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PHR1870

Atorvastatin Related Compound C

Name: Atorvastatin Related Compound C
Brand: SIAL

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

(βR,δR)-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

Empirical Formula (Hill Notation):

C₆₆H₆₆CaF₄N₄O₁₀

CAS Number:

693793-53-2

Molecular Weight:

1191.32

NACRES:

NA.24

UNSPSC Code:

41116107

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Properties

Quality Level

300

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to Ph. Eur. Y0001330, traceable to USP 1044549

API family

atorvastatin

CofA

current certificate can be downloaded

packaging

pkg of 30 mg

application(s)

pharmaceutical

format

neat

storage temp.

-10 to -25°C

Description

General description

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.

Application

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.

Analysis Note

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

Other Notes

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.

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.

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Storage Class

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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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)

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)

Global Trade Item Number

SKU	GTIN
PHR1870-30MG	04061835220397