Description

Atorvastatin Calcium Hydrate Impurity 39 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Atorvastatin Calcium, a leading active pharmaceutical ingredient (API) in cholesterol-lowering medications. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, stability studies, and impurity profiling to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Atorvastatin Calcium API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing, calibrating, and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Stability Studies & Forced Degradation: Employed to monitor and characterize degradation products formed during stability testing of Atorvastatin-based formulations.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity identification and control strategies.
• Quality Control & Batch Release: Acts as a system suitability standard and for routine quality control testing to ensure API and drug product batches meet specified purity criteria.
• Research & Development: Used in R&D to study the metabolic pathways, synthesis by-products, and degradation mechanisms of Atorvastatin.

Basic Information

Product Name	Atorvastatin Calcium Hydrate Impurity 39
CAS No.	2243639-97-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Atorvastatin Impurity 39; Atorvastatin Related Compound 39; (3R,5R)-7-[2-(4-Fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic Acid Calcium Salt Hydrate Impurity; Atorvastatin Calcium EP Impurity I; Atorvastatin Calcium USP Related Compound; Atorvastatin Calcium Hydrate Specified Impurity
EINECS	Contact for details

Quality Control

Our Atorvastatin Calcium Hydrate Impurity 39 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, LC-MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results. Our quality commitment aligns with cGMP principles to support your regulatory 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 material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Water Content (KF)	Contact for details
Residual Solvents (GC)	Meets ICH limits

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