Description

Pitavastatin Impurity 19 Sodium Salt 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 impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Pitavastatin active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurity levels during manufacturing.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure batch-to-batch consistency and compliance with pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation of degradation products in Pitavastatin formulations under various stress conditions.
• Regulatory Submissions: Essential for preparing impurity identification reports and documentation required for regulatory filings with agencies like the FDA and EMA.
• Research & Development: Utilized in metabolic studies and research to understand the degradation pathways and chemistry of Pitavastatin.

Basic Information

Product Name	Pitavastatin Impurity 19 Sodium Salt
CAS No.	1980814-87-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pitavastatin Related Compound 19 Sodium Salt; Pitavastatin EP Impurity 19 Sodium Salt; Pitavastatin USP Impurity 19 Sodium Salt; Sodium Pitavastatin Impurity 19; Pitavastatin Sodium Salt Impurity 19; (3R,5S)-7-(4-Cyclopropyl-2-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoate Sodium Salt Impurity; Livalo Impurity 19 Sodium Salt
EINECS	Contact for details

Quality Control

Our Pitavastatin Impurity 19 Sodium Salt is manufactured under strict quality systems to meet the exacting standards of pharmaceutical impurity analysis. Each batch undergoes comprehensive testing, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity determination by advanced chromatographic techniques (HPLC, UPLC). A comprehensive Certificate of Analysis (COA) is provided, detailing the results against stringent in-house specifications aligned with ICH guidelines. We support compliance with cGMP and major pharmacopeial requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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