Description

Pitavastatin Impurity 8 (CAS No. 1044518-75-3) is a high-purity chemical reference standard critical for analytical research and quality control in pharmaceutical development. This compound serves as a specified impurity for the cholesterol-lowering drug Pitavastatin, enabling precise monitoring and control during API synthesis and formulation. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing, ensuring product safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Pitavastatin Impurity 8 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, and LC-MS methods for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Critical for routine QC testing to ensure impurity levels in commercial batches of Pitavastatin are within specified regulatory limits.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to regulatory bodies like the FDA and EMA.
• Process Chemistry Research: Used by process chemists to understand and mitigate the formation of this impurity during the synthesis and purification stages of Pitavastatin manufacturing.

Basic Information

Product Name	Pitavastatin Impurity 8
CAS No.	1044518-75-3
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 8; (E)-7-[4-Cyclopropyl-2-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxyhept-6-enoic Acid; Livalo Impurity 8; NK-104 Impurity 8
EINECS	Contact for details

Quality Control

Every batch of Pitavastatin Impurity 8 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH guidelines and can supply materials suitable for regulatory filings.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C in a dry, cool place. This material is hygroscopic (moisture-sensitive) and light-sensitive. For long-term storage, consider storing under an inert atmosphere or with desiccant to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
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.