Description

8-Hydroxy Pitavastatin is a key pharmaceutical intermediate and metabolite of the cholesterol-lowering drug Pitavastatin. This compound is of significant importance for research and development in the pharmaceutical industry, particularly in the study of drug metabolism, pharmacokinetics, and the synthesis of novel active pharmaceutical ingredients (APIs). It is primarily utilized by pharmaceutical manufacturers, research institutions, and contract development and manufacturing organizations (CDMOs) engaged in cardiovascular drug development and analytical method validation.

Application

• Pharmaceutical Intermediate: A critical building block in the synthesis and research of Pitavastatin and its analogs.
• Metabolite Reference Standard: Used as an analytical standard in bioanalytical studies to understand the metabolic profile and pharmacokinetics of Pitavastatin.
• Research & Development: Essential for academic and industrial R&D focused on HMG-CoA reductase inhibitors and cardiovascular therapeutics.
• Quality Control & Analytical Testing: Serves as a high-purity reference material for HPLC, LC-MS, and other analytical methods to ensure drug purity and consistency.
• Process Chemistry: Employed in the development and optimization of synthetic routes for statin-class APIs.

Basic Information

Product Name	8-Hydroxy Pitavastatin
CAS No.	224320-09-6
Molecular Formula	C₂₅H₂₀FNO₄
Molecular Weight	417.43 g/mol
Synonyms	8-Hydroxypitavastatin; Pitavastatin 8-Hydroxy Metabolite; (3R,5S)-7-(2-Cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic Acid (8-Hydroxy); NK-104 8-Hydroxy Metabolite; Livalo® Metabolite; Itavastatin 8-Hydroxy Derivative
EINECS	Contact for details

Quality Control

Our 8-Hydroxy Pitavastatin is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by IR and MS, and residual solvent analysis, to ensure it meets high-grade standards suitable for pharmaceutical research. A detailed Certificate of Analysis (COA) is provided with every shipment, guaranteeing traceability and compliance with your specifications.

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 powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Single Maximum Unknown Impurity	≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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