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Merck
CN

PHR1870

Supelco

阿托伐他汀相关化合物 C

Pharmaceutical Secondary Standard; Certified Reference Material

别名:

RR)-2,3-Bis(4-fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid hemicalcium salt

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About This Item

经验公式(希尔记法):
C66H66CaF4N4O10
分子量:
1191.32
UNSPSC代码:
41116107
NACRES:
NA.24

等级

certified reference material
pharmaceutical secondary standard

质量水平

Agency

traceable to Ph. Eur. Y0001330
traceable to USP 1044549

API类

atorvastatin

CofA

current certificate can be downloaded

包装

pkg of 30 mg

应用

pharmaceutical

包装形式

neat

储存温度

-10 to -25°C

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一般描述

This material is an impurity of atorvastatin. Atorvastatin is a synthetic HMG-CoA reductase inhibitor which lowers plasma cholesterol levels by inhibiting endogenous cholesterol synthesis.
Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.

应用

Atorvastatin may be used as a pharmaceutical reference standard for the determination of the analyte in drug dosage forms by chromatography techniques.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

分析说明

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

其他说明

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

附注

To see an example of a Certificate of Analysis for this material enter LRAB7553 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

相关产品

产品编号
说明
价格

储存分类代码

11 - Combustible Solids

WGK

WGK 3

闪点(°F)

Not applicable

闪点(°C)

Not applicable


分析证书(COA)

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An HPLC method for the determination of atorvastatin and its impurities in bulk drug and tablets
Erturk S, et al.
Journal of Pharmaceutical and Biomedical Analysis, 33(5), 1017-1023 (2003)
HPLC methods for the determination of simvastatin and atorvastatin
Novakova L, et al.
TrAC, Trends in Analytical Chemistry, 27(4), 352-367 (2008)
Atorvastatin associated liver disease
Clarke, AT and Mills, PR
Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver, 38(10), 772-777 (2006)

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