Description

Pitavastatin Impurity 44 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and regulatory compliance of the cholesterol-lowering drug Pitavastatin. It is primarily utilized by analytical chemists and quality control laboratories in the pharmaceutical industry for method development, validation, and impurity profiling studies. The availability of well-characterized impurities like this is essential for meeting stringent pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Pitavastatin.
• Impurity Profiling and Identification: Essential for identifying, characterizing, and quantifying this specific impurity in active pharmaceutical ingredient (API) batches.
• Analytical Method Development and Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for purity testing.
• Quality Control and Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Used to track the formation of this impurity during forced degradation and long-term stability studies of Pitavastatin.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Supports synthetic route optimization and process chemistry research by understanding impurity formation pathways.

Basic Information

Product Name	Pitavastatin Impurity 44
CAS No.	586966-55-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pitavastatin Related Compound 44; Pitavastatin EP Impurity I; Pitavastatin USP Impurity; (3R,5S)-7-(4-Cyclopropyl-2-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid impurity; Livalo Impurity 44; NK-104 Impurity 44
EINECS	Contact for details

Quality Control

Our Pitavastatin Impurity 44 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and residual solvent analysis, to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B, USP, and EP guidelines.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
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.