Description

N,n-Didesmethyl Diltiazem-D4 Hydrochloride is a high-purity, isotopically labeled internal standard critical for advanced analytical applications. This deuterated compound is essential for ensuring the accuracy and reliability of quantitative bioanalytical methods, particularly in pharmacokinetic and metabolism studies. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities requiring precise and interference-free quantification of diltiazem and its metabolites.

Application

• Internal Standard for LC-MS/MS Analysis: Serves as a critical reference compound for the accurate quantification of diltiazem and its metabolites in complex biological matrices like plasma, serum, and urine.
• Pharmacokinetic (PK) and Bioequivalence Studies: Enables precise tracking of drug concentration over time, supporting drug development and regulatory submissions.
• Drug Metabolism and Disposition Research: Used in ADME (Absorption, Distribution, Metabolism, Excretion) studies to investigate metabolic pathways and identify metabolites.
• Forensic and Clinical Toxicology: Provides a reliable standard for the confirmatory analysis of diltiazem in forensic investigations or therapeutic drug monitoring.
• Method Development and Validation: A key component in developing, optimizing, and validating robust, GLP-compliant analytical methods.
• Quality Control in Pharmaceutical Manufacturing: Supports impurity profiling and stability testing of diltiazem-based drug substances and products.

Basic Information

Product Name	N,n-Didesmethyl Diltiazem-D4 Hydrochloride
CAS No.	1246819-75-9
Molecular Formula	C22H22D4N2O4S • HCl
Molecular Weight	467.02 g/mol (approx.)
Synonyms	Didesmethyl Diltiazem-d4 HCl; 5-[2-(Dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-4-methyl-1,5-benzothiazepin-3-ol-2,2,3,3-d4 Hydrochloride; Diltiazem Impurity D4 Hydrochloride; Diltiazem Metabolite M4-D4 HCl; (+)-cis-3-Acetoxy-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-1,5-benzothiazepin-4(5H)-one Desmethyl-D4 Hydrochloride; Deuteronated Didesmethyl Diltiazem HCl
EINECS	Contact for details

Quality Control

Every batch of N,n-Didesmethyl Diltiazem-D4 Hydrochloride is manufactured and analyzed under strict quality systems. We guarantee high chemical and isotopic purity to meet the exacting standards of analytical research. A comprehensive Certificate of Analysis (COA), detailing results for assay, isotopic enrichment, and impurity profiles (typically by HPLC and NMR), is provided with each shipment to ensure full traceability and compliance with your method requirements.

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 and purity. Keep the container tightly sealed after each use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Enrichment	≥ 98 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.