Description

Atorvastatin Calcium Hydrate Impurity 32 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 utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Serves 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: Used as a critical standard to develop, calibrate, and validate chromatographic methods, primarily HPLC and UPLC, for quality control testing.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submissions (e.g., for FDA, EMA) by providing definitive impurity characterization data to meet ICH Q3A/B guidelines.
• Stability Studies: Employed to monitor the formation and levels of this specific impurity during forced degradation and long-term stability testing of drug substances and products.
• Research & Development: Used in R&D laboratories to study the degradation pathways and chemical behavior of Atorvastatin Calcium under various conditions.
• Quality Control (QC) Testing: Acts as a primary standard in QC laboratories for routine batch release testing of Atorvastatin Calcium to ensure it meets stringent purity specifications.

Basic Information

Product Name	Atorvastatin Calcium Hydrate Impurity 32
CAS No.	2088732-01-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Atorvastatin Impurity 32; Atorvastatin Related Compound 32; Atorvastatin Calcium Salt Impurity 32; (3R,5R)-7-[2-(4-Fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic Acid Calcium Salt Impurity; Atorvastatin EP Impurity G; Atorvastatin Process Impurity; Atorvastatin Degradant
EINECS	Contact for details

Quality Control

Our Atorvastatin Calcium Hydrate Impurity 32 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic confirmation (NMR, MS), to ensure identity, potency, and purity meet exacting standards for reference materials. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with every shipment to support your quality and regulatory requirements.

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 desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
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.