Description

Pitavastatin Impurity 45 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 dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities during drug manufacturing.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure Pitavastatin batches meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Used to track and quantify the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing.
• Regulatory Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to characterize and justify impurity limits in new drug applications (NDAs) and marketing authorization dossiers.
• Research & Development: Utilized in R&D to study the degradation pathways and chemical behavior of Pitavastatin, aiding in process optimization and formulation development.

Basic Information

Product Name	Pitavastatin Impurity 45
CAS No.	1258947-29-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pitavastatin Related Compound 45; Pitavastatin EP Impurity J; Pitavastatin USP Impurity; Pitavastatin Degradant; Pitavastatin Process Impurity; (3R,5S)-7-(4-Cyclopropyl-2-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid impurity; Livalo Impurity 45
EINECS	Contact for details

Quality Control

Our Pitavastatin Impurity 45 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and traceability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced chromatographic and spectroscopic methods (e.g., HPLC, NMR, MS). We ensure compliance with relevant pharmacopeial standards and ICH Q3A/B guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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