Description

Diphenhydramine-D 5 Hydrochloride is a stable isotope-labeled analog of the widely used antihistamine, diphenhydramine hydrochloride. This deuterated compound is essential as an internal standard in quantitative bioanalytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and metabolic studies. It is a critical tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and forensic toxicology units engaged in drug development and clinical research.

Application

• Bioanalytical Internal Standard: Primary use as a reference standard in LC-MS/MS and GC-MS methods for quantifying diphenhydramine in biological matrices (plasma, serum, urine).
• Pharmacokinetic & Metabolism Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Forensic Toxicology: Used in confirmatory testing and accurate quantification of diphenhydramine in forensic casework and workplace drug testing.
• Drug Impurity Profiling: Assists in the identification and quantification of related substances and degradation products during drug substance and product development.
• Method Development & Validation: Critical for developing, optimizing, and validating robust analytical methods in compliance with GLP and FDA/EMA guidelines.
• Stable Isotope Dilution Assays: Provides superior accuracy by correcting for analyte loss during sample preparation and matrix effects during instrumental analysis.

Basic Information

Product Name	Diphenhydramine-D 5 Hydrochloride
CAS No.	1219795-16-0
Molecular Formula	C17H16D5NO•HCl
Molecular Weight	Contact for details
Synonyms	2-(Diphenylmethoxy)-N,N-dimethylethanamine-D5 Hydrochloride; 2-(Benzhydryloxy)-N,N-dimethylethylamine-D5 Hydrochloride; DPH-D5 HCl; [2H5]-Diphenhydramine Hydrochloride; Deuteronated Diphenhydramine HCl; Benadryl-D5 Hydrochloride (labeled); (2-Diphenylmethoxy-ethyl)-dimethyl-amine-D5 hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Diphenhydramine-D 5 Hydrochloride is manufactured and tested to meet the stringent requirements for certified reference materials. Our quality assurance includes comprehensive analytical characterization using NMR, MS, and HPLC to confirm isotopic enrichment, chemical purity, and structural identity. Certificates of Analysis (COA) are provided with each shipment, detailing batch-specific results for purity, isotopic purity, and residual solvents, ensuring full traceability and compliance with relevant pharmacopeial standards for reference materials.

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.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity	≥ 98.0 atom % D
Chemical Purity	≥ 95.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 1.0%

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