Description

Nisoldipine D4 CAS NO 1219795-47-7 is a deuterated isotopologue of the calcium channel blocker Nisoldipine, where four hydrogen atoms are replaced by deuterium. This stable isotope-labeled compound is a critical reference standard and internal standard in quantitative bioanalytical research, ensuring the accuracy and reliability of mass spectrometry-based assays. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory bodies for pharmacokinetic studies, drug metabolism research, and ensuring compliance in bioequivalence testing.

Application

• Internal Standard for LC-MS/MS: Serves as a crucial internal standard for the precise quantification of Nisoldipine in biological matrices (plasma, serum, urine) using liquid chromatography-tandem mass spectrometry.
• Pharmacokinetic & Metabolism Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Bioanalytical Method Development & Validation: Used as a certified reference material to develop, validate, and ensure the robustness of analytical methods in compliance with FDA, EMA, and ICH guidelines.
• Drug Impurity Profiling: Assists in the identification and quantification of deuterated metabolites or related substances in drug substance and product analysis.
• Stable Isotope Dilution Assays: Fundamental component in high-precision isotope dilution mass spectrometry techniques to minimize matrix effects and improve analytical accuracy.

Basic Information

Product Name	Nisoldipine D4
CAS No.	1219795-47-7
Molecular Formula	C28H30D4N2O7
Molecular Weight	490.59 g/mol (approx.)
Synonyms	Nisoldipine-d4; Deuterated Nisoldipine; 3,5-Pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, 3-methyl 5-(2-methylpropyl) ester, d4; Bay k 5552-d4; 1,4-Dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylic acid methyl 2-methylpropyl ester-d4; Isobutyl methyl 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylate-d4
EINECS	Contact for details

Quality Control

Our Nisoldipine D4 is manufactured under strict quality control protocols to ensure the highest standards of isotopic purity and chemical integrity. Each batch is characterized using advanced analytical techniques including NMR (¹H, ²H) and High-Resolution Mass Spectrometry (HRMS) to confirm deuteration level and identity. We provide comprehensive Certificates of Analysis (COA) detailing assay purity (typically ≥98% by HPLC), isotopic enrichment (≥99 atom % D), and impurity profiles, supporting compliance with GLP and GMP standards for research use.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, cool place. This product is hygroscopic (moisture-sensitive) and light-sensitive. For long-term storage, keep desiccated under an inert atmosphere. Allow the sealed vial to equilibrate to room temperature before opening to prevent moisture condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (NMR)	Conforms to structure
Identification (HRMS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (²H NMR/MS)	≥ 99 atom % D
Chemical Purity (by difference)	≥ 99.0%
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C

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