Description

Diphenhydramine n-β-D-Glucuronide is a major, pharmacologically relevant metabolite of the antihistamine diphenhydramine, formed via glucuronidation. This compound is essential for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics (PK), and bioanalytical method validation. It serves as a critical reference standard for scientists and quality control laboratories in the pharmaceutical, biotechnology, and contract research organization (CRO) sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for quantitative and qualitative analysis.
• Metabolite Identification & Profiling: Crucial for in vitro and in vivo ADME (Absorption, Distribution, Metabolism, Excretion) studies to understand drug clearance pathways.
• Bioanalytical Method Development: Used as a standard to develop and validate sensitive HPLC-MS/MS or LC-UV methods for biological sample analysis.
• Pharmacokinetic (PK) Studies: Enables accurate measurement of metabolite levels in plasma, serum, or urine to determine PK parameters.
• Drug Safety & Toxicology: Supports investigations into the safety profile and potential activity of drug metabolites.
• Quality Control & Assurance: Ensures the accuracy and reliability of analytical testing within GMP and GLP environments.

Basic Information

Product Name	Diphenhydramine n-β-D-Glucuronide
CAS No.	137908-78-2
Molecular Formula	C25H31NO7
Molecular Weight	457.52 g/mol
Synonyms	Diphenhydramine N-Glucuronide; Diphenhydramine Glucuronide; N-(4-Methoxybenzyl)-N,N-dimethyl-2-[(phenylamino)methyl]-1-O-β-D-glucopyranuronosyl-1H-imidazol-3-ium-5-olate; Benzhydryl β-D-Glucopyranosiduronic Acid Derivative; Diphenhydramine Major Metabolite; DHM-Glucuronide
EINECS	Contact for details

Quality Control

Our Diphenhydramine n-β-D-Glucuronide is manufactured and handled under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. A detailed Certificate of Analysis (COA) is provided, containing batch-specific data on purity, identity, and impurities. We support compliance with GMP/GLP guidelines for reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a freezer. This product is hygroscopic (moisture-sensitive) and should be allowed to equilibrate to room temperature in a dry environment before opening to prevent condensation and moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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