Description

Pitavastatin 5-Oxo Impurity Calcium Salt is a high-purity reference standard and impurity used in the pharmaceutical development and quality control of Pitavastatin, a critical statin medication. This compound is essential for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in API synthesis, method validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the calibration of analytical instruments and validation of testing methods in compliance with ICH guidelines.
• Impurity Profiling & Control: Critical for identifying, monitoring, and quantifying the 5-oxo impurity during the synthesis and purification of Pitavastatin Active Pharmaceutical Ingredient (API).
• Method Development & Validation: Serves as a key component in developing and validating HPLC, UPLC, or LC-MS methods for related substance analysis in drug substances and products.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability protocols.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications for drug approval.
• Quality Assurance/Quality Control (QA/QC): Integral for routine batch release testing of Pitavastatin API to ensure it meets stringent pharmacopeial (USP, EP) purity requirements.

Basic Information

Product Name	Pitavastatin 5-Oxo Impurity Calcium Salt
CAS No.	2180095-22-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pitavastatin 5-Keto Impurity Calcium Salt; Pitavastatin EP Impurity F Calcium Salt; (3R,5S)-7-(2-Cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyheptanoic acid 5-oxo calcium salt; Calcium (3R,5S)-3,5-dihydroxy-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]heptanoate 5-one; Pitavastatin Related Compound F Calcium Salt; Livalo Impurity Calcium Salt; NK-104 Impurity Calcium Salt
EINECS	Contact for details

Quality Control

Our Pitavastatin 5-Oxo Impurity Calcium Salt is manufactured under strict quality systems suitable for pharmaceutical analysis. Each batch undergoes comprehensive testing, including identification, assay, and related substance analysis via validated chromatographic methods (HPLC). We provide full traceability and Certificates of Analysis (COA) that detail all testing results, ensuring compliance with relevant pharmacopeial standards and ICH Q3A/B guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Single Unknown Impurity	≤ 1.0%
Total Impurities	≤ 2.0%
Water Content (KF)	≤ 5.0%

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