Active Pharmaceutical Ingredient

Simvastatin

Also known as: Zocor; Simvor; Simlo

CAS: 79902-63-9 HMG-CoA Reductase Inhibitor IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Simvastatin API — Mediocon Inc
Simvastatin — Pharmaceutical Grade API

Product Overview

CAS No: 79902-63-9  |  MF: C₂₅H₃₈O₅  |  MW: 418.57 g/mol

Simvastatin is an HMG-CoA reductase inhibitor (statin) used as an active pharmaceutical ingredient in lipid-lowering therapies. Mediocon Inc supplies high-purity Simvastatin API conforming to IP / BP / EP / USP specifications from our GMP-certified facility in Aurangabad, Maharashtra, India.

Simvastatin reduces elevated total cholesterol, LDL-cholesterol, and triglycerides while increasing HDL-cholesterol. It is widely used in the prevention of cardiovascular events including heart attacks and strokes in high-risk patients.

Key Features

  • High-purity pharmaceutical grade API
  • IP / BP / EP / USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing

Applications

  • Hypercholesterolaemia and mixed dyslipidaemia
  • Cardiovascular event prevention
  • Heterozygous familial hypercholesterolaemia
  • Combined lipid-lowering formulations

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameSimvastatin
Also Known AsZocor; Simvor; Simlo
CAS Number79902-63-9
Molecular FormulaC₂₅H₃₈O₅
Molecular Weight418.57 g/mol
CategoryHMG-CoA Reductase Inhibitor — Statin
AppearanceWhite to off-white crystalline powder
SolubilityPractically insoluble in water; freely soluble in ethanol and chloroform
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / as per requirement
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