Description

Ortho-Hydroxy Atorvastatin Calcium Salt is a key pharmaceutical intermediate and impurity standard used in the development and quality control of statin medications. This compound is critical for ensuring the purity, safety, and efficacy of atorvastatin-based therapies, which are widely prescribed for managing cholesterol levels. It is primarily utilized by pharmaceutical manufacturers, research institutions, and analytical laboratories involved in API synthesis, method validation, and regulatory compliance. The product is supplied with full traceability and documentation to meet stringent industry requirements.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis of Atorvastatin Calcium, the active pharmaceutical ingredient (API) in leading cholesterol-lowering drugs.
• Reference Standard: Serves as a certified impurity standard for HPLC, LC-MS, and other analytical methods to quantify and control related substances in final API and drug products.
• Process Development & Research: Used in R&D for route scouting, process optimization, and studying the metabolism and degradation pathways of atorvastatin.
• Quality Assurance/Control (QA/QC): Essential for establishing and validating analytical procedures to ensure batch-to-batch consistency and compliance with pharmacopeial standards (USP, EP).
• Regulatory Documentation: Provides a characterized impurity for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive understanding and control of the manufacturing process.

Basic Information

Item	Details
Product Name	Ortho-Hydroxy Atorvastatin Calcium Salt
CAS No.	265989-47-7
Molecular Formula	C33H35FN2O6•1/2Ca
Molecular Weight	605.65 g/mol (for C33H35FN2O6•1/2Ca)
Synonyms	Atorvastatin Impurity F (Ortho-Hydroxy); (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 Related Compound F; o-Hydroxy Atorvastatin Calcium; Atorvastatin EP Impurity F; Atorvastatin Hydroxy Impurity; Calcium bis((3R,5R)-7-[2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate)
EINECS	Contact for details

Quality Control

Our Ortho-Hydroxy Atorvastatin Calcium Salt is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC for purity, identification by IR and NMR, and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical development. Certificates of Analysis (COA) with detailed chromatograms and spectral data are provided for full traceability and regulatory support.

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 should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm

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