1A00050
USP
Rosuvastatin Ketone
Pharmaceutical Analytical Impurity (PAI)
别名:
(3R,6E)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl]-3-hydroxy-5-oxohept-6-enoic acid, (R,E)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-3-hydroxy-5-oxohept-6-enoic acid, (3R,6E)-7-[4-(4-Fluorophenyl)-2-(N-methylmethanesulfonamido)-6-(propan-2-yl)pyrimidin-5-yl]-3-hydroxy-5-oxohept-6-enoic acid, 5-Oxorosuvastatin
About This Item
推荐产品
等級
pharmaceutical analytical impurity (PAI)
agency
USP
API 家族
rosuvastatin
製造商/商標名
USP
應用
pharmaceutical
格式
neat
儲存溫度
2-8°C
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一般說明
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: Rosuvastatin Calcium
Therapeutic Area: Antihyperlipidemics
For more information about this PAI, visit here.
應用
特點和優勢
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.
分析報告
其他說明
儲存類別代碼
11 - Combustible Solids
水污染物質分類(WGK)
WGK 3
閃點(°F)
Not applicable
閃點(°C)
Not applicable
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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