Description

Diltiazem-D3 Hydrochloride is a high-purity, isotopically labeled internal standard essential for accurate quantitative analysis in bioanalytical and pharmacokinetic studies. This deuterated compound is critical for ensuring method reliability and data integrity in regulated research environments. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers specializing in mass spectrometry.

Application

• Internal Standard for LC-MS/MS: Serves as a critical reference compound for the precise quantification of Diltiazem and its metabolites in biological matrices such as plasma, serum, and urine.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical research.
• Bioanalytical Method Development and Validation: Used to develop, optimize, and validate robust analytical methods compliant with FDA, EMA, and ICH guidelines.
• Therapeutic Drug Monitoring (TDM): Facilitates the accurate measurement of Diltiazem concentrations in patient samples to optimize dosage and ensure therapeutic efficacy.
• Pharmaceutical Impurity Profiling: Aids in the identification and quantification of related substances and degradation products in drug substance and product analysis.
• Isotope Dilution Mass Spectrometry (IDMS): Employed in high-accuracy analytical techniques for definitive method development in reference laboratories.

Basic Information

Product Name	Diltiazem-D3 Hydrochloride
CAS No.	1217623-80-7
Molecular Formula	C22H23D3N2O4S • HCl
Molecular Weight	458.01 g/mol (approx.)
Synonyms	(+)-cis-3-(Acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-1,5-benzothiazepin-4(5H)-one-d3 Hydrochloride; Diltiazem-d3 HCl; Diltiazem (phenyl-d3) Hydrochloride; 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, hydrochloride, (2S,3S)-d3; Diltiazem-d3 (hydrochloride); D3-Diltiazem Hydrochloride
EINECS	Contact for details

Quality Control

Our Diltiazem-D3 Hydrochloride is manufactured under strict quality control protocols 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 parameters such as isotopic purity (atom % D), chemical purity (by HPLC), and identification. We adhere to industry best practices to support research compliant with GMP/GLP principles.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). 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	≥99.0 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.