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小木虫论坛-学术科研互动平台 » 生物医药区 » 药品生产 » 质量管理 » 美国药典USP37中Ascorbyl Palmitate质量标准
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106041003

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[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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1楼2014-05-04 10:14:14
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ienjoysun

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【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.
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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
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3楼2014-05-04 16:44:29
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fygcpu

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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？
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4楼2015-01-20 18:27:33
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ienjoysun

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

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【答案】应助回帖

内容已删除
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希望到这里能和大家学习学习，互相帮助。
6楼2015-03-20 04:48:51
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ienjoysun

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【答案】应助回帖

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
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7楼2015-03-20 09:56:07
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