Description

n-Desmethyl Diphenhydramine Hydrochloride is a key pharmaceutical intermediate and metabolite of the widely used antihistamine diphenhydramine. This compound is of significant importance for research, development, and quality control within the pharmaceutical and analytical chemistry sectors. It is primarily required by manufacturers and research institutions engaged in pharmacokinetic studies, impurity profiling, and the synthesis of advanced drug substances.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantification and identification of diphenhydramine and its metabolites in drug testing and bioanalytical studies.
• Active Pharmaceutical Ingredient (API) Intermediate: Serves as a critical building block in the synthesis of novel pharmaceutical compounds and derivatives.
• Metabolite Research: Essential for in vitro and in vivo studies investigating the metabolic pathways, pharmacokinetics, and pharmacodynamics of diphenhydramine.
• Impurity Standard: Employed in HPLC and LC-MS methods to identify, quantify, and control process-related impurities in diphenhydramine API batches to ensure compliance with ICH guidelines.
• Forensic and Clinical Toxicology: Used as an analytical standard in forensic labs and hospitals for accurate drug screening and confirmation.
• Academic and R&D Laboratories: Utilized in chemical and pharmacological research to study structure-activity relationships and develop new analytical methodologies.

Basic Information

Product Name	n-Desmethyl Diphenhydramine Hydrochloride
CAS No.	53499-40-4
Molecular Formula	C16H20ClNO
Molecular Weight	277.79 g/mol
Synonyms	Nor-Diphenhydramine Hydrochloride; Desmethyldiphenhydramine HCl; 2-(Benzhydryloxy)-N-methylethanamine Hydrochloride; N-Methyl-2-(diphenylmethoxy)ethanamine Hydrochloride; Diphenhydramine Impurity C (Hydrochloride); Diphenhydramine Metabolite; DPH-DM HCl
EINECS	Contact for details

Quality Control

Our n-Desmethyl Diphenhydramine Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by IR and NMR, and residual solvent analysis, to ensure it meets high-purity standards suitable for pharmaceutical research. Certificates of Analysis (COA) with detailed chromatographic data are provided to guarantee traceability and batch-to-batch consistency.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The material is hygroscopic (moisture-sensitive); ensure the container is kept tightly sealed in a dry environment.

Specification

Item	Specification
Appearance	White to off-white crystalline 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%
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%

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