Description

Diltiazem-D4 Hydrochloride is a high-purity, isotopically labeled internal standard essential for accurate quantitative analysis in complex biological matrices. Its core value lies in providing unmatched precision and reliability for pharmacokinetic and metabolic studies, ensuring data integrity in regulated environments. This compound is critically needed by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers specializing in bioanalytical method development and validation.

Application

• Bioanalytical Method Development: Serves as a critical internal standard in LC-MS/MS and HPLC methods for quantifying Diltiazem and its metabolites in plasma, serum, and urine.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Metabolite Identification and Profiling: Used as a reference standard to identify and characterize deuterated and non-deuterated metabolites.
• Doping Control and Forensic Analysis: Provides definitive quantification in sports anti-doping testing and forensic toxicology investigations.
• Quality Control in Pharmaceutical Manufacturing: Supports impurity profiling and assay validation for Diltiazem hydrochloride active pharmaceutical ingredient (API) and finished dosage forms.
• Stability-Indicating Methods: Integral to developing and validating methods that assess drug stability under various stress conditions.

Basic Information

Product Name	Diltiazem-D4 Hydrochloride
CAS No.	1217769-52-2
Molecular Formula	C22H22D4N2O4S · HCl
Molecular Weight	451.02 g/mol (approx.)
Synonyms	(2S,3S)-5-[2-(Dimethylamino)ethyl]-2-(4-methoxyphenyl)-4-oxo-2,3,4,5-tetrahydro-1,5-benzothiazepin-3-yl acetate-D4 hydrochloride; (+)-cis-3-Acetoxy-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-1,5-benzothiazepin-4(5H)-one-D4 hydrochloride; Diltiazem-d4 HCl; Deuterated Diltiazem Hydrochloride; Diltiazem Internal Standard
EINECS	Contact for details

Quality Control

Every batch of Diltiazem-D4 Hydrochloride is manufactured and analyzed under strict quality management systems. We guarantee high chemical and isotopic purity, with comprehensive testing including assay, isotopic enrichment, and identification by spectroscopic methods. A detailed Certificate of Analysis (COA), providing batch-specific data from validated analytical methods (HPLC, NMR, MS), is supplied with each shipment to ensure traceability and compliance with your laboratory's quality standards.

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 material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (MS)	≥ 98.0 atom % D
Chemical Purity (Titration)	97.0% - 103.0%
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.