Description

Para-Hydroxy Atorvastatin Calcium Salt is a key pharmaceutical intermediate and impurity standard in the synthesis of atorvastatin, a leading statin medication. This high-purity compound is critical for ensuring the quality, safety, and efficacy of the final active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, research institutions, and analytical laboratories for process development, quality control, and regulatory compliance.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis of Atorvastatin Calcium, the active ingredient in cholesterol-lowering drugs.
• Reference Standard: Used as an analytical standard in HPLC, LC-MS, and other chromatographic methods for quantifying impurities and degradation products in atorvastatin API and finished dosage forms.
• Process Development & Research: Essential for R&D chemists working on new synthetic routes, process optimization, and scale-up studies for statin production.
• Quality Control & Assurance: Employed in in-house QC laboratories to validate analytical methods, establish specifications, and ensure batch-to-batch consistency of the final API.
• Regulatory Compliance: Supports regulatory filings (e.g., ANDA, DMF) by providing a characterized impurity standard for stability studies and method validation reports.
• Metabolite Studies: Used in pharmacological and pharmacokinetic research to study the metabolism and biological activity of atorvastatin derivatives.

Basic Information

Item	Detail
Product Name	Para-Hydroxy Atorvastatin Calcium Salt
CAS No.	265989-44-4
Molecular Formula	C66H68CaF2N4O10
Molecular Weight	1155.32 g/mol
Synonyms	Atorvastatin Hydroxy Acid Impurity Calcium Salt; (3R,5R)-7-[2-(4-Fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic Acid Calcium Salt (2:1); Atorvastatin EP Impurity H Calcium Salt; Atorvastatin Related Compound H; Atorvastatin Carboxylate Calcium Salt; Para-Hydroxy Atorvastatin; 4'-Hydroxy Atorvastatin Calcium
EINECS	Contact for details

Quality Control

Our Para-Hydroxy Atorvastatin Calcium Salt is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via IR and NMR, to ensure it meets stringent specifications for pharmaceutical use. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting compliance with relevant pharmacopeial standards (e.g., USP, EP) and in-house specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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 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 individual impurity ≤ 0.5%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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