Description

Ortho-Hydroxy Atorvastatin is a key pharmaceutical intermediate and an important impurity reference standard in the production and quality control of Atorvastatin, the active ingredient in leading cholesterol-lowering medications. Its precise synthesis and high purity are critical for ensuring the efficacy, safety, and regulatory compliance of the final drug product. This compound is essential for manufacturers and analytical laboratories in the global pharmaceutical and fine chemical industries focused on cardiovascular therapeutics.

Application

• Pharmaceutical Intermediate: A critical building block in the synthesis of Atorvastatin calcium.
• Reference Standard: Used as an impurity standard in HPLC and other analytical methods for drug substance and product testing.
• Process Development & Validation: Employed in R&D for route scouting, optimization, and manufacturing process validation.
• Quality Control (QC) & Quality Assurance (QA): Essential for establishing specifications, conducting stability studies, and ensuring batch-to-batch consistency.
• Regulatory Compliance: Supports regulatory filings (e.g., ANDA, NDA) by providing characterized impurity profiles.
• Research Chemical: Used in academic and industrial research to study the metabolism and structure-activity relationships of statins.

Basic Information

Product Name	Ortho-Hydroxy Atorvastatin
CAS No.	214217-86-4
Molecular Formula	C33H35FN2O5
Molecular Weight	558.65 g/mol
Synonyms	(3R,5R)-7-[2-(4-Fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic Acid; Atorvastatin Ortho-Hydroxy Impurity; Atorvastatin Related Compound C; Ortho-Hydroxy Atorvastatin Free Acid; 2-Hydroxy Atorvastatin; Atorvastatin Impurity C
EINECS	Contact for details

Quality Control

Our Ortho-Hydroxy Atorvastatin is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets stringent specifications for use as a pharmaceutical reference standard. Certificates of Analysis (COA) detailing all test results are provided and can be tailored to support specific pharmacopeial (USP, EP) or internal method requirements.

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 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
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.