Description

Atazanavir S,S,R,S-Diastereomer CAS NO 1292296-10-6 is a specific stereoisomeric form of the active pharmaceutical ingredient Atazanavir, a potent protease inhibitor. This high-purity diastereomer is a critical reference standard and impurity standard used in pharmaceutical research, development, and quality control. It is essential for scientists and manufacturers in the pharmaceutical and fine chemical industries who require precise analytical materials to ensure drug purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of stereoisomeric impurities in Atazanavir sulfate bulk drug and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating chromatographic methods (e.g., HPLC, UPLC) for stereochemical purity assessment.
• Process Chemistry & Impurity Profiling: Employed in route scouting, process optimization, and monitoring to control and minimize the formation of this specific diastereomeric impurity during synthesis.
• Regulatory Compliance & Filing: Provides essential data for regulatory submissions (e.g., to FDA, EMA) to establish impurity limits and demonstrate control of the manufacturing process.
• Academic & Contract Research: Utilized in pharmacological and metabolic studies to understand the behavior and impact of individual stereoisomers.
• Quality Control (QC) Testing: Acts as a system suitability test component and a quantitation standard in routine QC release testing of Atazanavir API and formulations.

Basic Information

Product Name	Atazanavir S,S,R,S-Diastereomer
CAS No.	1292296-10-6
Molecular Formula	C38H52N6O7
Molecular Weight	704.87 g/mol
Synonyms	Atazanavir Diastereomer (S,S,R,S); (3S,8S,9S,12S)-9-Benzyl-3-tert-butyl-11,11-dioxo-8-hydroxy-12-[(2S,3S)-2-hydroxy-3-[(2-isopropyl-1,3-thiazol-4-yl)methyl]carbamoyl]octahydro-6H-pyrido[1',2':1,5]pyrrolo[2,3-b]indole-6-carboxylic acid methyl ester; BMS-232632 Diastereomer; ATV Diastereomer; Atazanavir Stereoisomer; Atazanavir Related Compound
EINECS	Contact for details

Quality Control

Our Atazanavir S,S,R,S-Diastereomer is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (NMR, IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment. We support compliance with ICH Q3A, Q3B, and Q6A guidelines for impurities and specifications.

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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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