Description

Dihydroxy Diketo Atorvastatin Impurity is a key process-related impurity and degradation product of the widely prescribed cholesterol-lowering drug, Atorvastatin. Its precise identification and quantification are critical for ensuring the purity, safety, and efficacy of the final Active Pharmaceutical Ingredient (API) in compliance with stringent regulatory guidelines. This high-purity reference standard is essential for pharmaceutical manufacturers and analytical laboratories engaged in method development, stability studies, and quality control of Atorvastatin calcium.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Atorvastatin API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Stability Indicating Studies: Used to assess the degradation pathways and shelf-life of Atorvastatin under various stress conditions (e.g., heat, light, humidity).
• Quality Control & Batch Release: Serves as a system suitability standard and for setting impurity acceptance criteria in pharmaceutical quality control laboratories.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over impurities.
• Research & Development: Used in synthetic chemistry research to study the formation and fate of this specific impurity during the Atorvastatin manufacturing process.

Basic Information

Item	Details
Product Name	Dihydroxy Diketo Atorvastatin Impurity
CAS No.	1046118-44-8
Molecular Formula	C33H35FN2O6
Molecular Weight	574.64 g/mol
Synonyms	Atorvastatin Dihydroxy Diketo Impurity; Atorvastatin Impurity 1; Atorvastatin Related Compound; (3R,5R)-7-[2-(4-Fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid; Atorvastatin Degradant; Atorvastatin EP Impurity; Atorvastatin USP Impurity
EINECS	Contact for details

Quality Control

Our Dihydroxy Diketo Atorvastatin Impurity is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC purity determination, residual solvent analysis, and structural confirmation (NMR, MS), to ensure it meets the high standards required for pharmaceutical analysis. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The compound is hygroscopic (moisture-sensitive); ensure the container is sealed in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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