Description

Pitavastatin Impurity 16 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the identification, quantification, and control of process-related impurities during the manufacturing and quality assurance of Pitavastatin, a widely prescribed statin medication. It is an essential material for analytical chemists and quality control laboratories in the pharmaceutical industry, ensuring drug safety and regulatory compliance.

Application

• Primary use as a certified reference standard for analytical method development and validation.
• Identification and quantification of impurities in Pitavastatin Active Pharmaceutical Ingredient (API) batches.
• Critical component in stability studies and forced degradation studies to understand drug product profiles.
• Used in quality control (QC) and quality assurance (QA) testing to meet ICH, USP, and EP guidelines.
• Supports regulatory filings (e.g., ANDA, NDA) by providing impurity characterization data.
• Essential for pharmaceutical research aimed at process optimization and impurity synthesis pathway studies.

Basic Information

Product Name	Pitavastatin Impurity 16
CAS No.	160495-72-7
Molecular Formula	C25H22FNO4
Molecular Weight	419.45 g/mol
Synonyms	(3R,5S)-7-(4-Cyclopropyl-2-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid; Pitavastatin Quinoline Impurity; Pitavastatin Related Compound 16; (E)-7-[4-Cyclopropyl-2-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxyhept-6-enoic Acid; Livalo Impurity 16; NK-104 Impurity 16
EINECS	Contact for details

Quality Control

Our Pitavastatin Impurity 16 is manufactured under strict quality systems to ensure the highest standards of purity and consistency. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results from advanced analytical techniques including HPLC, NMR, and MS. We ensure compliance with relevant ICH Q3A/B guidelines for impurities in new drug substances and products.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual 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.