Description

Atazanavir D6 is a deuterated internal standard of the antiretroviral drug Atazanavir, specifically designed for use in quantitative mass spectrometry. This high-purity, isotopically labeled compound is essential for ensuring the accuracy and reliability of pharmacokinetic and bioanalytical studies. It is a critical tool for pharmaceutical researchers, clinical laboratories, and contract research organizations (CROs) engaged in drug development and therapeutic monitoring.

Application

• Quantitative Bioanalysis: Serves as a stable isotope-labeled internal standard in LC-MS/MS methods for the precise quantification of Atazanavir in biological matrices such as plasma, serum, and tissue homogenates.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate measurement of drug concentration-time profiles to determine absorption, distribution, metabolism, and excretion (ADME) parameters.
• Therapeutic Drug Monitoring (TDM): Used in clinical assays to monitor Atazanavir levels in patient samples, aiding in dose optimization and ensuring therapeutic efficacy while minimizing toxicity.
• Drug Metabolism Research: Facilitates the study of metabolic pathways and the identification of metabolites by providing a non-interfering isotopic reference.
• Method Development and Validation: A key component in developing and validating robust, regulatory-compliant analytical methods for Good Laboratory Practice (GLP) and clinical trials.
• Quality Control in Manufacturing: Can be utilized in impurity profiling and stability-indicating methods for the quality assurance of Atazanavir active pharmaceutical ingredient (API) and finished dosage forms.

Basic Information

Product Name	Atazanavir D6
CAS No.	1092540-50-5
Molecular Formula	C38H46D6N6O7
Molecular Weight	712.90 g/mol
Synonyms	Atazanavir-d6; BMS-232632-d6; (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-pentaazatetradecanedioic Acid Dimethyl Ester-d6; Deuterated Atazanavir; Atazanavir Internal Standard
EINECS	Contact for details

Quality Control

Every batch of Atazanavir D6 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of isotopic purity and chemical identity. Our quality protocols are designed to meet the stringent requirements of research and bioanalytical applications. A comprehensive Certificate of Analysis (COA) detailing purity (by HPLC), isotopic enrichment, and spectroscopic confirmation is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry environment. This product is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability. 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 (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity	≥ 98.0 atom % D
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.5%

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