Description

Pitavastatin Impurity 13 (Pitavastatin 2,4,6-Triene Impurity) is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Pitavastatin, a widely prescribed statin. It is an essential tool for pharmaceutical manufacturers, quality control (QC) laboratories, and research institutions involved in method development, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material to identify, quantify, and monitor this specific degradation product in Pitavastatin API and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Stability Studies and Forced Degradation Testing: Employed to understand the degradation pathways of Pitavastatin and to establish appropriate shelf-life and storage conditions.
• Quality Control and Batch Release Testing: Essential for routine QC testing to ensure that Pitavastatin batches meet stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Regulatory Documentation and Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research and Development: Used in academic and industrial R&D to study the chemical behavior, synthesis pathways, and toxicological profile of Pitavastatin-related substances.

Basic Information

Product Name	Pitavastatin Impurity 13 (Pitavastatin 2,4,6-Triene Impurity)
CAS No.	2086271-67-0
Molecular Formula	C25H22FNO4
Molecular Weight	419.45 g/mol
Synonyms	Pitavastatin 2,4,6-Triene; Pitavastatin Related Compound 13; (3R,5S)-7-(4-Cyclopropyl-2-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhepta-2,4,6-trienoic acid; Livalo Impurity 13; NK-104 Impurity 13; Pitavastatin Degradation Impurity; Pitavastatin Triene Impurity
EINECS	Contact for details

Quality Control

Every batch of Pitavastatin Impurity 13 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with the needs of cGMP-compliant environments.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature, ideally between 15-25°C (59-77°F). This compound is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 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.