Description

Ciclopirox Glucuronide is a key metabolite and synthetic intermediate of the broad-spectrum antifungal agent ciclopirox. This compound is of significant importance in pharmaceutical research and development, particularly for metabolism studies, pharmacokinetic profiling, and the synthesis of analytical reference standards. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in drug development, bioanalytical method validation, and quality control of antifungal APIs and formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantification of ciclopirox and its metabolites in biological matrices during pharmacokinetic studies.
• Metabolite Research: Critical for in vitro and in vivo studies investigating the metabolic pathways, bioavailability, and clearance mechanisms of the parent drug ciclopirox.
• Analytical Method Development: Serves as a high-purity standard for developing and validating HPLC, LC-MS, and other chromatographic methods in quality control laboratories.
• Antifungal API Synthesis: Employed as a sophisticated intermediate or precursor in the multi-step synthesis of ciclopirox olamine and related antifungal compounds.
• Impurity Profiling: Used to identify and quantify glucuronide-related impurities in active pharmaceutical ingredient (API) batches to ensure compliance with ICH guidelines.
• Toxicology Studies: Applied in safety and toxicology assessments to understand the profile and potential effects of drug metabolites.

Basic Information

Item	Details
Product Name	Ciclopirox Glucuronide
CAS No.	79419-54-8
Molecular Formula	C18H23NO11
Molecular Weight	429.38 g/mol
Synonyms	6-[[(1-Hydroxy-4-methyl-6-cyclohexyl-2(1H)-pyridinyl)oxy]methyl]-β-D-glucopyranuronic acid; Ciclopirox β-D-Glucuronide; Ciclopirox Glucuronide Metabolite; Loprox Glucuronide; HOE 296b Glucuronide; Ciclopirox 1-O-β-D-Glucuronide; (2R,3S,4S,5R,6S)-3,4,5-Trihydroxy-6-((((1-hydroxy-4-methyl-6-cyclohexyl-2-oxo-1,2-dihydropyridin-3-yl)oxy)methoxy)tetrahydro-2H-pyran-2-carboxylic acid
EINECS	Contact for details

Quality Control

Our Ciclopirox Glucuronide is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure high purity and consistency. Quality assurance protocols align with ICH Q3A/B guidelines for impurity profiling. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing results for identity, purity (by HPLC), residual solvents, and related substances. We support cGMP compliance for advanced pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as specified on the label. This product is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
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.