JP2004510817A5 - - Google Patents

Info

Publication number

JP2004510817A5

JP2004510817A5 JP2002533858A JP2002533858A JP2004510817A5 JP 2004510817 A5 JP2004510817 A5 JP 2004510817A5 JP 2002533858 A JP2002533858 A JP 2002533858A JP 2002533858 A JP2002533858 A JP 2002533858A JP 2004510817 A5 JP2004510817 A5 JP 2004510817A5

Authority

JP

Japan

Prior art keywords

pravastatin

sodium

composition

impurities

substantially pure

Prior art date

2001-10-05

Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)

Granted

Links

• Espacenet
• Global Dossier
• Discuss

• 229960001495 Pravastatin Sodium Drugs 0.000 claims 45
• VWBQYTRBTXKKOG-IYNICTALSA-M pravastatin sodium Chemical compound [Na+].C1=C[C@H](C)[C@H](CC[C@@H](O)C[C@@H](O)CC([O-])=O)[C@H]2[C@@H](OC(=O)[C@@H](C)CC)C[C@H](O)C=C21 VWBQYTRBTXKKOG-IYNICTALSA-M 0.000 claims 45
• 229960002965 Pravastatin Drugs 0.000 claims 37
• TUZYXOIXSAXUGO-PZAWKZKUSA-N Pravastatin Chemical compound C1=C[C@H](C)[C@H](CC[C@@H](O)C[C@@H](O)CC(O)=O)[C@H]2[C@@H](OC(=O)[C@@H](C)CC)C[C@H](O)C=C21 TUZYXOIXSAXUGO-PZAWKZKUSA-N 0.000 claims 37
• 239000000203 mixture Substances 0.000 claims 32
• 239000012535 impurity Substances 0.000 claims 25
• 239000003960 organic solvent Substances 0.000 claims 16
• 239000002253 acid Substances 0.000 claims 14
• 150000003863 ammonium salts Chemical class 0.000 claims 13
• OQARDMYXSOFTLN-PZAWKZKUSA-N [(1S,3S,7S,8S,8aR)-3-hydroxy-8-[2-[(2R,4R)-4-hydroxy-6-oxooxan-2-yl]ethyl]-7-methyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl] (2S)-2-methylbutanoate Chemical compound C([C@H]1[C@@H](C)C=CC2=C[C@@H](O)C[C@@H]([C@H]12)OC(=O)[C@@H](C)CC)C[C@@H]1C[C@@H](O)CC(=O)O1 OQARDMYXSOFTLN-PZAWKZKUSA-N 0.000 claims 12
• 239000002585 base Substances 0.000 claims 9
• 159000000000 sodium salts Chemical class 0.000 claims 9
• 238000000855 fermentation Methods 0.000 claims 8
• 230000004151 fermentation Effects 0.000 claims 8
• 150000003839 salts Chemical class 0.000 claims 8
• 239000011780 sodium chloride Substances 0.000 claims 8
• 125000000217 alkyl group Chemical group 0.000 claims 7
• QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 claims 6
• 239000012296 anti-solvent Substances 0.000 claims 6
• 238000000354 decomposition reaction Methods 0.000 claims 6
• HEMHJVSKTPXQMS-UHFFFAOYSA-M sodium hydroxide Chemical group [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims 6
• 239000000243 solution Substances 0.000 claims 6
• 238000000605 extraction Methods 0.000 claims 5
• 244000005700 microbiome Species 0.000 claims 5
• 239000007864 aqueous solution Substances 0.000 claims 4
• 238000002425 crystallisation Methods 0.000 claims 4
• 230000005712 crystallization Effects 0.000 claims 4
• FGKJLKRYENPLQH-UHFFFAOYSA-M isocaproate Chemical group CC(C)CCC([O-])=O FGKJLKRYENPLQH-UHFFFAOYSA-M 0.000 claims 4
• 238000001953 recrystallisation Methods 0.000 claims 4
• XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 4
• NLXLAEXVIDQMFP-UHFFFAOYSA-N ammonia chloride Chemical compound [NH4+].[Cl-] NLXLAEXVIDQMFP-UHFFFAOYSA-N 0.000 claims 3
• BDAGIHXWWSANSR-UHFFFAOYSA-N formic acid Chemical compound OC=O BDAGIHXWWSANSR-UHFFFAOYSA-N 0.000 claims 3
• 238000000034 method Methods 0.000 claims 3
• 239000008194 pharmaceutical composition Substances 0.000 claims 3
• FFWSICBKRCICMR-UHFFFAOYSA-N 5-Methyl-2-hexanone Chemical compound CC(C)CCC(C)=O FFWSICBKRCICMR-UHFFFAOYSA-N 0.000 claims 2
• QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Natural products CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims 2
• 230000002378 acidificating Effects 0.000 claims 2
• 239000003637 basic solution Substances 0.000 claims 2
• 239000000284 extract Substances 0.000 claims 2
• 238000004108 freeze drying Methods 0.000 claims 2
• 239000001963 growth media Substances 0.000 claims 2
• 239000003456 ion exchange resin Substances 0.000 claims 2
• 229920003303 ion-exchange polymer Polymers 0.000 claims 2
• 125000004108 n-butyl group Chemical group [H]C([H])([H])C([H])([H])C([H])([H])C([H])([H])* 0.000 claims 2
• 125000004123 n-propyl group Chemical group [H]C([H])([H])C([H])([H])C([H])([H])* 0.000 claims 2
• 230000001376 precipitating Effects 0.000 claims 2
• 238000005185 salting out Methods 0.000 claims 2
• 239000002904 solvent Substances 0.000 claims 2
• 125000000218 acetic acid group Chemical group C(C)(=O)* 0.000 claims 1
• 125000005907 alkyl ester group Chemical group 0.000 claims 1
• 235000019270 ammonium chloride Nutrition 0.000 claims 1
• 150000001732 carboxylic acid derivatives Chemical class 0.000 claims 1
• 239000002552 dosage form Substances 0.000 claims 1
• 235000019253 formic acid Nutrition 0.000 claims 1
• 238000009472 formulation Methods 0.000 claims 1
• 150000007522 mineralic acids Chemical class 0.000 claims 1
• QDHHCQZDFGDHMP-UHFFFAOYSA-N monochloramine Chemical group ClN QDHHCQZDFGDHMP-UHFFFAOYSA-N 0.000 claims 1