Description

Pitavastatin Impurity 24 Sodium Salt is a high-purity chemical reference standard essential for pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of Pitavastatin, a widely used statin medication for managing cholesterol levels. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method development, validation, and impurity profiling to ensure drug safety and efficacy.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for identifying and quantifying 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 in quality control laboratories.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) by providing impurity identification and characterization data.
• Stability Studies: Employed in forced degradation and long-term stability studies of Pitavastatin to monitor impurity formation over time.
• Chemical Research: Used as a building block or intermediate in synthetic chemistry research related to statin analogs and metabolites.
• Quality Assurance/Quality Control (QA/QC): Acts as a system suitability standard and for routine batch release testing of Pitavastatin to ensure it meets pharmacopeial specifications.

Basic Information

Item	Details
Product Name	Pitavastatin Impurity 24 Sodium Salt
CAS No.	1980814-90-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pitavastatin Related Compound 24 Sodium Salt; Pitavastatin EP Impurity 24 Sodium Salt; Pitavastatin USP Impurity 24 Sodium Salt; Sodium (3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoate; (3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid sodium salt; Pitavastatin Sodium Impurity 24; Livalo Impurity 24 Sodium Salt
EINECS	Contact for details

Quality Control

Our Pitavastatin Impurity 24 Sodium Salt is manufactured under strict quality systems to ensure it meets the exacting standards for pharmaceutical reference materials. Each batch undergoes comprehensive analytical testing, including HPLC purity analysis, spectroscopic identification (IR, NMR, MS), and residual solvent screening. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and confirming compliance with specified standards.

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 product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
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.