Description

Des-n-(Methoxycarbonyl)-L-tert-Leucine Atazanavir-D5 Trihydrochloride is a high-purity, isotopically labeled derivative of the active pharmaceutical ingredient atazanavir, a key protease inhibitor. This compound is specifically designed for use as an internal standard in quantitative bioanalytical methods, ensuring unparalleled accuracy and reliability in pharmacokinetic and metabolism studies. It is an essential material for pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers engaged in drug development and regulatory compliance testing for HIV therapies.

Application

• Internal Standard for LC-MS/MS: Primary application as a deuterated internal standard for the precise quantification of atazanavir and its metabolites in biological matrices (plasma, serum, tissue).
• Pharmacokinetic (PK) Studies: Enables accurate measurement of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical research.
• Bioanalytical Method Development & Validation: Critical for developing robust, sensitive, and selective analytical methods compliant with FDA, EMA, and ICH guidelines.
• Drug Metabolism Studies: Used in metabolite identification and profiling to understand the metabolic pathways and stability of atazanavir.
• Quality Control in API Manufacturing: Serves as a reference standard for the quality control and purity assessment of atazanavir bulk active pharmaceutical ingredient (API).
• Clinical Trial Support: Provides essential data integrity for bioequivalence and therapeutic drug monitoring studies during clinical trials.

Basic Information

Product Name	Des-n-(Methoxycarbonyl)-L-tert-Leucine Atazanavir-D5 Trihydrochloride
CAS No.	1246817-28-6
Molecular Formula	C38H47D5Cl3N7O7
Molecular Weight	Contact for details
Synonyms	Atazanavir-d5 Trihydrochloride; Atazanavir (D5) Trihydrochloride; BMS-232632-d5 Trihydrochloride; (3S,8S,9S,12S)-9-Benzyl-3,12-di-tert-butyl-8-hydroxy-4,11-dioxo-6-[2-(pyridin-2-yl)phenyl]-2,5,6,10,13-pentaazatetradecanedioic Acid-d5 Trihydrochloride; Deuterated Atazanavir Internal Standard; Atazanavir-d5 IS; Des-n-(Methoxycarbonyl)-L-tert-Leucine Atazanavir (D5) Trihydrochloride
EINECS	Contact for details

Quality Control

Every batch of Des-n-(Methoxycarbonyl)-L-tert-Leucine Atazanavir-D5 Trihydrochloride is manufactured under strict quality management systems and undergoes comprehensive analytical characterization. We guarantee high chemical and isotopic purity as verified by advanced techniques including NMR, HPLC, and mass spectrometry. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting purity, isotopic enrichment, and confirming the absence of interfering impurities. Our quality commitment aligns with the standards expected for critical reference materials in regulated bioanalysis.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

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 (D5)	≥ 98.0 atom % D
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%

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