| 查看: 1958 | 回复: 6 | ||
[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！ |
回复此楼» 猜你喜欢
欢迎发来filecode的Mz6后的代码验证其规律
已经有123人回复
-
今天基金会出结果吗？20260819
已经有13人回复
-
时间戳变了，能看出什么问题？
已经有16人回复
-
filecode，4个jtjc了
已经有13人回复
-
为什么余额宝的年化利率越来越低？主要原因有哪些？
已经有5人回复
-
今天放榜没戏了吧
已经有5人回复
-
今天放榜吗？
已经有15人回复
-
filecode=后面第一个是大写字母
已经有12人回复
-
2027广东省杰青
已经有10人回复
-
朋友圈看到的
已经有8人回复
» 本主题相关价值贴推荐，对您同样有帮助:
- 求助美国药典USP37-NF32中Timolol Maleate的质量标准
已经有1人回复
- 美国药典USP37中benzyl alcohol的标准内容
已经有1人回复
- 美国药典USP37中sugar spheres标准
已经有4人回复
- USP37中EPANOVA制剂的质量标准
已经有2人回复
- USP37的lovaza标准求助
已经有1人回复
- 求USP37里右美托咪定Dexmedetomidine Hydrochloride的质量标准
已经有2人回复
- 急求：USP通则<232>和 <233>的电子版！
已经有1人回复
- 奥美拉唑肠溶胶囊 美国药典USP37版
已经有7人回复
- 美国药典USP36或USP37纯化水检测项目及方法
已经有0人回复
- 求助美国药典USP37 中Olanzapine and Fluoxetine Capsules的标准
已经有2人回复
- 美国药典USP37中的<208>Anti-Factor Xa to Anti-Factor IIa Ratio
已经有2人回复
- USP37 肝素钠
已经有10人回复
- 美国药典和上版相比修改了哪些内容要在哪个章节中进行查看
已经有1人回复
ienjoysun
银虫 (著名写手)
- 应助: 5 (幼儿园)
- 金币: 4739.9
- 散金: 83
- 红花: 4
- 帖子: 2441
- 在线: 207.2小时
- 虫号: 494917
- 注册: 2008-01-14
- 专业: 药物毒理
【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
ienjoysun
银虫 (著名写手)
- 应助: 5 (幼儿园)
- 金币: 4739.9
- 散金: 83
- 红花: 4
- 帖子: 2441
- 在线: 207.2小时
- 虫号: 494917
- 注册: 2008-01-14
- 专业: 药物毒理
3楼2014-05-04 16:44:29
4楼2015-01-20 18:27:33
ienjoysun
银虫 (著名写手)
- 应助: 5 (幼儿园)
- 金币: 4739.9
- 散金: 83
- 红花: 4
- 帖子: 2441
- 在线: 207.2小时
- 虫号: 494917
- 注册: 2008-01-14
- 专业: 药物毒理
5楼2015-01-21 08:30:05
hengruicyj
金虫 (正式写手)
- 应助: 27 (小学生)
- 金币: 2299.1
- 红花: 2
- 帖子: 474
- 在线: 214.3小时
- 虫号: 2687340
- 注册: 2013-09-28
- 性别: GG
- 专业: 有机合成
6楼2015-03-20 04:48:51
ienjoysun
银虫 (著名写手)
- 应助: 5 (幼儿园)
- 金币: 4739.9
- 散金: 83
- 红花: 4
- 帖子: 2441
- 在线: 207.2小时
- 虫号: 494917
- 注册: 2008-01-14
- 专业: 药物毒理
【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 |
7楼2015-03-20 09:56:07
