Description

(βr,δr,1S,2S)-1,2-Dihydro-β,δ,6-Trihydroxy-2-Methyl-1-Naphthaleneheptanoic Acid (Pravastatin Impurity) CAS NO 136590-28-8 is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity in the quality control and regulatory compliance of Pravastatin, a widely prescribed cholesterol-lowering medication. It is essential for analytical laboratories and pharmaceutical manufacturers focused on method validation, stability studies, and ensuring drug safety and efficacy. Our supply guarantees the reliability and traceability required for stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of related substances in Pravastatin Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, and other chromatographic methods in quality control laboratories.
• Stability Indicating Studies: Used to monitor the formation of degradation products in Pravastatin under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity profiles for drug master files (DMFs) and marketing authorization applications.
• Pharmacopeial Testing: Employed in testing to meet the stringent impurity limits specified in pharmacopeias such as USP, EP, and JP.
• Research & Development: Used in metabolic studies, synthesis pathway research, and impurity fate and tolerance investigations during drug development.

Basic Information

Product Name	(βr,δr,1S,2S)-1,2-Dihydro-β,δ,6-Trihydroxy-2-Methyl-1-Naphthaleneheptanoic Acid (Pravastatin Impurity)
CAS No.	136590-28-8
Molecular Formula	C₂₃H₃₄O₇
Molecular Weight	422.51 g/mol
Synonyms	Pravastatin Impurity; Pravastatin Related Compound; 1,2-Dihydro-β,δ,6-Trihydroxy-2-Methyl-1-Naphthaleneheptanoic Acid; (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 (isomer); Pravastatin Dihydroxy Acid Impurity; Pravastatin Open Lactone Form; Statin Impurity; Contact for additional synonyms.
EINECS	Contact for details

Quality Control

Every batch of our (βr,δr,1S,2S)-1,2-Dihydro-β,δ,6-Trihydroxy-2-Methyl-1-Naphthaleneheptanoic Acid (Pravastatin Impurity) is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including HPLC purity assay, identification by spectroscopic methods (IR, NMR), and control of specific impurities, to ensure it meets the exacting standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) with batch-specific data is provided to support your regulatory and quality assurance needs.

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 product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to 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.