Active Pharmaceutical Ingredient

Pravastatin Sodium — CAS 81131-70-6

Also known as: Pravachol sodium; Sodium pravastatin

GMP Certified IP / BP / USP HMG-CoA Reductase Inhibitor (Statin) Aurangabad, India
Pravastatin Sodium API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Pravastatin Sodium IP / BP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 81131-70-6

Product Overview

Pravastatin Sodium is the sodium salt form of pravastatin, a competitive HMG-CoA reductase inhibitor used to lower LDL cholesterol and triglycerides. The sodium salt form offers improved aqueous solubility for pharmaceutical formulation. Mediocon Inc manufactures Pravastatin Sodium API at its GMP-certified facility in Aurangabad, Maharashtra, India.

Therapeutic Applications
  • Hypercholesterolemia and mixed dyslipidemia management
  • Reduction of cardiovascular morbidity and mortality in at-risk patients
  • Pediatric familial hypercholesterolemia (ages 8 and above)
  • Combined with bile acid sequestrants for enhanced lipid lowering

Technical Specifications

ParameterSpecification
CAS Number81131-70-6
Molecular FormulaC23H35NaO7
Molecular Weight446.51 g/mol
GradeIP / BP / USP
CategoryHMG-CoA Reductase Inhibitor (Statin)
AppearanceWhite to off-white, crystalline powder
SolubilityFreely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Batch NoPRVS/24032026
Mfg DateMAR 2026
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement

Quality & Compliance

  • GMP Certified manufacturing facility in Aurangabad, Maharashtra, India
  • Full pharmacopoeial compliance: IP / BP / USP standards
  • Complete documentation: Certificate of Analysis (CoA), MSDS, Certificate of Origin
  • Stringent in-process quality control at every manufacturing stage
  • HPLC purity testing and spectroscopic identification (IR, NMR)
  • Cold-chain and controlled-environment storage facilities available
  • Exported to 40+ countries with full regulatory support
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