Description

Barnidipine-D4 Hydrochloride is a deuterated isotopologue of the calcium channel blocker Barnidipine, specifically labeled with four deuterium atoms. This stable-labeled internal standard is critical for ensuring the accuracy and reliability of quantitative mass spectrometric analyses in pharmaceutical research and development. It is an essential tool for scientists and quality control laboratories engaged in pharmacokinetic studies, metabolic profiling, and bioanalytical method validation for Barnidipine. The product is supplied as the hydrochloride salt to enhance stability and solubility for analytical applications.

Application

• Internal Standard for LC-MS/MS: Primary use as a quantitative reference standard in Liquid Chromatography-Tandem Mass Spectrometry for the precise measurement of Barnidipine in biological matrices.
• Pharmacokinetic and Bioavailability Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Metabolite Identification and Profiling: Aids in the identification and quantification of Barnidipine metabolites using high-resolution mass spectrometry.
• Bioanalytical Method Development and Validation: Serves as a critical component in developing, optimizing, and validating robust analytical methods compliant with FDA, EMA, and ICH guidelines.
• Drug Impurity and Degradation Product Analysis: Used as a reference in stability-indicating methods to assess drug purity and identify degradation pathways.
• Quality Control in Pharmaceutical Manufacturing: Supports in-process testing and final product release testing to ensure batch-to-batch consistency and potency.

Basic Information

Product Name	Barnidipine-D4 Hydrochloride
CAS No.	117131-01-8
Molecular Formula	C27H31D4N3O6 • HCl
Molecular Weight	Approx. 546.1 g/mol (Contact for details)
Synonyms	Barnidipine-d4 HCl; (R*,S*)-Mepirodipine-d4 Hydrochloride; (±)-Barnidipine-d4 Hydrochloride; YM-730-d4; 3-(1-Benzyl-3-piperidinyl) 5-methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydro-3,5-pyridinedicarboxylate-d4 hydrochloride; 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid 3-[1-(phenylmethyl)-3-piperidinyl] 5-methyl ester-d4 hydrochloride
EINECS	Contact for details

Quality Control

Our Barnidipine-D4 Hydrochloride is manufactured under strict quality systems to ensure the high chemical purity and isotopic enrichment required for sensitive analytical applications. Each batch undergoes comprehensive testing, including HPLC for chemical purity, NMR and MS for structural confirmation and isotopic enrichment, and residual solvent analysis. Certificates of Analysis (COA) detailing all test results, including purity, isotopic purity (D-enrichment), and assay, are provided and traceable to in-house reference standards. Our quality commitment supports compliance with cGMP and relevant ICH guidelines for reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C, in a dry environment. The product is hygroscopic (moisture-sensitive); containers must be kept tightly sealed and protected from humidity to maintain stability and purity. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity (D-enrichment)	≥98 atom % D (Contact for details)
Assay (on dried basis)	95.0% - 105.0%
Water Content (KF)	≤1.0%
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.