Description

Pitavastatin Impurity 18 Sodium Salt 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 quality control testing. The availability of this well-characterized impurity standard is essential for maintaining stringent pharmacopeial standards in pharmaceutical production.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Pitavastatin Impurity 18 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Used in HPLC, UPLC, and LC-MS methods to establish retention times, calibration curves, and detection limits for this specific impurity.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing of Pitavastatin to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Pitavastatin.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Research & Development: Utilized in synthetic chemistry research to study the formation, isolation, and characterization of process-related impurities.

Basic Information

Product Name	Pitavastatin Impurity 18 Sodium Salt
CAS No.	2276678-27-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pitavastatin Related Compound 18 Sodium Salt; Pitavastatin EP Impurity 18 Sodium Salt; Pitavastatin USP Impurity 18 Sodium Salt; Pitavastatin Sodium Salt Impurity 18; (3R,5S)-7-(4-Cyclopropyl-2-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid sodium salt impurity; Pitavastatin Degradation Product 18 Sodium Salt; Pitavastatin Process Impurity 18 Sodium Salt
EINECS	Contact for details

Quality Control

Our Pitavastatin Impurity 18 Sodium Salt is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and spectroscopic methods for structural confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment. Our quality commitment aligns with the principles of cGMP and relevant ICH guidelines for impurities in new drug substances.

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. The container should be stored in a desiccator or under an inert atmosphere after opening.

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

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