Description

Finasteride Carboxylic Acid Acyl-β-D-Glucuronide is a key metabolite and reference standard of the pharmaceutical compound finasteride. This compound is of critical importance for pharmaceutical research and development, particularly in the areas of drug metabolism and pharmacokinetic (DMPK) studies. It is primarily utilized by analytical laboratories, contract research organizations (CROs), and pharmaceutical companies engaged in bioanalytical method development and regulatory compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quantitative and qualitative analysis of finasteride metabolites in biological matrices.
• Drug Metabolism Studies: Essential for investigating the metabolic pathways, bioavailability, and excretion profiles of finasteride in preclinical and clinical research.
• Bioanalytical Method Development: Used as a critical standard for developing and validating sensitive LC-MS/MS or HPLC methods for pharmacokinetic assays.
• Impurity Profiling: Employed in the identification and quantification of glucuronidated metabolites as potential impurities in active pharmaceutical ingredient (API) batches.
• Toxicology and Safety Assessment: Aids in understanding the safety profile and potential drug-drug interactions related to finasteride's metabolic fate.
• Regulatory Submissions: Provides essential data to support regulatory filings (e.g., with FDA, EMA) by characterizing the drug's metabolic products.

Basic Information

Product Name	Finasteride Carboxylic Acid Acyl-β-D-Glucuronide
CAS No.	1196787-40-2
Molecular Formula	C30H43NO8
Molecular Weight	545.67 g/mol
Synonyms	Finasteride Acyl Glucuronide; Finasteride Carboxylic Acid Glucuronide; Finasteride Metabolite; 17β-(N-tert-Butylcarbamoyl)-4-aza-5α-androst-1-ene-3-carboxylic Acid Acyl-β-D-Glucuronide; 1H-Pyrrole-3-carboxylic acid, 2-[[(1,1-dimethylethyl)amino]carbonyl]-5,17-bis(1,1-dimethylethyl)-6-oxo-, (5α,17β)-, β-D-glucopyranosiduronic acid; Finasteride Glucuronide Metabolite; Finasteride-COOH Glucuronide
EINECS	Contact for details

Quality Control

Our Finasteride Carboxylic Acid Acyl-β-D-Glucuronide is manufactured under strict quality control protocols suitable for research and analytical use. Each batch is characterized using advanced spectroscopic and chromatographic techniques to ensure identity, purity, and stability. Certificates of Analysis (COA) detailing lot-specific results for assay, purity, and related substances are provided and traceable to primary reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below for long-term stability. For short-term use, the material may be stored at 2-8°C. Allow the vial to equilibrate to room temperature in a dry environment before opening to prevent condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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