Description

2-Amino Nevirapine-D3 is a deuterium-labeled analog of a key nevirapine intermediate, specifically designed for use as an internal standard in analytical chemistry. This compound is critical for ensuring the accuracy and reliability of quantitative analyses, particularly in pharmacokinetic and metabolic studies. It is an essential material for pharmaceutical R&D laboratories, contract research organizations (CROs), and manufacturers engaged in the development and quality control of antiviral drugs.

Application

• Internal Standard for LC-MS/MS: Primary application as a stable, isotopically labeled internal standard for the precise quantification of nevirapine and its metabolites in complex biological matrices like plasma and serum.
• Pharmaceutical R&D: Used in method development and validation during the research and development stages of non-nucleoside reverse transcriptase inhibitors (NNRTIs) and related antiviral compounds.
• Bioanalytical Studies: Enables accurate pharmacokinetic (PK) and pharmacodynamic (PD) profiling, bioavailability, and bioequivalence studies in clinical and pre-clinical trials.
• Metabolite Tracing: Facilitates the study of drug metabolism and the identification of metabolic pathways due to its deuterium labeling, which provides a distinct mass spectrometric signature.
• Quality Control & Assurance: Supports high-purity analysis and impurity profiling in the manufacturing process of active pharmaceutical ingredients (APIs).
• Reference Standard: Serves as a certified reference material (CRM) for calibrating analytical instruments and ensuring regulatory compliance in GLP/GMP environments.

Basic Information

Product Name	2-Amino Nevirapine-D3
CAS No.	1346605-12-6
Molecular Formula	C15H13D3N4O
Molecular Weight	269.32 g/mol
Synonyms	2-Amino-4-methyl-3-(methyl-d3)-5-(2-pyridinyl)-7H-pyrrolo[2,3-d]pyrimidin-6(5H)-one; Nevirapine-2-amino-D3; Deuterated 2-Amino Nevirapine; 2-Amino-5-(2-pyridinyl)-4-methyl-3-(trideuteriomethyl)-6,7-dihydro-5H-pyrrolo[2,3-d]pyrimidin-6-one; 2-Amino Nevirapine (methyl-d3); 2-Amino-4-methyl-3-(CD3)-5-(2-pyridinyl)-7H-pyrrolo[2,3-d]pyrimidin-6(5H)-one; 2-Amino-NVP-d3; 2-Amino Nevirapine Internal Standard
EINECS	Contact for details

Quality Control

Every batch of 2-Amino Nevirapine-D3 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and isotopic enrichment meet the highest standards. Our quality protocols are designed to support regulatory filings, with testing typically including HPLC, NMR, and mass spectrometry. Certificates of Analysis (COA) detailing batch-specific results for purity, chemical and isotopic composition are provided and available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); ensure the container is sealed under an inert atmosphere after each use to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D3)	≥ 98 atom % D
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.