Description

Atorvastatin 4-Hydroxy Calcium is a key pharmaceutical intermediate and metabolite of the widely prescribed cholesterol-lowering drug atorvastatin calcium. This compound matters for its critical role in the research, development, and quality control of statin-based therapies, ensuring drug efficacy and safety profiles. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in active pharmaceutical ingredient (API) synthesis, impurity profiling, and metabolic studies.

Application

• Pharmaceutical Intermediate: Synthesis of atorvastatin calcium and related statin analogs.
• Reference Standard: Used as a certified reference material (CRM) for HPLC and LC-MS analysis in quality control laboratories.
• Metabolite Studies: Critical for pharmacokinetic and pharmacodynamic research to understand drug metabolism and activity.
• Impurity Profiling: Serves as a known impurity or degradation product standard for API batch release testing.
• Process Development: Optimization of fermentation or synthetic routes for atorvastatin production.
• Regulatory Submissions: Supporting documentation for drug master files (DMFs) and new drug applications (NDAs).

Basic Information

Product Name	Atorvastatin 4-Hydroxy Calcium
CAS No.	1263176-34-6
Molecular Formula	C33H34FN2O5•1/2Ca
Molecular Weight	584.12 g/mol (free acid)
Synonyms	4-Hydroxy Atorvastatin Calcium Salt; Atorvastatin Hydroxy Acid Calcium; (3R,5R)-7-[2-(4-Fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic Acid Calcium Salt; Atorvastatin EP Impurity C; Atorvastatin Metabolite; Atorvastatin Related Compound C
EINECS	Contact for details

Quality Control

Our Atorvastatin 4-Hydroxy Calcium is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, chiral purity determination, and identification by spectroscopic methods (IR, NMR, MS). We provide full traceability and Certificates of Analysis (COA) are available upon request, detailing all specified parameters to support your regulatory and research 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) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥98.0%
Related Substances (HPLC)	Total impurities ≤2.0% Any single unknown impurity ≤0.5%
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.