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[求助]
美國藥典USP37中Ascorbyl Palmitate質(zhì)量標(biāo)準(zhǔn) 已有2人參與
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| 如題，急求最新生效的USP37，我需要其中的Ascorbyl Palmitate專論的復(fù)印件或掃描件。謝謝了！ |
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fygcpu
金蟲 (初入文壇)
- 應(yīng)助: 0 (幼兒園)
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- 專業(yè): 合成藥物化學(xué)
4樓2015-01-20 18:27:33
ienjoysun
銀蟲 (著名寫手)
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【答案】應(yīng)助回帖
感謝參與，應(yīng)助指數(shù) +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樓2014-05-04 16:42:56
ienjoysun
銀蟲 (著名寫手)
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- 注冊: 2008-01-14
- 專業(yè): 藥物毒理
3樓2014-05-04 16:44:29
ienjoysun
銀蟲 (著名寫手)
- 應(yīng)助: 5 (幼兒園)
- 金幣: 4739.9
- 散金: 83
- 紅花: 4
- 帖子: 2441
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- 蟲號: 494917
- 注冊: 2008-01-14
- 專業(yè): 藥物毒理
5樓2015-01-21 08:30:05
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