Description

Pitavastatin Calcium CAS NO 147526-32-7 is a synthetic, highly potent statin pharmaceutical active ingredient used to manage cholesterol levels. It is a critical intermediate in the production of finished dosage forms for the treatment of hyperlipidemia and the prevention of cardiovascular disease. This high-purity compound is essential for pharmaceutical manufacturers and research institutions developing advanced lipid-lowering therapies.

Application

• Active Pharmaceutical Ingredient (API): Primary use in the formulation of oral solid dosage forms (tablets, capsules) for cholesterol management.
• Pharmaceutical R&D: Serves as a key reference standard and starting material in the research and development of new statin-based medications and combination therapies.
• Generic Drug Manufacturing: A vital component for companies producing generic versions of pitavastatin calcium tablets following patent expirations.
• Clinical Trial Material: Used in the production of batches for pharmacokinetic, bioavailability, and Phase I-IV clinical studies.
• Analytical Standard: Employed as a high-purity standard in Quality Control laboratories for HPLC, LC-MS, and other analytical method development and validation.

Basic Information

Product Name	Pitavastatin Calcium
CAS No.	147526-32-7
Molecular Formula	C50H46CaF2N2O8•2H2O
Molecular Weight	880.98 g/mol (Dihydrate)
Synonyms	Pitavastatin Calcium Salt; 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
EINECS	Contact for details

Quality Control

Our Pitavastatin Calcium is manufactured under strict quality management systems, targeting compliance with ICH Q7 and current Good Manufacturing Practice (cGMP) guidelines for Active Pharmaceutical Ingredients (APIs). Every batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We ensure traceability and supply chain integrity to meet the stringent requirements of global pharmaceutical regulators.

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 maintain stability and potency. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm

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