Description

Adapalene Glucuronide is a key metabolite and analytical reference standard of the pharmaceutical compound adapalene. This high-purity compound is critical for pharmaceutical research, development, and quality control processes, ensuring accurate metabolic profiling and regulatory compliance. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in drug metabolism and pharmacokinetics (DMPK) studies, bioanalytical method development, and impurity characterization.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quantification and identification of adapalene metabolites in biological matrices.
• Drug Metabolism & Pharmacokinetics (DMPK): Essential for in vitro and in vivo studies to understand the metabolic pathway, clearance, and bioavailability of adapalene.
• Bioanalytical Method Development: Used as a critical standard for developing and validating robust HPLC, LC-MS, or LC-MS/MS methods in compliance with ICH guidelines.
• Impurity Profiling: Employed to identify, monitor, and control process-related impurities and degradation products in adapalene drug substance and finished product manufacturing.
• Regulatory Submissions: Provides essential data for Investigational New Drug (IND) and New Drug Application (NDA) filings to health authorities like the FDA and EMA.
• Clinical Trial Support: Used in analyzing patient samples during clinical trials to assess drug exposure and metabolic fate.

Basic Information

Product Name	Adapalene Glucuronide
CAS No.	359699-07-3
Molecular Formula	C34H39NO9
Molecular Weight	605.68 g/mol
Synonyms	Adapalene β-D-Glucuronide; 6-[3-(1-Adamantyl)-4-methoxyphenyl]-2-naphthoic acid β-D-Glucopyranosiduronic acid; CD 271 Glucuronide; Differin Glucuronide; Adapalene D-Glucuronide; Adapalene Glucuronide Metabolite; Adapalene-β-D-Glucuronide
EINECS	Contact for details

Quality Control

Our Adapalene Glucuronide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, LC-MS for identity confirmation, and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data on purity, impurities, and analytical methods.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Meets ICH limits

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