Description

(-)-Alfa-Benidipine-D5 Hydrochloride is a deuterated isotopologue of the potent calcium channel blocker benidipine, specifically labeled for use as an internal standard in analytical chemistry. This high-purity reference material is essential for ensuring the accuracy and reliability of quantitative bioanalytical methods, such as LC-MS/MS, in pharmacokinetic and metabolism studies. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory agencies involved in the development and quality control of cardiovascular drugs.

Application

• Internal Standard for LC-MS/MS Analysis: Serves as a critical deuterated internal standard for the precise quantification of benidipine and its metabolites in complex biological matrices like plasma, serum, and tissue homogenates.
• Pharmacokinetic & Metabolism Studies: Enables accurate tracing of drug absorption, distribution, metabolism, and excretion (ADME) profiles during preclinical and clinical development stages.
• Bioanalytical Method Development & Validation: Used to develop, optimize, and validate robust analytical methods in compliance with FDA, EMA, and ICH guidelines.
• Drug Impurity Profiling & Stability Testing: Assists in identifying and quantifying potential degradants or related substances in drug substances and products.
• Isotope Dilution Mass Spectrometry (IDMS): Employed in high-accuracy IDMS techniques for definitive method validation and clinical assay standardization.

Basic Information

Item	Detail
Product Name	(-)-Alfa-Benidipine-D5 Hydrochloride
CAS No.	129262-07-3
Molecular Formula	C28H31D5ClN2O6 • HCl
Molecular Weight	~ 583.1 g/mol (for monoisotopic mass)
Synonyms	Benidipine-d5 Hydrochloride; (R)-Benidipine-d5 HCl; (-)-Benidipine-d5 Hydrochloride; (2R)-1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid 2-[(3R)-1-(phenylmethyl)-3-piperidinyl] ethyl methyl ester-d5 hydrochloride; Coniel-d5 (labeled analog); KW-3049-d5; Isotopically Labeled Benidipine Internal Standard
EINECS	Contact for details

Quality Control

Every batch of (-)-Alfa-Benidipine-D5 Hydrochloride is manufactured and tested under strict quality management systems. We guarantee high chemical and isotopic purity, supported by comprehensive analytical data including NMR, HPLC, and mass spectrometry. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting purity, isotopic enrichment, and confirming the absence of unlabeled compound. Our quality commitment aligns with the standards expected for pharmaceutical reference materials.

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 compound is hygroscopic (moisture-sensitive); the container must be kept in a dry environment and sealed after each use to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum confirms molecular ion and fragmentation pattern
Purity (HPLC)	≥ 98.0% (chemical purity)
Isotopic Purity (by MS)	≥ 98 atom % D (D5 enrichment)
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.