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【求助】求助几个药品的国外质量标准
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求助几个药品的国外质量标准 pramipexole，moxifloxacin，imatinib，sitafloxacin，linezolid 求助以上药品的国外质量标准，如USP,EP,JP,UK. 谢谢！ |
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uu325(金币+4): 谢啦 2011-04-25 12:36:20
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Moxifloxacin Hydrochloride (mox'' i flox' a sin hye'' droe klor' ide) C21H24FN3O4·HCl 437.89 (4aS-cis)-1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl)-4-oxo-3-quinolinecarboxylic acid, monohydrochloride; 1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid, monohydrochloride [186826-86-8]. DEFINITION Moxifloxacin Hydrochloride contains NLT 98.0% and NMT 102.0% of C21H24FN3O4·HCl, calculated on the anhydrous basis. IDENTIFICATION • A. Infrared Absorption 197K • B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. • C. Identification Tests—General, Chloride 191: Meets the requirements Sample solution: To a solution (1 in 160) add diluted nitric acid, and filter. ASSAY • Procedure Buffer: Dissolve 0.5 g of tetrabutylammonium hydrogen sulfate and 1.0 g of monobasic potassium phosphate in water, add 2 mL of phosphoric acid, dilute with water to 1000 mL, mix, and pass through a 0.45-µm filter. Mobile phase: Methanol and Buffer (7:18) Diluent: Add 20 mg of anhydrous sodium sulfite to 1000 mL of Buffer solution, mix gently, and pass through a 0.45-µm filter. System suitability solution: 0.1 and 0.001 mg/mL of USP Moxifloxacin Hydrochloride RS and USP Moxifloxacin Related Compound A RS, respectively, in Diluent Standard solution: 0.1 mg/mL of USP Moxifloxacin Hydrochloride RS in Diluent Sample solution: 0.1 mg/mL of moxifloxacin hydrochloride in Diluent Chromatographic system (See Chromatography 621, System Suitability.) Mode: LC Detector: UV 293 nm Column: 4.0-mm × 25-cm; 5-µm packing L11 Flow rate: 0.9 mL/min Temperature: 45 Injection size: 25 µL System suitability Samples: System suitability solution and the Standard solution [Note—The relative retention times are about 1.0 and 1.2, respectively. ] Suitability requirements Resolution: NLT 1.5 between moxifloxacin and moxifloxacin related compound A, System suitability solution Column efficiency: NLT 4000 theoretical plates, Standard solution Tailing factor: NMT 2.0, Standard solution Relative standard deviation: NMT 2.0%, Standard solution Analysis Samples: Standard solution and Sample solution Calculate the percentage of C21H24FN3O4·HCl in the portion of moxifloxacin hydrochloride taken: Result = (rU/rS) × (CS/CU) × 100 rU = = peak response from the Sample solution rS = = peak response from the Standard solution CS = = concentration of USP Moxifloxacin Hydrochloride RS in the Standard solution (mg/mL) CU = = nominal concentration of moxifloxacin hydrochloride in the Sample solution (mg/mL) Acceptance criteria: 98.0%–102.0% on the anydrous basis IMPURITIES Inorganic Impurities • Residue on Ignition 281: NMT 0.1% • Chloride and Sulfate, Sulfate 221 Analysis: 0.6 g shows no more sulfate than corresponds to 0.25 mL of 0.020 N sulfuric acid. Acceptance criteria: NMT 0.04% Organic Impurities • Procedure: [Note—Protect solutions from light. ] Mobile phase and Diluent: Prepare as directed in the Assay. Blank solution: Use the Diluent. System suitability solution: Prepare as directed in the Assay. Sensitivity solution: 0.05 µg/mL of USP Moxifloxacin Hydrochloride RS from the Standard solution in Diluent [Note—Store the Sensitivity solution under refrigeration and protected from light. ] Standard solution: 2 µg/mL of USP Moxifloxacin Hydrochloride RS in Diluent Sample solution: Prepare as directed in the Assay. Chromatographic system: Proceed as directed in the Assay. System suitability Samples: System suitability solution, Sensitivity solution, and Standard solution Suitability requirements Resolution: NLT 1.5 between moxifloxacin and moxifloxacin related compound A, System suitability solution Column efficiency: NLT 4000 theoretical plates, Standard solution Tailing factor: NMT 2.0, Standard solution Relative standard deviation: NMT 2.0%, Standard solution Signal-to-noise ratio: NLT 10, Sensitivity solution Analysis Samples: Blank solution, Standard solution, and Sample solution Calculate the percentage of each impurity in the portion of moxifloxacin hydrochloride taken: Result = (rU/rS) × (CS/CU) × (1/F) × 100 rU = = peak response of each impurity from the Sample solution rS = = peak response of moxifloxacin hydrochloride from the Standard solution CS = = concentration of USP Moxifloxacin Hydrochloride RS in the Standard solution (mg/mL) CU = = nominal concentration of moxifloxacin hydrochloride in the Sample solution (mg/mL) F = = relative response factor (see Impurity Table 1) Acceptance criteria Individual impurities: See Impurity Table 1. Total impurities: NMT 1.0% Impurity Table 1 Name Relative Retention Time Relative Response Factor Acceptance Criteria, NMT % Moxifloxacin related compound Aa 1.15 1.0 0.1 6,8-Dimethoxyb 1.32 0.71 0.1 8-Ethoxyc 1.48 1.0 0.1 6-Methoxy-8-fluorod 1.71 1.0 0.1 8-Hydroxye 1.83 0.29 0.1 Other individual impurity — 1.0 0.1 Total impurities — — 0.5 a 1-Cyclopropyl-6,8-difluoro-7-[(4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-1,4-dihydroquinoline-3-carboxylic acid. b 1-Cyclopropyl-6,8-dimethoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-1,4-dihydroquinoline-3-carboxylic acid. c 1-Cyclopropyl-8-ethoxy-6-fluoro-7-[(4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-1,4-dihydroquinoline-3-carboxylic acid. d 1-Cyclopropyl-8-fluoro-6-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-1,4-dihydroquinoline-3-carboxylic acid. e 1-Cyclopropyl-6-fluoro-8-hydroxy-7-[(4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-1,4-dihydroquinoline-3-carboxylic acid. SPECIFIC TESTS • Optical rotation, Specific rotation 781S Sample: 10 mg/mL in acetonitrile and water (1:1) Acceptance criteria: 125 to 138 at 20 • Microbial Enumeration Tests 61 and Tests for Specified Microorganisms 62: Total aerobic microbial count: NMT 1000 cfu/g Total combined molds and yeasts count: NMT 100 cfu/g • pH 791: Sample solution: 0.2 in 100 Acceptance criteria: 3.9–4.6 • Water Determination Method Ia 921: NMT 4.5% ADDITIONAL REQUIREMENTS • Packaging and Storage: Preserve in tight, light-resistant containers. Store at room temperature. • USP Reference Standards 11 USP Moxifloxacin Hydrochloride RS USP Moxifloxacin Related Compound A RS Auxiliary Information— Please check for your question in the FAQs before contacting USP. Topic/Question Contact Expert Committee Monograph Behnam Davani, Ph.D., M.B.A. Senior Scientist 1-301-816-8394 (MDAA05) Monograph Development-Antivirals and Antimicrobials 61 Radhakrishna S Tirumalai, Ph.D. Senior Scientific Liaison 1-301-816-8339 (MSA05) Microbiology and Sterility Assurance 62 Radhakrishna S Tirumalai, Ph.D. Senior Scientific Liaison 1-301-816-8339 (MSA05) Microbiology and Sterility Assurance Reference Standards Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org USP33–NF28 Page 3929 Pharmacopeial Forum: Volume No. 34(5) Page 1170 Chromatographic Column— MOXIFLOXACIN HYDROCHLORIDE Chromatographic columns text is not derived from, and not part of, USP 33 or NF 28. |
2楼2011-03-16 20:07:40
