherein, flow velocity: 0.8mL/min, line 1,2 represent the chromatogram of cefuroxime sodium sample and self-control condensation product impurity respectively.
Fig. 5 is Cefuroxime Sodium and makes condensation product impurity by oneself at MKF-GPC-10 (100mm * 7.8mm, 5 μ m) the HPLC figure in, the phosphate buffer of moving phase: 0.02mol/L (pH7.0)-acetonitrile (60: 40) wherein, flow velocity: 0.8mL/min, line 1,2 represent the chromatogram of cefuroxime sodium sample and self-control condensation product impurity respectively.
Fig. 6 is Cefuroxime Sodium and makes condensation product impurity by oneself at MKF-GPC-10 (200mm * 7.8mm, 8 μ m) the HPLC figure in, the phosphate buffer of moving phase: 0.005mol/L (pH6.5)-acetonitrile (70: 30) wherein, flow velocity: 1mL/min, line 1,2 represent the chromatogram of cefuroxime sodium sample and self-control condensation product impurity respectively.
Fig. 7 is Cefuroxime Sodium and the HPLC figure of self-control condensation product impurity in MKF-GPC-10 (200mm * 7.8mm, 10 μ m), the phosphate buffer of moving phase: 0.01mol/L (pH7.0)-acetonitrile (80: 20) wherein, flow velocity: 0.8mL/min.
Fig. 8 is Cefuroxime Sodium and the HPLC figure of self-control condensation product impurity in MKF-GPC-10 (300mm * 7.8mm, 6 μ m), the phosphate buffer of moving phase: 0.01mol/L (pH7.0)-acetonitrile (70: 30) wherein, flow velocity: 1mL/min.
Fig. 9 is Cefuroxime Sodium and the HPLC figure of self-control condensation product impurity in MKF-GPC-10 (300mm * 7.8mm, 8 μ m), the phosphate buffer of moving phase: 0.1mol/L (pH7.0)-acetonitrile (70: 30) wherein, flow velocity: 1mL/min.
Figure 10 is Cefuroxime Sodium and the HPLC figure of self-control condensation product impurity in MKF-GPC-10 (250mm * 4.6mm, 4 μ m), the phosphate buffer of moving phase: 0.01mol/L (pH8.0)-acetonitrile (70: 30) wherein, flow velocity: 0.8mL/min.
Figure 11 is Cefuroxime Sodium and the HPLC figure of self-control condensation product impurity in MKF-GPC-10 (250mm * 4.6mm, 8 μ m), the phosphate buffer of moving phase: 0.01mol/L (pH6.0)-acetonitrile (70: 30) wherein, flow velocity: 1.2mL/min.
(5) specific embodiments
Experiment equipment and reagent:
(1) experimental apparatus:
Wear peace Summit type highly effective liquid phase chromatographic system (U.S. Dai An company), AKTA explorer 100 preparative scale chromatography systems (general electronic corporation medical treatment group); API2000 type mass spectrometer (u.s.a. applied biosystem company);
(2) chromatographic column:
MKF-GPC-10 type chromatographic column (MKF-GPC-10,4-10 μ m, 100 (or 200, or 300) * 7.8mm, or 250 * 4.6mm (I.D.), Nanjing Mai Kefei high efficiency separation carrier company limited); Sephadex G-10 sephadex (general electronic corporation medical treatment group).
(3) experiment reagent:
Cefuroxime Sodium; Acetonitrile; Sodium dihydrogen phosphate and sodium hydrogen phosphate; Phosphoric acid; Sodium carbonate; The high performance liquid chromatogram deionized water.The preparation of Cefuroxime Sodium condensation product impurity reference substance:
(1) Cefuroxime Sodium test sample-1 ,-2 preparation:
Get the about 500mg of cefuroxime sodium sample, the accurate title, decide, and puts in the 10mL volumetric flask, and the 0.02mol/mL phosphate buffer is settled to scale, gets Cefuroxime Sodium test sample-1, (now joining) to be measured temporarily.
Get the about 500mg of cefuroxime sodium sample, the accurate title, decide, and puts in the 10mL volumetric flask, adds the 0.01mol/mL sodium carbonate liquor and be settled to scale, and (placement) destruction 12h gets Cefuroxime Sodium test sample-2 under the room temperature, and is to be measured.
(2) chromatographic condition:
Detection machine (preparing instrument): (AKTA explorer 100); Chromatographic column: with Sephadex G-10 (40～120 μ m) is filling agent; Glass column internal diameter 1.3～1.5cm, bed volume 50～60mL.Moving phase: 0.02mol/mL phosphate buffer; Flow velocity: 1.5mL/min; Detect wavelength: 254nm; Sample size: 500 μ L;
(3) acquisition of Cefuroxime Sodium condensation product impurity reference substance
Use above-mentioned chromatographic condition, sample introduction Cefuroxime Sodium test sample-1 respectively, Cefuroxime Sodium test sample-2, Fig. 1, wherein A, B are respectively test sample-1,2 chromatogram.By Fig. 1-A as seen, it is not obvious that the 20mL place goes out impurity peaks, is difficult to determine, and is unfavorable for the mensuration of condensation product impurity.By Fig. 1-B as seen, the impurity content at 20mL place obviously increases, and is the condensation product impurity peaks according to this peak of decidable described in the Chinese Pharmacopoeia 2005 editions.Collect 20～25mL place effluent among Fig. 1-B, as Cefuroxime Sodium condensation product impurity reference substance ,-20 ℃ of preservations treat that the MKF-GPC-10 post detects.The preparation of Cefuroxime Sodium test sample-3:
Get the about 10mg of cefuroxime sodium sample, the accurate title, decide, and is settled to 10ml with the 0.01mol/mL phosphate buffer, (now joining) to be measured temporarily.
The MKF-GPC-10 method the mass spectrum of separating condensed thing impurity determine:
The mass spectrum condition: the ESI ionization source, negative ion mode, polarizing voltage-4200V, sample introduction speed 5 μ L/min, sample frequency 1s, mass range 500～1500Da, spectrogram have superposeed 128 times,
The mass spectrum of condensation product impurity peaks is determined
Collect the condensation product impurity chromatographic peak that is separated in the following example, doing mass spectrum determines, the results are shown in Figure 2, contain m/z in the mass spectrogram and be fragment ion peaks such as 859,577, greater than Cefuroxime Sodium molecular ion peak (m/z is 446), therefore illustrate in this collection liquid and contain macromolecular impurity that what can further determine among the embodiment to be separated be the condensation product impurity peaks.
Chromatographic condition: detection machine: wear peace Summit type highly effective liquid phase chromatographic system; Chromatographic column: MKF-GPC-10 (100mm * 7.8mm, 5 μ m); The phosphate buffer of moving phase: 0.01mol/L (pH7.0)-acetonitrile (70: 30); Flow velocity: 1mL/min; Detect wavelength: 254nm; Sample size: 20 μ L; Sample introduction material: test sample-3, result such as Fig. 3.
Chromatographic condition: detecting instrument, chromatographic column, detection wavelength, sample size, sample introduction material be with embodiment 1, the phosphate buffer of moving phase: 0.02mol/L (pH7.5)-acetonitrile (75: 25); Flow velocity: 0.8mL/min, result such as Fig. 4.
Embodiment 3
Chromatographic condition: detecting instrument, chromatographic column, detection wavelength, sample size, sample introduction material be with embodiment 1, the phosphate buffer of moving phase: 0.02mol/L (pH7.0)-acetonitrile (60: 40); Flow velocity: 0.8mL/min, result such as Fig. 5.
Embodiment 4
Chromatographic condition: detecting instrument, detect wavelength, flow velocity, sample introduction material with embodiment 1, chromatographic column: MKF-GPC-10 (200mm * 7.8mm, 8 μ m), sample size: 10 μ L; The phosphate buffer of moving phase: 0.005mol/L (pH6.5)-acetonitrile (70: 30), result such as Fig. 6.
Chromatographic condition: detecting instrument, detection wavelength, sample size, sample introduction material are with embodiment 1, chromatographic column: MKF-GPC-10 (200mm * 7.8mm, 10 μ m), the phosphate buffer of moving phase: 0.01mol/L (pH7.0)-acetonitrile (80: 20), flow velocity: 0.8ml/min, result such as Fig. 7.
Chromatographic condition: detecting instrument, detection wavelength, flow velocity, sample size, sample introduction material are with embodiment 1, chromatographic column: MKF-GPC-10 (300mm * 7.8mm, 6 μ m), the phosphate buffer of moving phase: 0.01mol/L (pH7.0)-acetonitrile (70: 30), result such as Fig. 8.
Embodiment 7
Chromatographic condition: detecting instrument, detection wavelength, flow velocity, sample size, sample introduction material are with embodiment 1, chromatographic column: MKF-GPC-10 (300mm * 7.8mm, 8 μ m), the phosphate buffer of moving phase: 0.1mol/L (pH7.0)-acetonitrile (70: 30), result such as Fig. 9.
Chromatographic condition: detecting instrument, detection wavelength, sample size, sample introduction material are with embodiment 1, chromatographic column: MKF-GPC-10 (250mm * 4.6mm, 4 μ m), the phosphate buffer of moving phase: 0.01mol/L (pH8.0)-acetonitrile (70: 30), flow velocity: 0.8ml/min, result such as Figure 10.
Embodiment 9
Chromatographic condition: detecting instrument, detection wavelength, sample size, sample introduction material are with embodiment 1, chromatographic column: MKF-GPC-10 (250mm * 4.6mm, 8 μ m), the phosphate buffer of moving phase: 0.01mol/L (pH6.0)-acetonitrile (70: 30), flow velocity: 1.2ml/min result such as Figure 11.
Chromatographic condition: detecting instrument, detect wavelength, flow velocity, sample size, sample introduction material with embodiment 1, chromatographic column: MKF-GPC-10 (250mm * 4.6mm, 5 μ m), the phosphate buffer of moving phase: 0.01mol/L (pH7.0)-acetonitrile (70: 30).
Claims (2)
1. the analytical approach of polymkeric substance or condensation product impurity in the high performance liquid chromatography fast measuring Cefuroxime Sodium is characterized in that, said method comprising the steps of:
A. selecting for use of superpolymer chromatographic column: MKF-GPC-10,4～10 μ m, (100～300) * (8.0～4.6) mm, 8.0～4.6mm is I.D.;
B. the volume ratio of the phosphate buffer of moving phase: 0.005～0.1mol/L, pH=6～8 and acetonitrile is 60～80: 40～20;
C. flow velocity: 0.8～1.2mL/min, sample size: 10～20 μ L, column temperature: room temperature;
D. adopt the UV detecting device, the detection wavelength is 254 ± 10nm;
Described polymkeric substance or condensation product impurity are by Mass Spectrometer Method, and its mass spectrum condition is: ESI ionization source, negative ion mode, polarizing voltage-4200V, sample introduction speed 5 μ L/min, sample frequency 1s, mass range 500～1500Da;
Described superpolymer chromatographic column is the filling of porous type polystyrene-divinylbenzene multipolymer chromatographic stationary phase.
2. the analytical approach of polymkeric substance or condensation product impurity in the fast measuring Cefuroxime Sodium according to claim 1, it is characterized in that polymkeric substance or condensation product impurity are one or more of dimerization condensation product, trimerization condensation product and poly condensation product of cefuroxime sodium molecule in the Cefuroxime Sodium.
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| CN102351883A (en) * | 2011-08-21 | 2012-02-15 | 苏州二叶制药有限公司 | Detection method and production process for ceftizoxime sodium preparation |
| CN103063751A (en) * | 2011-10-20 | 2013-04-24 | 苏州赛分科技有限公司 | Detection method for determining polymer impurities in mezlocillin sodium |
| CN114252516B (en) * | 2020-09-25 | 2023-07-28 | 北京新领先医药科技发展有限公司 | Method for detecting polymer in cefuroxime sodium |
| CN114166963B (en) * | 2021-11-22 | 2023-06-30 | 北京悦康科创医药科技股份有限公司 | Two-dimensional detection method for impurities in cefuroxime sodium |
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