Description

Atazanavir Impurity 8 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Atazanavir sulfate, an antiretroviral medication. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine quality control testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Atazanavir sulfate API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing in pharmaceutical manufacturing to ensure compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed to track the formation of degradation products in Atazanavir formulations under various stress conditions.
• Research & Development: Used in R&D laboratories for studying the degradation pathways and chemical behavior of Atazanavir.

Basic Information

Product Name	Atazanavir Impurity 8
CAS No.	1028634-76-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Atazanavir Related Compound 8; Atazanavir Sulfate Impurity 8; Atazanavir EP Impurity I; Atazanavir USP Impurity; (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 (Potential IUPAC); BMS-232632 Impurity 8; ATV Impurity 8
EINECS	Contact for details

Quality Control

Our Atazanavir Impurity 8 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced chromatographic and spectroscopic methods. We adhere to relevant pharmacopeial standards (USP/EP) and ICH guidelines to support your regulatory and compliance needs.

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 Certificate of Analysis. The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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