1A01970
USP
(R)-Amlodipine
Pharmaceutical Analytical Impurity (PAI)
别名:
(R)-Amlodipine, 3-ethyl 5-methyl (R)-2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
等级
pharmaceutical analytical impurity (PAI)
Agency
USP
API类
amlodipine
制造商/商品名称
USP
应用
pharmaceutical
包装形式
neat
储存温度
2-8°C
SMILES字符串
Clc1c(cccc1)[C@H]2C(=C(NC(=C2C(=O)OC)C)COCCN)C(=O)OCC
InChI
1S/C20H25ClN2O5/c1-4-28-20(25)18-15(11-27-10-9-22)23-12(2)16(19(24)26-3)17(18)13-7-5-6-8-14(13)21/h5-8,17,23H,4,9-11,22H2,1-3H3/t17-/m1/s1
InChI key
HTIQEAQVCYTUBX-QGZVFWFLSA-N
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一般描述
USP PAI are a product line of impurities suitable for research and analytical purposes, which help to ensure the quality and safety of medicines.
Associated Drug Substance: Amlodipine
For more information about this PAI, visit here.
应用
特点和优势
1. Conduct analytical tests during early formulation feasibility studies.
2. Determine degradation impurities produced during stress studies.
3. Develop, validate, and transfer analytical methods.
4. Perform spiking studies during process R&D to demonstrate depletion upon recrystallization.
5. Record retention times and/or spectra
6. Determine relative response factors.
7. Identify unknown impurities that formed during ICH stability conditions.
8. Identify impurities that are present in the Reference Listed Drug
9. Test for and profile impurities not listed in drug substance and drug product monographs.
分析说明
其他说明
警示用语:
Danger
危险分类
Acute Tox. 3 Oral - Aquatic Acute 1 - Aquatic Chronic 1 - Eye Dam. 1 - STOT RE 2
储存分类代码
6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
WGK
WGK 3
闪点(°F)
Not applicable
闪点(°C)
Not applicable
法规信息
相关内容
提供适用USP-NF各论的全面标化的一级标准物质,可用于检验药物成分和剂型、药用辅料、食品和膳食补充剂。
Order from a broad range of highly characterized primary reference standard materials to use with USP-NF monographs for the testing of drug substances & dosage forms, pharmaceutical excipients, food ingredients and dietary supplements.
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