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106041003

新虫 (初入文坛)

[求助] 美国药典USP37中Ascorbyl Palmitate质量标准 已有2人参与

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

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这是集团内网的信息。您进不去的
5楼2015-01-21 08:30:05
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ienjoysun

银虫 (著名写手)

【答案】应助回帖

感谢参与,应助指数 +1
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
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ienjoysun

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不知道怎么上传PDF格式文件。这个是从网上复制下来的
3楼2014-05-04 16:44:29
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fygcpu

金虫 (初入文坛)

引用回帖:
3楼: Originally posted by ienjoysun at 2014-05-04 16:44:29
不知道怎么上传PDF格式文件。这个是从网上复制下来的

什么网址 可以告诉我一下吗?
4楼2015-01-20 18:27:33
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