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Pharmaceutical Secondary Standard; Certified Reference Material

Empirical Formula (Hill Notation):
CAS Number:
Molecular Weight:
MDL number:
PubChem Substance ID:

Quality Level


certified reference material
pharmaceutical secondary standard


current certificate can be downloaded


HPLC: suitable
gas chromatography (GC): suitable


127-132 °C (lit.)

Featured Industry

Pharmaceutical (small molecule)



pharmacopeia traceability

traceable to BP 739
traceable to PhEur S0650000
traceable to USP 1612700

SMILES string




InChI key


Gene Information

human ... HMGCR(3156)

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General description

Certified pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to pharmacopeia primary standards.
Simvastatin is a hypolipidemic drug, which lowers plasma cholesterol by inhibiting 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase. It is widely used in the treatment of hypercholesterolemia.


Simvastatin may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by various 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.

Biochem/physiol Actions

Simvastatin is a specific inhibitor of HMG-CoA reductase, the enzyme that catalyzes the conversion of HMG-CoA to mevalonate, an early step in cholesterol biosynthesis. It is used in the treatment of hypercholesterolemia, as it reduces levels of low-density lipoproteins and triglycerides, and raises high-density lipoprotein levels. Simvastatin is a lactone that is readily hydrolyzed in vivo to the corresponding β-hydroxyacid, and can be activated prior to use with NaOH in EtOH treatment. It is a synthetic analog of lovastatin (Cat. No. M2147).

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 LRAB3719 in the slot below. This is an example certificate only and may not be the lot that you receive.


Health hazard

Signal Word


Hazard Statements

Hazard Classifications

Repr. 2

Storage Class Code

11 - Combustible Solids

WGK Germany


Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Certificate of Origin

Simultaneous determination of ezetimibe and simvastatin in pharmaceutical formulations by dual-mode gradient LC.
Ozalt?n N & Ucakturk E
Chromatographia, 66(1), 87-91 (2007)
HPLC determination of ezetimibe and simvastatin in pharmaceutical formulations.
Ashfaq M, et al.
Journal of the Chilean Chemical Society, 52(3), 1220-1223 (2007)
Development of self-microemulsifying drug delivery systems (SMEDDS) for oral bioavailability enhancement of simvastatin in beagle dogs.
Kang BK, et al.
International Journal of Pharmaceutics, 274(1-2), 65-73 (2004)
Determination of lovastatin and simvastatin in pharmaceutical dosage forms by MEKC.
Srinivasu MK, et al.
Journal of Pharmaceutical and Biomedical Analysis, 29(4), 715-721 (2002)
A Marot et al.
Acta clinica Belgica, 66(2), 134-136 (2011-06-03)
Myopathy, including rhabdomyolysis, is a well-known, albeit rare complication of statin therapy. Predisposing factors include comorbidities and the concomitant use of cytochrome P-450 (CYP) 3A4 inhibitors. We report a case of severe simvastatin-induced rhabdomyolysis triggered by the addition of amiodarone...

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