Description

Lercanidipine 13C D3 Hydrochloride is a stable isotope-labeled internal standard of the calcium channel blocker Lercanidipine, specifically designed for quantitative bioanalytical applications. This high-purity reference material is critical for ensuring the accuracy and reliability of pharmacokinetic and metabolism studies, providing unmatched specificity in mass spectrometry-based assays. It is an essential tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory bodies engaged in drug development and bioequivalence testing for cardiovascular therapeutics.

Application

• Quantitative Bioanalysis: Serves as a critical internal standard for the precise quantification of Lercanidipine and its metabolites in biological matrices (plasma, serum, urine) using LC-MS/MS and GC-MS.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate measurement of drug absorption, distribution, metabolism, and excretion (ADME) profiles in clinical and pre-clinical research.
• Drug Metabolism Studies: Facilitates the identification and quantification of metabolite formation, aiding in the understanding of metabolic pathways and potential drug-drug interactions.
• Regulatory Compliance & Bioequivalence Testing: Supports method development and validation for studies required by regulatory agencies (FDA, EMA) for generic drug approval.
• Forensic & Clinical Toxicology: Used in specialized assays for therapeutic drug monitoring (TDM) or in forensic investigations involving calcium channel blockers.

Basic Information

Product Name	Lercanidipine 13C D3 Hydrochloride
CAS No.	1261397-71-0
Molecular Formula	C36H3813C1D3ClN2O6 • HCl
Molecular Weight	~ 694.68 g/mol
Synonyms	Lercanidipine-13C,d3 Hydrochloride; (R,S)-1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid 2-[(3,3-diphenylpropyl)methylamino]-1,1-dimethylethyl methyl ester-13C,d3 hydrochloride; Lercanidipine (phenyl-13C,d3) Hydrochloride; Lercanidipine (13C D3) HCl; Lercanidipine-d3-13C Hydrochloride; Lercanidipine Internal Standard-13C D3; Zanidip-13C,d3 Hydrochloride
EINECS	Contact for details

Quality Control

Our Lercanidipine 13C D3 Hydrochloride is manufactured under strict quality systems to ensure the highest isotopic and chemical purity for demanding analytical applications. Each batch is fully characterized by advanced spectroscopic and chromatographic techniques, including NMR, HPLC, and mass spectrometry, to confirm identity, isotopic enrichment, and purity. A comprehensive Certificate of Analysis (COA) is provided, detailing assay, isotopic purity, chemical purity, and residual solvent content, supporting compliance with GLP and ISO 17025 standards.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dedicated freezer. The product is hygroscopic (moisture-sensitive). Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC-MS)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity	≥ 99 atom % 13C; ≥ 98 atom % D
Chemical Purity	≥ 95.0%
Residual Solvents (GC)	Meets ICH guidelines
Water Content (KF)	≤ 1.0%

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