Description

Pitavastatin Impurity 4 (Pp-4) is a high-purity reference standard used in the analytical profiling and quality control of the cholesterol-lowering drug Pitavastatin. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient by enabling the accurate identification and quantification of related substances. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and regulatory compliance teams focused on method development and validation.

Application

• Primary use as a certified reference standard for the analytical testing of Pitavastatin API and finished dosage forms.
• Critical component in method development and validation for HPLC, UPLC, and LC-MS impurity profiling.
• Used in stability studies to monitor degradation pathways and establish impurity limits.
• Essential for pharmaceutical quality control (QC) laboratories to ensure batch-to-batch consistency.
• Supports regulatory submissions (e.g., for FDA, EMA) by providing impurity data for drug master files.
• Valuable for research and development into the synthesis, metabolism, and degradation chemistry of Pitavastatin.

Basic Information

Product Name	Pitavastatin Impurity 4 (Pp-4)
CAS No.	1422058-54-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pitavastatin Related Compound 4; Pitavastatin EP Impurity 4; Pitavastatin USP Impurity 4; Pitavastatin Impurity Pp-4; (3R,5S)-7-(4-Cyclopropyl-2-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid impurity; Livalo Impurity 4; NK-104 Impurity 4
EINECS	Contact for details

Quality Control

Every batch of Pitavastatin Impurity 4 (Pp-4) is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity determination and structural confirmation (NMR, MS), to ensure compliance with pharmacopeial standards for reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
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.