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PHR1438 Supelco

Simvastatin

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym: Simvastatin

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Properties

Related Categories Additional Standards, Analytical Standards, Analytical/Chromatography, Chromatography, I-Z,
grade   certified reference material
  pharmaceutical secondary standard
InChI Key   RYMZZMVNJRMUDD-HGQWONQESA-N
mp   127-132 °C (lit.)
Featured Industry   Pharmaceutical (small molecule)
format   neat
pharmacopeia traceability   traceable to BP 739
  traceable to PhEur S0650000
  traceable to USP 1612700

Description

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.

Application

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.

Footnote

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.

Safety & Documentation

Safety Information

RIDADR 
NONH for all modes of transport
WGK Germany 
2
RTECS 
EK7798000

Documents

Certificate of Analysis

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Protocols & Articles

Articles

HPLC Analysis of Cholesterol-Lowering Drugs (Statins) on Discovery® Cyano

From our library of Articles, Sigma-Aldrich presents HPLC Analysis of Cholesterol-Lowering Drugs (Statins) on Discovery® Cyano
Keywords: Chromatography, High performance liquid chromatography, Pharmaceutical

Peer-Reviewed Papers
15

References

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