Description

n-Desmethyl Diltiazem-D4 Hydrochloride is a high-purity, isotopically labeled internal standard critical for advanced analytical applications. This compound is essential for ensuring the accuracy and reliability of quantitative bioanalytical methods, particularly in pharmacokinetic and metabolic studies. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory testing facilities for precise mass spectrometry-based assays.

Application

• Primary use as an internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the quantification of diltiazem and its metabolites.
• Critical component in pharmacokinetic studies to determine drug absorption, distribution, metabolism, and excretion (ADME) profiles.
• Enabling technology for bioequivalence and clinical trial analysis, ensuring data integrity for regulatory submissions.
• Supporting forensic and anti-doping analysis where precise identification and quantification of substances are required.
• Utilized in metabolite profiling and identification research to understand drug biotransformation pathways.
• Essential for method development and validation in analytical laboratories to meet GLP and GMP standards.

Basic Information

Product Name	n-Desmethyl Diltiazem-D4 Hydrochloride
CAS No.	1217650-51-5
Molecular Formula	C21H21D4N2O4S • HCl
Molecular Weight	457.02 g/mol (approx.)
Synonyms	Desmethyldiltiazem-D4 HCl; Diltiazem Metabolite M1-D4 Hydrochloride; (+)-cis-3-(Acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-1,5-benzothiazepin-4(5H)-one N-Desmethyl-D4 Hydrochloride; 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, (2S,3S)-, N-Desmethyl-D4 Hydrochloride; Diltiazem-d4 Metabolite Standard; Isotopically Labeled Diltiazem Metabolite.
EINECS	Contact for details

Quality Control

Our n-Desmethyl Diltiazem-D4 Hydrochloride is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for sensitive analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing results from advanced characterization techniques including NMR, HPLC, and MS. We ensure compliance with the rigorous standards expected in pharmaceutical research and development.

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. For long-term storage, consider desiccated conditions.

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 (D-enrichment)	≥ 98.0 atom % D
Chemical Purity (NMR)	Conforms
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.