Description

Pitavastatin Methanamine Salt is a high-purity pharmaceutical intermediate and reference standard, specifically the methanamine salt form of the potent HMG-CoA reductase inhibitor pitavastatin. This compound is critical for ensuring the quality, consistency, and regulatory compliance of finished pharmaceutical products. It is primarily utilized by research institutions, analytical laboratories, and pharmaceutical manufacturers engaged in the development, quality control, and production of cholesterol-lowering medications.

Application

• Pharmaceutical Active Ingredient (API) Synthesis: Serves as a key intermediate or starting material in the manufacturing process of Pitavastatin calcium, the active form used in finished dosage forms.
• Analytical Reference Standard: Used as a certified reference material (CRM) in HPLC, LC-MS, and other chromatographic methods for the quantitative and qualitative analysis of pitavastatin in drug substances and products.
• Pharmacological Research: Employed in preclinical and clinical studies to investigate the pharmacokinetics, metabolism, and efficacy of pitavastatin and its salt forms.
• Quality Control & Assurance (QC/QA): Essential for method development, validation, and routine testing in pharmaceutical QC laboratories to verify identity, purity, and potency.
• Impurity Profiling: Used to identify and quantify related substances and degradation products during stability studies and regulatory submissions.
• Regulatory Compliance: Supports documentation for regulatory filings with agencies such as the FDA, EMA, and PMDA, requiring well-characterized reference standards.

Basic Information

Product Name	Pitavastatin Methanamine Salt
CAS No.	957137-30-3
Molecular Formula	C₂₅H₂₈FNO₄ • CH₅N
Molecular Weight	463.53 g/mol (Free base: 421.49)
Synonyms	Pitavastatin Methylamine Salt; (3R,5S,6E)-7-[2-Cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxyhept-6-enoic acid methylamine salt; NK-104 Methylamine Salt; Livalo® Intermediate; Itavastatin Methanamine Salt; Pivavastatin Methylamine Salt
EINECS	Contact for details

Quality Control

Our Pitavastatin Methanamine Salt is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for assay and purity, identification by spectroscopic methods (IR, NMR), and control of specified impurities. We provide a detailed Certificate of Analysis (COA) with each shipment, ensuring traceability and compliance with current industry and regulatory expectations for pharmaceutical intermediates and reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a low-humidity environment to maintain stability and prevent degradation.

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)	≥98.0%
Related Substances (HPLC)	Total impurities ≤2.0% Any single unknown impurity ≤0.5%
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.