Description

[2H4]-Atazanavir is a stable isotope-labeled analog of the antiretroviral drug Atazanavir, specifically deuterated at four positions. This compound is an essential internal standard for the precise quantification of Atazanavir in complex biological matrices using advanced analytical techniques like LC-MS/MS. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and academic institutions engaged in pharmacokinetic studies, drug metabolism research, and bioanalytical method development.

Application

• Bioanalytical Internal Standard: Serves as a critical reference standard for the accurate and reliable quantification of Atazanavir in plasma, serum, and other biological fluids via mass spectrometry.
• Pharmacokinetic (PK) and Pharmacodynamic (PD) Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) in clinical and pre-clinical research.
• Drug Metabolism Research: Used in metabolite identification and profiling studies to understand the biotransformation pathways of Atazanavir.
• Method Development and Validation: Essential for developing, optimizing, and validating robust LC-MS/MS methods in compliance with regulatory guidelines (e.g., FDA, EMA).
• Quality Control in Pharmaceutical Manufacturing: Can be utilized in impurity profiling and ensuring the consistency of active pharmaceutical ingredient (API) batches.
• Clinical Trial Support: Provides the analytical foundation for measuring drug concentrations in patient samples during clinical trials for HIV treatment.

Basic Information

Product Name	[2H4]-Atazanavir
CAS No.	1132747-16-0
Molecular Formula	C38H48D4N6O7
Molecular Weight	Approx. 708.9 g/mol
Synonyms	Deuterated Atazanavir; Atazanavir-d4; (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13-pentazatetradecanedioic Acid-d4; BMS-232632-d4; Atazanavir (tetradeutero); Atazanavir Internal Standard-d4
EINECS	Contact for details

Quality Control

Every batch of [2H4]-Atazanavir is manufactured under strict quality management systems and undergoes comprehensive analytical testing. We guarantee high chemical purity, isotopic enrichment, and stability to ensure performance as a reliable internal standard. A comprehensive Certificate of Analysis (COA) detailing purity (by HPLC), isotopic purity (by MS), and identity confirmation (by NMR and IR) is provided with each shipment to support your regulatory and research requirements.

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 should be handled under anhydrous conditions to maintain stability and purity. Allow the vial to equilibrate to room temperature before opening to minimize moisture condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (MS)	≥ 98.0 atom % D
Chemical Purity (HPLC)	≥ 95.0%
Residual Solvents (GC)	Meets ICH guidelines
Water Content (KF)	≤ 1.0%

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