Description

Pitavastatin Impurity 18 Sodium Salt is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound is essential for the identification, quantification, and control of related substances during the manufacturing and quality assurance of Pitavastatin, a widely used cholesterol-lowering medication. It is primarily utilized by analytical laboratories, quality control units, and regulatory affairs departments within the pharmaceutical and fine chemical industries to ensure drug safety, efficacy, and compliance with stringent global regulatory standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Pitavastatin API and finished dosage forms.
• Analytical Research: Used in HPLC, LC-MS, and other chromatographic studies for the precise identification and quantification of Pitavastatin Impurity 18 in drug substances and products.
• Regulatory Compliance & Documentation: Critical for preparing regulatory submission dossiers (e.g., for FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions, supporting shelf-life determination.
• Process Chemistry & Optimization: Aids chemists in identifying and minimizing the formation of this impurity during the synthesis and purification stages of Pitavastatin manufacturing.
• Pharmacopoeial Testing: Supports testing in compliance with pharmacopoeial monographs (e.g., USP, EP, JP) that specify limits for known and unknown impurities.

Basic Information

Product Name	Pitavastatin Impurity 18 Sodium Salt
CAS No.	1611499-16-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pitavastatin Related Compound 18 Sodium Salt; Pitavastatin EP Impurity H Sodium Salt; Pitavastatin USP Impurity Sodium Salt; (3R,5S)-7-(2-Cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid impurity sodium salt; Sodium (E)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoate related substance; Livalo Impurity 18 Sodium Salt; NK-104 Impurity 18 Sodium Salt
EINECS	Contact for details

Quality Control

Every batch of Pitavastatin Impurity 18 Sodium Salt is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, NMR, and MS to ensure compliance with industry standards and customer specifications. A comprehensive Certificate of Analysis (COA), detailing all test results and methods, is provided with each shipment to support your regulatory and quality requirements.

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 dry, inert conditions to maintain stability and purity. For long-term storage, consider desiccants or an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH guidelines

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