Description

Pitavastatin Impurity 74 is a high-purity chemical reference standard used in the pharmaceutical development and manufacturing process. This compound is critical for ensuring the quality, safety, and regulatory compliance of the cholesterol-lowering drug Pitavastatin. It is primarily required by analytical laboratories and pharmaceutical companies for method development, validation, and routine quality control testing. The availability of a well-characterized impurity standard is essential for maintaining stringent pharmacopeial standards and batch-to-batch consistency.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Pitavastatin active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Used in research and development (R&D) laboratories to develop and optimize chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines and drug substance specifications.
• Regulatory Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to characterize and justify impurity limits in new drug applications (NDA/ANDA).
• Stability Studies: Used as a marker to track the formation of degradation products during forced degradation and long-term stability studies of Pitavastatin.
• Pharmacopeial Testing: Supports testing to meet the requirements of international pharmacopeias like USP, EP, and JP for Pitavastatin monographs.

Basic Information

Product Name	Pitavastatin Impurity 74
CAS No.	167934-30-7
Molecular Formula	C25H22FNO4
Molecular Weight	419.45 g/mol
Synonyms	(3R,5S)-7-(4-Cyclopropyl-2-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid; Pitavastatin Related Compound 74; Pitavastatin EP Impurity I; Pitavastatin USP Impurity; Pitavastatin Acid Form Impurity; (E)-7-[4-Cyclopropyl-2-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxyhept-6-enoic Acid; Pitavastatin δ-Lactone Impurity
EINECS	Contact for details

Quality Control

Every batch of Pitavastatin Impurity 74 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques including HPLC, GC, MS, and NMR to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming conformity to in-house specifications aligned with ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material should be kept in a cool, dry, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to prevent potential degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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