Description

Pitavastatin Impurity 29 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of Pitavastatin, a widely prescribed statin medication for managing cholesterol levels. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, impurity profiling, and ensuring drug safety. The availability of a well-characterized impurity standard is essential for meeting stringent pharmacopeial requirements and maintaining supply chain integrity for active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for identifying and quantifying related substances in Pitavastatin API and finished dosage forms.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (HPLC, UPLC) for impurity detection.
• Quality Control and Assurance (QC/QA): Essential for routine batch release testing in pharmaceutical manufacturing to ensure impurity levels are within ICH guidelines.
• Regulatory Submissions and Compliance: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to agencies like the FDA and EMA.
• Stability Studies: Employed to monitor the formation of degradation products in Pitavastatin under various stress conditions.
• Research and Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of this specific impurity.

Basic Information

Product Name	Pitavastatin Impurity 29
CAS No.	148516-15-8
Molecular Formula	C25H22FNO4
Molecular Weight	419.45 g/mol
Synonyms	Pitavastatin Related Compound 29; Pitavastatin EP Impurity J; Pitavastatin USP Impurity; (3R,5S)-7-(4-Cyclopropyl-2-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid impurity; Livalo Impurity 29; NK-104 Impurity 29; Pitavastatin Lactone Impurity; Pitavastatin Process Impurity
EINECS	Contact for details

Quality Control

Our Pitavastatin Impurity 29 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from tests including identification by spectroscopic methods (IR, NMR, MS), purity assay by HPLC, and control of related impurities and residual solvents. We adhere to ICH Q3A and Q3B guidelines for impurities in new drug substances and products, ensuring our reference standards meet the exacting requirements of global pharmacopeias and regulatory authorities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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