Description

Pitavastatin Impurity 21 is a designated chemical reference standard used in the analytical profiling and quality control of the cholesterol-lowering pharmaceutical, Pitavastatin. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Pitavastatin API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC or UPLC methods to monitor impurity levels throughout the drug's shelf life.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and a calibrant in routine quality control testing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Stability Studies: Employed in forced degradation and long-term stability studies to identify and track the formation of this impurity under various stress conditions.
• Research & Development: Used in pharmaceutical R&D to understand the degradation pathways and chemistry of Pitavastatin.

Basic Information

Product Name	Pitavastatin Impurity 21
CAS No.	164576-45-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pitavastatin Related Compound 21; 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 21; NK-104 Impurity 21; Pitavastatin Lactone Impurity; Pitavastatin Degradation Product
EINECS	Contact for details

Quality Control

Our Pitavastatin Impurity 21 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and compliance with ICH Q3A, Q3B, and relevant pharmacopeial guidelines.

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 desiccants or inert atmosphere.

Specification

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

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