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Merck
모든 사진(1)

문서

1A00050

USP

Rosuvastatin Ketone

Pharmaceutical Analytical Impurity (PAI)

동의어(들):

(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

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About This Item

실험식(Hill 표기법):
C22H26FN3O6S
CAS Number:
Molecular Weight:
479.52
UNSPSC 코드:
41116107
NACRES:
NA.24

Grade

pharmaceutical analytical impurity (PAI)

Agency

USP

API family

rosuvastatin

제조업체/상표

USP

응용 분야

pharmaceutical

형식

neat

저장 온도

2-8°C

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일반 설명

(3R,6E)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl]-3-hydroxy-5-oxohept-6-enoic acid is a USP Pharmaceutical Analytical Impurity (PAI).

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.

애플리케이션

(3R,6E)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl]-3-hydroxy-5-oxohept-6-enoic acid (USP PAI) is intended for use in analytical testing to detect, identify, and measure pharmaceutical impurities.

특징 및 장점

USP PAI advance your early analytical R&D and process development. PAI can be used in the following applications:

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.

분석 메모

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  

기타 정보

Sales restrictions may apply.

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point (°F)

Not applicable

Flash Point (°C)

Not applicable


시험 성적서(COA)

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관련 콘텐츠

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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