Description

Pravastatin Impurity A is a high-purity chemical reference standard, specifically identified as a key impurity in the synthesis and quality control of the cholesterol-lowering drug Pravastatin. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API). It is primarily used by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, stability studies, and impurity profiling for statin-based therapeutics.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Pravastatin Impurity A in Pravastatin API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities during drug manufacturing.
• Quality Control & Assurance (QC/QA): Serves as a critical component in routine batch release testing to ensure drug purity meets pharmacopeial standards (USP, EP, ICH).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive impurity characterization data for health authorities like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to study the pathways of impurity formation and to develop purer synthesis routes for Pravastatin.

Basic Information

Product Name	Pravastatin Impurity A
CAS No.	250737-12-3
Molecular Formula	C23H34O7
Molecular Weight	422.52 g/mol
Synonyms	Pravastatin EP Impurity A; Pravastatin Related Compound A; (3R,5R)-7-[(1S,2S,6S,8S,8aR)-6-Hydroxy-2-methyl-8-{[(2S)-2-methylbutanoyl]oxy}-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoic Acid; 1-Naphthaleneheptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, (1S-(1α(βS*,δS*),2β,6β,8β(R*),8aβ))-; Pravastatin Impurity 1
EINECS	Contact for details

Quality Control

Our Pravastatin Impurity A is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is characterized using advanced techniques including HPLC, MS, and NMR to confirm its suitability as a reference standard. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, assay, and impurity profile, supporting compliance with ICH Q3A/B guidelines and pharmacopeial requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. This material is hygroscopic (moisture-sensitive) and should be handled under inert atmosphere when appropriate to ensure long-term stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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