Description

Atorvastatin Calcium CAS NO 134523-03-8 is the active pharmaceutical ingredient (API) of the widely prescribed statin medication used to manage cholesterol levels. This high-purity compound is critical for ensuring the efficacy and safety of finished pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of cardiovascular therapeutics.

Application

• Pharmaceutical API: Primary active ingredient in the manufacture of oral solid dosage forms (tablets, capsules) for cholesterol-lowering medications.
• Generic Drug Production: Essential for formulating generic versions of atorvastatin-based drugs following patent expiry.
• Clinical Research: Used as a reference standard and raw material in preclinical and clinical studies for new cardiovascular treatments.
• Formulation Development: Serves as a key component in R&D for developing novel drug delivery systems and combination therapies.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for commercial-scale API processing and finished product manufacturing.

Basic Information

Product Name	Atorvastatin Calcium
CAS No.	134523-03-8
Molecular Formula	C66H68CaF2N4O10
Molecular Weight	1155.36 g/mol
Synonyms	Atorvastatin Calcium Trihydrate; Atorvastatin Calcium Salt; Lipitor API; CI-981; (βR,δR)-2-(4-Fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic Acid Calcium Salt (2:1); SQ 31,360; Sortis (API).
EINECS	Contact for details

Quality Control

Our Atorvastatin Calcium is manufactured under strict quality systems, targeting compliance with major pharmacopoeial standards such as USP and EP. Every batch undergoes comprehensive analytical testing including HPLC assay, related substances profiling, and residual solvent analysis to ensure identity, purity, and strength. A detailed Certificate of Analysis (COA) is provided with each shipment.

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 dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	NMT 4.5%
Related Substances (HPLC)	Total impurities: NMT 1.0% Any individual impurity: NMT 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	NMT 20 ppm
Microbial Enumeration	Complies with EP/USP <61>

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