Description

Rac Benidipine-D5 Hydrochloride is a deuterated isotopologue of the calcium channel blocker benidipine, specifically designed for use as an internal standard in quantitative analytical methods. This high-purity reference material is critical for ensuring accuracy and reliability in pharmacokinetic and metabolic studies, where precise measurement is paramount. It is an essential tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers engaged in drug development and bioanalytical method validation.

Application

• Internal Standard for LC-MS/MS: Primary application as a stable, isotopically labeled internal standard for the accurate quantification of benidipine and its metabolites in complex biological matrices like plasma, serum, and urine.
• Drug Metabolism and Pharmacokinetics (DMPK): Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical studies.
• Bioanalytical Method Development & Validation: Serves as a critical component in developing robust, sensitive, and reproducible HPLC-MS or GC-MS assays compliant with FDA and ICH guidelines.
• Pharmaceutical Quality Control: Used in impurity profiling and stability-indicating assays to monitor the active pharmaceutical ingredient (API) during formulation and storage.
• Clinical Research: Supports therapeutic drug monitoring and bioavailability/bioequivalence studies for cardiovascular drug formulations.
• Isotope Dilution Mass Spectrometry (IDMS): Employed in high-accuracy analytical techniques that require an isotopically labeled analog to correct for sample preparation and instrumental variances.

Basic Information

Product Name	Rac Benidipine-D5 Hydrochloride
CAS No.	1329633-88-6
Molecular Formula	C28H26D5ClN2O6 • HCl
Molecular Weight	~ 582.0 g/mol
Synonyms	Benidipine-d5 Hydrochloride; (±)-Benidipine-d5 Hydrochloride; rac-Benidipine-d5 HCl; 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid 2-[(3R*,1'R*)-1-(phenyl-d5)butyl] 1-methylethyl ester hydrochloride; Coniel-d5 (labeled analog); KW-3049-d5 Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Rac Benidipine-D5 Hydrochloride is manufactured and analyzed under strict quality management systems. We guarantee high chemical and isotopic purity, with comprehensive testing performed using advanced techniques like NMR, HPLC, and mass spectrometry. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming identity, purity (typically ≥98% by HPLC), isotopic enrichment (≥98 atom % D), and other critical specifications to ensure suitability for its intended use as an analytical reference standard.

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 compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity. Keep the container sealed under an inert atmosphere when not in use for extended periods.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (Mass Spec)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (Atom % D)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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