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Atorvastatin Related Compound C

Pharmaceutical Secondary Standard; Certified Reference Material

RR)-2,3-Bis(4-fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid hemicalcium salt
Empirical Formula (Hill Notation):
CAS Number:
Molecular Weight:

Quality Level


certified reference material
pharmaceutical secondary standard


current certificate can be downloaded


pkg of 30 mg





pharmacopeia traceability

traceable to PhEur Y0001330
traceable to USP 1044549

storage temp.

-10 to -25°C

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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.


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.
Atorvastatin may be used as a pharmaceutical reference standard for the determination of the analyte in drug dosage forms by chromatography techniques.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP 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.

Storage Class Code

13 - Non Combustible Solids



Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Certificate of Origin

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)
HPLC methods for the determination of simvastatin and atorvastatin
Novakova L, et al.
TrAC, Trends in Analytical Chemistry, 27(4), 352-367 (2008)
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)

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