Description

Pitavastatin Defuoro Impurity Calcium Salt is a high-purity reference standard and pharmaceutical intermediate critical for quality control and research in statin drug development. This compound serves as a specified impurity for the active pharmaceutical ingredient Pitavastatin Calcium, enabling precise analytical method validation and ensuring product safety and regulatory compliance. It is essential for pharmaceutical manufacturers, analytical laboratories, and research institutions focused on cardiovascular drug development and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the defluoro impurity in Pitavastatin Calcium API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Critical for developing, calibrating, and validating chromatographic methods to monitor impurity levels during API synthesis and formulation.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure Pitavastatin drug substances and products meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity thresholds.
• Process Chemistry Research: Used to study the formation and fate of this specific impurity during the synthesis, purification, and scale-up of Pitavastatin Calcium.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies and product safety.
• Stability Studies: Helps in monitoring impurity profiles in stability samples to determine the shelf-life and storage conditions of Pitavastatin-based medications.

Basic Information

Product Name	Pitavastatin Defuoro Impurity Calcium Salt
CAS No.	1258947-30-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pitavastatin Desfluoro Impurity Calcium Salt; Pitavastatin EP Impurity F Calcium Salt; Pitavastatin Related Compound F Calcium Salt; (3R,5S)-7-(4-Cyclopropyl-2-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic Acid Calcium Salt; Pitavastatin De-Fluoro Analog Calcium Salt; Pitavastatin Impurity 6 Calcium Salt; Pitavastatin Defluoro Derivative Calcium
EINECS	Contact for details

Quality Control

Our Pitavastatin Defuoro Impurity Calcium Salt is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques, to ensure identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) with detailed chromatograms and spectral data. Our quality standards align with ICH Q3A/B guidelines and support compliance with cGMP for pharmaceutical impurities and reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
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.