Description

(+)-cis-Diltiazem-D3 Hcl (Acetoxy-D3) is a high-purity, deuterium-labeled internal standard critical for quantitative bioanalytical method development and validation. This stable isotope-labeled compound is essential for ensuring accuracy and precision in pharmacokinetic and metabolism studies, particularly for the cardiovascular drug diltiazem. It is primarily used by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in drug development and regulatory compliance work.

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 measurement of drug concentration-time profiles, supporting bioavailability and bioequivalence assessments for generic drug applications.
• Drug Metabolism and Disposition Research: Used in ADME (Absorption, Distribution, Metabolism, Excretion) studies to track and quantify parent drug and metabolite levels with high specificity.
• Clinical Trial Support: Provides reliable data for therapeutic drug monitoring and dose-response analysis during clinical phases of drug development.
• Method Development and Validation: A key component in developing robust, sensitive, and selective analytical methods compliant with FDA, EMA, and ICH guidelines.
• Quality Control in Reference Material Production: Used in the calibration and verification of certified reference materials for diltiazem.

Basic Information

Product Name	(+)-cis-Diltiazem-D3 Hcl (Acetoxy-D3)
CAS No.	1217860-13-3
Molecular Formula	C22H23D3N2O4S • HCl
Molecular Weight	457.02 g/mol
Synonyms	(2S,3S)-5-[2-(Dimethylamino)ethyl]-2-(4-methoxyphenyl)-4-oxo-2,3,4,5-tetrahydro-1,5-benzothiazepin-3-yl acetate-2H3 hydrochloride; Diltiazem-d3 (acetoxy) hydrochloride; Diltiazem Internal Standard-d3; cis-(+)-Diltiazem-d3 HCl; 3-(Acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-1,5-benzothiazepin-4(5H)-one-d3 hydrochloride
EINECS	Contact for details

Quality Control

Our (+)-cis-Diltiazem-D3 Hcl (Acetoxy-D3) is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for sensitive analytical applications. Each batch is characterized by advanced spectroscopic and chromatographic techniques, including NMR, HPLC, and mass spectrometry, to confirm identity, isotopic enrichment (≥98 atom % D), and chemical purity (typically ≥95%). A comprehensive Certificate of Analysis (COA) detailing all specifications is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C. This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95%
Isotopic Purity	≥ 98 atom % D
Chemical Purity	≥ 95%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH limits

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