Description

Pitavastatincalcium is the calcium salt form of Pitavastatin, a synthetic, highly potent HMG-CoA reductase inhibitor. This active pharmaceutical ingredient (API) is critical for the formulation of cholesterol-lowering medications, offering high efficacy at low doses. It is primarily required by pharmaceutical manufacturers and research institutions for the development and production of finished dosage forms targeting hyperlipidemia and cardiovascular disease management.

Application

• Pharmaceutical API: Primary use as the active ingredient in oral solid dosage forms (tablets, capsules) for the treatment of hypercholesterolemia and mixed dyslipidemia.
• Cardiovascular Drug Formulation: Key component in statin-based therapies designed to reduce LDL cholesterol and triglyceride levels while increasing HDL cholesterol.
• Clinical Research: Utilized in preclinical and clinical studies investigating new therapeutic regimens, combination therapies, or novel drug delivery systems for lipid management.
• Generic Drug Manufacturing: Serves as the core API for the production of generic versions of Pitavastatin calcium-based medications following patent expiry.
• Reference Standard: Used as a high-purity chemical standard in analytical laboratories for quality control, method development, and regulatory compliance testing.

Basic Information

Product Name	Pitavastatincalcium
CAS No.	121659-03-8
Molecular Formula	C50H46CaF2N2O8 • xH2O
Molecular Weight	Anhydrous: 880.98 g/mol
Synonyms	Pitavastatin Calcium; Livalo (brand name); NK-104 calcium salt; (3R,5S,6E)-7-[2-Cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxyhept-6-enoic acid calcium salt; Itavastatin calcium; Nisvastatin calcium; Pivasta; Zypitamag
EINECS	Contact for details

Quality Control

Our Pitavastatincalcium is manufactured under strict quality management systems, targeting compliance with ICH Q7 guidelines and relevant pharmacopeial standards (e.g., USP, EP). Every batch undergoes comprehensive analytical testing including identification, assay, impurity profiling, and residual solvent analysis. A Certificate of Analysis (COA) detailing all test results is provided to ensure full traceability and quality assurance for your pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is hygroscopic (moisture-sensitive) and must be kept in a low-humidity environment. For long-term storage, consider desiccants or inert atmosphere packaging to maintain stability.

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, anhydrous basis)	98.0% - 102.0%
Water Content (KF)	≤ 5.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Microbial Enumeration	Complies with Ph. Eur. 2.6.12 / USP <61>

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