Description

Atorvastatin Hemicalcium Trihydrate CAS NO 344423-98-9 is the hemicalcium salt trihydrate form of Atorvastatin, a well-known synthetic lipid-lowering agent. This high-purity active pharmaceutical ingredient (API) is critical for ensuring the efficacy and stability of finished pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers engaged in the research, development, and production of cholesterol-lowering medications.

Application

• Active Pharmaceutical Ingredient (API) in the manufacture of finished dosage forms for cholesterol management.
• Reference Standard for analytical method development and quality control testing in pharmaceutical laboratories.
• Pharmaceutical Intermediates for the synthesis of other Atorvastatin-based compounds.
• Research & Development of new therapeutic formulations and drug delivery systems targeting hyperlipidemia.
• Generic Drug Production for cost-effective alternatives to branded statin medications.
• Clinical Trial Material for studies investigating the safety and efficacy of statin therapies.

Basic Information

Product Name	Atorvastatin Hemicalcium Trihydrate
CAS No.	344423-98-9
Molecular Formula	C66H68CaF2N4O10 • 3H2O
Molecular Weight	1209.41 g/mol (Trihydrate)
Synonyms	Atorvastatin Calcium Trihydrate; Atorvastatin Calcium Salt Trihydrate; (3R,5R)-7-[2-(4-Fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-ylpyrrol-1-yl]-3,5-dihydroxyheptanoic Acid Hemicalcium Salt Trihydrate; Lipitor API; CI-981; SQ-33,060; Atorvastatin (calcium) Trihydrate
EINECS	Contact for details

Quality Control

Our Atorvastatin Hemicalcium Trihydrate is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with current pharmacopeial standards (e.g., USP, EP). A detailed Certificate of Analysis (COA) is provided with every shipment to guarantee traceability and compliance.

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 low-humidity environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	3.0% - 6.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH guidelines
Heavy Metals	≤ 20 ppm
Microbial Enumeration	Complies with EP/USP

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