Description

Pravastatin Sodium is a selective, competitive HMG-CoA reductase inhibitor widely used as an active pharmaceutical ingredient (API). Its primary value lies in effectively lowering LDL cholesterol and triglyceride levels while raising HDL cholesterol, making it a cornerstone in cardiovascular disease management. This compound is essential for pharmaceutical manufacturers producing oral solid dosage forms, such as tablets, for the global treatment of hypercholesterolemia and dyslipidemia. Pravastatin Sodium CAS NO 81131-70-6 is recognized for its hydrophilic properties and favorable safety profile.

Application

• Pharmaceutical API: Primary use as the active ingredient in cholesterol-lowering medications (e.g., Pravachol®).
• Tablet Formulation: Direct compression or granulation processes for oral solid dosage forms.
• Preventive Cardiology: Formulations aimed at reducing the risk of myocardial infarction, stroke, and revascularization procedures.
• Generic Drug Manufacturing: Sourcing for cost-effective generic pravastatin products post-patent expiration.
• Clinical Research: Used as a reference standard or raw material in pharmacokinetic and pharmacodynamic studies.
• Combination Therapies: Potential use in fixed-dose combination drugs with other cardiovascular agents.

Basic Information

Product Name	Pravastatin Sodium
CAS No.	81131-70-6
Molecular Formula	C₂₃H₃₅NaO₇
Molecular Weight	446.52 g/mol
Synonyms	Pravastatin Sodium Salt; SQ 31,000; Pravastatin Na; CS-514 Sodium Salt; (3R,5R)-7-[(1S,2S,6S,8S,8aR)-6-Hydroxy-2-methyl-8-[(S)-2-methylbutyryloxy]-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoic Acid Sodium Salt; Sodium Pravastatin; Pravastatina Sodica; Pravastatine Sodique
EINECS	Contact for details

Quality Control

Our Pravastatin Sodium is manufactured under strict quality systems, targeting compliance with major pharmacopoeial standards such as USP and EP. Every batch undergoes rigorous analytical testing including HPLC for assay and related substances, residual solvent analysis, and comprehensive identification and microbiological tests. A Certificate of Analysis (COA) documenting full compliance with release specifications is provided with each shipment, ensuring traceability and quality assurance for our global pharmaceutical clients.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water (KF)	≤ 5.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Microbial Enumeration	Complies with EP/JP/USP

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.