Description

Pitavastatin Impurity 23 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 cholesterol-lowering drug Pitavastatin. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity is essential for maintaining the stringent purity standards demanded in modern pharmaceutical production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Pitavastatin active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles during API synthesis and formulation.
• Quality Control & Assurance: Serves as a system suitability standard in routine QC labs to ensure analytical procedures remain accurate and precise for batch release.
• Regulatory Compliance & Filing: Required for preparing regulatory submission documents (e.g., for FDA, EMA) to establish impurity thresholds and control strategies as per ICH guidelines.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (light, heat, humidity) to determine drug product shelf-life.
• Process Chemistry Research: Employed by R&D scientists to study and optimize synthetic pathways to minimize the formation of this impurity.

Basic Information

Product Name	Pitavastatin Impurity 23
CAS No.	1467166-39-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pitavastatin Related Compound 23; Pitavastatin EP Impurity J; Pitavastatin USP Impurity; Pitavastatin Degradation Product; Pitavastatin Process Impurity; (3R,5S)-7-(4-Cyclopropyl-2-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid impurity; Livalo Impurity 23
EINECS	Contact for details

Quality Control

Every batch of Pitavastatin Impurity 23 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques 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 in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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