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美国药典USP37中Ascorbyl Palmitate质量标准 已有2人参与
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| 如题，急求最新生效的USP37，我需要其中的Ascorbyl Palmitate专论的复印件或扫描件。谢谢了！ |
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ienjoysun
银虫 (著名写手)
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【答案】应助回帖
感谢参与，应助指数 +1
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Ascorbyl Palmitate (as kore' bil pal' mi tate). C22H38O7414.53 l-Ascorbic acid, 6-hexadecanoate; l-Ascorbic acid 6-palmitate [137-66-6]. DEFINITION Ascorbyl Palmitate contains NLT 95.0% and NMT 100.5% of C22H38O7, calculated on the dried basis. IDENTIFICATION • A. Procedure Sample solution: 40 mg/mL in alcohol Analysis: To 25 mL of Sample solution add 1 mL of a 1-in-1000 solution of 2,6-dichlorophenol-indophenol sodium in alcohol. Acceptance criteria: The blue color of the 2,6-dichlorophenol-indophenol sodium solution is discharged immediately. • B. Infrared Absorption 197K ASSAY • Procedure Sample solution: Dissolve 300 mg of Ascorbyl Palmitate in 50 mL of alcohol, and add 30 mL of water. Analysis: Immediately titrate the Sample solution with 0.1 N iodine VS to a yellow color that persists for NLT 30 s. Each mL of 0.1 N iodine is equivalent to 20.73 mg of C22H38O7. Acceptance criteria: 95.0%–100.5% on the dried basis IMPURITIES Inorganic Impurities • Residue on Ignition 281: NMT 0.1% • Heavy Metals, Method II231: NMT 10 ppm SPECIFIC TESTS • Melting Range or Temperature 741: 107–117 • Optical Rotation, Specific Rotation781S: +21 to +24 Sample solution: 100 mg/mL, in methanol • Loss on Drying 731: Dry a sample in vacuum at 60 for 1 h: it loses NMT 2.0% of its weight. ADDITIONAL REQUIREMENTS • Packaging and Storage: Preserve in tight containers, in a cool, dry place. • USP Reference Standards 11 USP Ascorbyl Palmitate RS Auxiliary Information— Please check for your question in the FAQs before contacting USP. Topic/Question Contact Expert Committee Monograph Galina Holloway, Ph.D. Scientific Liaison (301) 816-8133 (EXC2010) Monographs - Excipients Reference Standards RS Technical Services 1-301-816-8129 rstech@usp.org USP37–NF32 Page 5856 Pharmacopeial Forum: Volume No. 38(6) Chromatographic Column— ASCORBYL PALMITATE Chromatographic columns text is not derived from, and not part of, USP 37 or NF 32. |
2楼2014-05-04 16:42:56
ienjoysun
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3楼2014-05-04 16:44:29
4楼2015-01-20 18:27:33
ienjoysun
银虫 (著名写手)
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5楼2015-01-21 08:30:05
hengruicyj
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6楼2015-03-20 04:48:51
ienjoysun
银虫 (著名写手)
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【答案】应助回帖
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Glucosamine Hydrochloride C6H13NO5·HCl215.63 d-Glucose, 2-amino-2-deoxy-, hydrochloride; 2-Amino-2-deoxy--d-glucopyranose hydrochloride [66-84-2]. DEFINITION Glucosamine Hydrochloride contains NLT 98.0% and NMT 102.0% of glucosamine hydrochloride (C6H13NO5·HCl), calculated on the dried basis. IDENTIFICATION • A. Infrared Absorption 197K • B. Identification Tests—General, Chloride191: Meets the requirements • C. The retention time of the glucosamine peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. ASSAY • Procedure Buffer: In a 1-L volumetric flask, dissolve 3.5 g of dibasic potassium phosphate in water. Add 0.25 mL of ammonium hydroxide, dilute with water to volume, and mix. Adjust with phosphoric acid to a pH of 7.5. Mobile phase: Acetonitrile and Buffer (75:25) Diluent: Acetonitrile and water (50:50) Standard solution: 3.8 mg/mL of USP Glucosamine Hydrochloride RS in Diluent Sample solution: 3.8 mg/mL of Glucosamine Hydrochloride in Diluent. [Note—Shake by mechanical means to aid dissolution. ] Chromatographic system (See Chromatography 621, System Suitability.) Mode: LC Detector: UV 195 nm Column: 4.6-mm × 15-cm; 5-µm packing L8 Column temperature: 35 Flow rate: 1.5 mL/min Injection size: 10 µL System suitability Sample: Standard solution [Note—The peak for the glucosamine moiety elutes at about 10 min. The chromatogram shows a large additional peak near the void volume, due to the chloride ion. ] Suitability requirements Tailing factor: NMT 2.0 for the glucosamine peak Efficiency: NLT 1500 theoretical plates Relative standard deviation: NMT 2.0% Analysis Samples: Standard solution and Sample solution Calculate the percentage of glucosamine hydrochloride (C6H13NO5·HCl) in the portion of Glucosamine 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 Glucosamine Hydrochloride RS in the Standard solution (mg/mL) CU = = concentration of Glucosamine Hydrochloride in the Sample solution (mg/mL) Acceptance criteria: 98.0%–102.0% on the dried basis IMPURITIES • Residue on Ignition 281: NMT 0.1% • Chloride and Sulfate, Sulfate221: A 0.10-g portion shows no more sulfate than corresponds to 0.25 mL of 0.020 N sulfuric acid (NMT 0.24%). • Arsenic, Method II211: NMT 3 ppm • Heavy Metals, Method II231: NMT 10 ppm SPECIFIC TESTS • Optical Rotation, Specific Rotation781S: +70.0 to +73.0 Sample solution: 25 mg/mL. Measure the specific rotation 3 h after preparation. • pH 791 Sample solution: 20 mg/mL Acceptance criteria: 3.0–5.0 • Loss on Drying 731: Dry a sample at 105 for 2 h: it loses NMT 1.0% of its weight. ADDITIONAL REQUIREMENTS • Packaging and Storage: Preserve in tight, light-resistant containers. • USP Reference Standards 11 USP Glucosamine Hydrochloride RS Auxiliary Information— Please check for your question in the FAQs before contacting USP. Topic/Question Contact Expert Committee Monograph Huy T. Dinh, M.S. Senior Scientific Liaison (301) 816-8594 (DS2010) Monographs - Dietary Supplements and Herbal Medicines Reference Standards RS Technical Services 1-301-816-8129 rstech@usp.org USP37–NF32 Page 5424 Pharmacopeial Forum: Volume No. 33(4) Page 691 |
7楼2015-03-20 09:56:07
