Description

Pitavastatin Impurity 60 is a high-purity chemical reference standard used in the research, development, and quality control of the cholesterol-lowering drug Pitavastatin. This compound is critical for ensuring the safety and efficacy of pharmaceutical products by enabling the accurate identification, quantification, and control of related substances during manufacturing. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical industry, particularly those involved in method validation, stability studies, and regulatory compliance for generic and innovator drug formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Pitavastatin and its related substances.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurities in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to ensure Pitavastatin batches meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity profiles.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing programs.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for ANDA, NDA) by providing characterized impurity data for health authorities like the FDA and EMA.
• Research & Development: Facilitates process chemistry research to understand impurity formation pathways and optimize synthesis routes for cleaner API production.

Basic Information

Product Name	Pitavastatin Impurity 60
CAS No.	1661064-71-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pitavastatin Related Compound 60; Pitavastatin EP Impurity J; Pitavastatin USP Impurity; Pitavastatin Process Impurity; Pitavastatin Degradant; (3R,5S)-7-(4-Cyclopropyl-2-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid impurity; Livalo Impurity 60
EINECS	Contact for details

Quality Control

Our Pitavastatin Impurity 60 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing the results against established specifications. Our quality commitment aligns with cGMP principles and supports compliance with ICH Q3A/B guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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