Description

Pitavastatin Impurity 25 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 process-related impurities. It is an essential material for analytical laboratories and pharmaceutical manufacturers engaged in method validation, stability studies, and regulatory compliance for Pitavastatin API and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Pitavastatin Impurity 25 in active pharmaceutical ingredients (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods to monitor impurities in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Pitavastatin drug substances and products meet stringent purity specifications.
• Stability Studies: Employed to track the formation of this specific impurity over time under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity profiles for Drug Master Files (DMFs) and New Drug Applications (NDAs).
• Process Chemistry Research: Aids chemists in understanding and optimizing the Pitavastatin synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Pitavastatin Impurity 25
CAS No.	1356998-79-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pitavastatin Related Compound 25; Pitavastatin EP Impurity I; Pitavastatin USP Impurity; (3R,5S)-7-(4-Cyclopropyl-2-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid impurity; Livalo Impurity 25; NK-104 Impurity 25
EINECS	Contact for details

Quality Control

Every batch of Pitavastatin Impurity 25 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as 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, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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