Description

Atazanavir Sulfate CAS NO 229975-97-7 is the sulfate salt form of a potent and selective azapeptide protease inhibitor. This active pharmaceutical ingredient (API) is critical for the formulation of antiretroviral medications used in combination therapy. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of treatments for HIV-1 infection.

Application

• Pharmaceutical API: Primary use as the active ingredient in the manufacture of antiretroviral drugs for HIV/AIDS treatment.
• Fixed-Dose Combination Products: Used in combination with other antiretroviral agents (e.g., cobicistat) in single-tablet regimens.
• Clinical Research: Serves as a reference standard and raw material in pharmacokinetic, pharmacodynamic, and bioequivalence studies.
• Formulation Development: Utilized in R&D for developing new dosage forms, including pediatric formulations and generics.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for commercial-scale drug production.
• Regulatory Submissions: Provides the necessary quality-controlled material for DMF (Drug Master File) and regulatory dossier preparation.

Basic Information

Product Name	Atazanavir Sulfate
CAS No.	229975-97-7
Molecular Formula	C38H52N6O7 • H2SO4
Molecular Weight	802.94 g/mol (for sulfate salt)
Synonyms	Atazanavir Sulphate; BMS-232632 Sulfate; (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 Sulfate; Reyataz (Brand Name) API; Azapeptide HIV-1 Protease Inhibitor Sulfate
EINECS	Contact for details

Quality Control

Our Atazanavir Sulfate is manufactured under strict quality management systems. It undergoes rigorous analytical testing to ensure compliance with pharmacopeial standards such as USP and ICH Q7 guidelines. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing purity, identity, and impurity profiles to support your regulatory and production needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Microbial Enumeration	Complies with USP <61>

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