Description

Nisoldipine-D6 is a deuterium-labeled analog of the calcium channel blocker nisoldipine, specifically designed for use as an internal standard in quantitative analytical methods. This high-purity, isotopically enriched compound is essential for ensuring accuracy and reliability in mass spectrometry-based analyses, particularly in pharmacokinetic and metabolic studies. It is a critical tool for pharmaceutical research and development, clinical laboratories, and regulatory agencies requiring precise measurement of nisoldipine levels.

Application

• Internal Standard for LC-MS/MS: Primary application as a stable, non-interfering internal standard for the precise quantification of nisoldipine in complex biological matrices like plasma, serum, and tissue homogenates.
• Drug Metabolism and Pharmacokinetics (DMPK): Used in studies to track the absorption, distribution, metabolism, and excretion (ADME) profile of the parent drug, improving data accuracy.
• Bioanalytical Method Development and Validation: Critical for developing, optimizing, and validating robust analytical methods in compliance with FDA, EMA, and ICH guidelines.
• Clinical Trial Support: Enables reliable therapeutic drug monitoring and pharmacokinetic analysis during clinical phases of drug development.
• Forensic and Toxicology Analysis: Supports accurate quantification in forensic investigations or toxicological screenings where nisoldipine is relevant.
• Pharmaceutical Quality Control: Can be utilized in impurity profiling and stability-indicating assay methods for drug substance and product analysis.

Basic Information

Product Name	Nisoldipine-D6
CAS No.	1285910-03-3
Molecular Formula	C20H18D6N2O6
Molecular Weight	~390.43 g/mol
Synonyms	Nisoldipine-d6; Deuterated Nisoldipine; 3,5-Pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, 3-methyl 5-(1-methylethyl) ester, d6; Bay k 5552-d6; Isradipine related compound D (d6); (E)-4-(2-Nitrophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylic acid 3-methyl 5-isopropyl ester-d6
EINECS	Contact for details

Quality Control

Our Nisoldipine-D6 is manufactured under strict quality-controlled conditions to ensure the highest isotopic purity and chemical integrity. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing key parameters such as isotopic purity (≥98% D), chemical purity (by HPLC), and confirmation of structure. We adhere to relevant industry standards to support your regulatory and research requirements.

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 product is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	Yellow to light brown crystalline powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity (D)	≥98 atom % D
Chemical Purity	≥95.0%
Water Content (KF)	≤0.5%
Residue on Ignition	≤0.1%

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