Description

n-Desmethyl Diltiazem-D3 Hydrochloride is a high-purity, isotopically labeled internal standard critical for accurate quantitative analysis in bioanalytical and pharmacokinetic studies. This compound is essential for ensuring the precision and reliability of mass spectrometry-based assays, particularly in the development and monitoring of cardiovascular therapeutics. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities specializing in drug metabolism and pharmacokinetics (DMPK).

Application

• Internal Standard for LC-MS/MS: Used as a deuterated internal standard for the precise quantification of diltiazem and its metabolites in complex biological matrices like plasma, serum, and urine.
• Pharmacokinetic (PK) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical research.
• Bioanalytical Method Development & Validation: Serves as a critical reference material for developing, optimizing, and validating robust analytical methods compliant with FDA, EMA, and ICH guidelines.
• Drug Metabolism Research: Facilitates the identification and quantification of specific metabolic pathways, aiding in the understanding of drug-drug interactions and metabolite profiling.
• Therapeutic Drug Monitoring (TDM): Supports assays designed to monitor diltiazem concentrations in patient samples to ensure therapeutic efficacy and safety.
• Quality Control in Pharmaceutical Manufacturing: Employed in impurity profiling and stability testing of active pharmaceutical ingredients (APIs) and finished drug products.

Basic Information

Item	Details
Product Name	n-Desmethyl Diltiazem-D3 Hydrochloride
CAS No.	1309283-14-4
Molecular Formula	C22H23D3N2O4S • HCl
Molecular Weight	458.02 g/mol (approx.)
Synonyms	Diltiazem Desmethyl-D3 Hydrochloride; Desmethyl Diltiazem D3 HCl; Diltiazem N-Desmethyl-D3 Hydrochloride; (+)-cis-3-(Acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-1,5-benzothiazepin-4(5H)-one N-Desmethyl-D3 Hydrochloride; Diltiazem Metabolite (M1) D3 Hydrochloride; Diltiazem-d3 Derivative; Isotopically Labeled Diltiazem Internal Standard
EINECS	Contact for details

Quality Control

Every batch of n-Desmethyl Diltiazem-D3 Hydrochloride is manufactured and tested under strict quality systems to ensure exceptional purity and isotopic enrichment suitable for sensitive analytical applications. Our products undergo rigorous quality testing, including HPLC, NMR, and mass spectrometry, to ensure compliance with industry standards for reference materials. Certificates of Analysis (COA) detailing purity, isotopic purity (D-enrichment), and analytical data are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material 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 (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity (D-enrichment)	≥98.0 atom % D
Chemical Purity	≥95.0%
Water Content (KF)	≤2.0%
Residue on Ignition	≤0.5%

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