Description

Dapivirine-D11 is a deuterated isotopologue of the non-nucleoside reverse transcriptase inhibitor (NNRTI) Dapivirine, specifically labeled with eleven deuterium atoms. This compound is of critical importance as a stable isotope-labeled internal standard for the precise quantification and pharmacokinetic analysis of Dapivirine in complex biological matrices using advanced analytical techniques like LC-MS/MS. It is an essential tool for pharmaceutical research and development laboratories, clinical testing facilities, and regulatory bodies focused on HIV prevention and treatment strategies, ensuring data accuracy and reliability in method validation and bioanalytical studies.

Application

• Bioanalytical Internal Standard: Primary use as a stable isotope-labeled internal standard for the accurate quantification of Dapivirine in plasma, serum, and tissue samples via LC-MS/MS.
• Pharmacokinetic & Metabolism Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research for HIV microbicide development.
• Method Development & Validation: Critical for developing, validating, and ensuring the robustness and regulatory compliance of analytical methods in Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) environments.
• Drug Impurity Profiling: Used in stability studies and impurity characterization to understand degradation pathways of the parent drug.
• Reference Material for Quality Control: Serves as a high-purity certified reference material (CRM) for calibrating instruments and verifying assay accuracy in quality control laboratories.

Basic Information

Product Name	Dapivirine-D11
CAS No.	1329613-10-6
Molecular Formula	C20H8D11N5
Molecular Weight	~337.4 g/mol
Synonyms	Dapivirine-d11; 4-[[4-[(2,4,6-Trimethylphenyl)amino]-2-pyrimidinyl]amino]benzonitrile-d11; TMC120-d11; Dapivirine (deuterated, 11 atoms); UK-453061-d11; Deuterated Dapivirine Internal Standard; Dapivirine (D11); Dapivirine-d11 (Isotope Labeled)
EINECS	Contact for details

Quality Control

Our Dapivirine-D11 is manufactured under controlled conditions to ensure the highest isotopic and chemical purity required for sensitive analytical applications. Each batch undergoes rigorous quality testing including HPLC for chemical purity, NMR and MS for isotopic enrichment verification, and residual solvent analysis. Certificates of Analysis (COA) are provided, detailing batch-specific results for identity, assay, isotopic purity, and impurities. Production adheres to relevant quality guidelines suitable for research and development use.

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 if specified and opened in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity (D11)	≥98.0 atom % D
Chemical Purity (by NMR)	≥97.0%
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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