Description

Nevirapine-D3 is a deuterated isotopologue of the non-nucleoside reverse transcriptase inhibitor (NNRTI) nevirapine, specifically labeled with three deuterium atoms. This stable isotope-labeled compound is an essential reference standard and internal standard for the precise quantification and pharmacokinetic studies of nevirapine in biological matrices using advanced analytical techniques like LC-MS/MS. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in drug metabolism and bioanalytical method development.

Application

• Bioanalytical Reference Standard: Serves as a critical internal standard for the accurate quantification of nevirapine in plasma, serum, and other biological samples via mass spectrometry.
• Pharmacokinetic & Metabolism Studies: Used in ADME (Absorption, Distribution, Metabolism, Excretion) research to track the parent drug's fate without isotopic interference.
• Method Development & Validation: Essential for developing and validating robust, sensitive, and specific LC-MS/MS methods in compliance with FDA and ICH guidelines.
• Drug Impurity Profiling: Aids in the identification and characterization of process-related impurities and degradation products in active pharmaceutical ingredient (API) batches.
• Clinical Trial Support: Provides reliable data for therapeutic drug monitoring and bioequivalence studies during clinical trials.
• Forensic & Doping Control Analysis: Enables precise detection and confirmation of nevirapine in forensic toxicology and anti-doping laboratories.

Basic Information

Product Name	Nevirapine-D3
CAS No.	1051419-24-9
Molecular Formula	C15H11D3N4O
Molecular Weight	269.31 g/mol
Synonyms	11-Cyclopropyl-5,11-dihydro-4-methyl-6H-dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one-d3; 11-Cyclopropyl-4-methyl-5,11-dihydro-6H-dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one-d3; Deuterated Nevirapine; Nevirapine (methyl-d3); Nevirapine-d3 (methyl-d3); [2H3]-Nevirapine
EINECS	Contact for details

Quality Control

Our Nevirapine-D3 is manufactured under strict quality control protocols to ensure high chemical and isotopic purity, meeting the exacting standards for analytical reference materials. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results for identity, purity (by HPLC), isotopic enrichment, and residual solvents. We support compliance with ICH Q2(R1) and USP guidelines for analytical procedures.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This product is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to minimize exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (deuterium)	≥ 99.0 atom % D
Chemical Purity	≥ 98.0%
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.