Description

Atazanavir Impurity 6 is a designated impurity standard used in the analytical profiling and quality control of the antiretroviral drug Atazanavir. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) by accurately identifying and quantifying process-related impurities. It is an essential tool for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs departments involved in the development and manufacturing of HIV/AIDS therapeutics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Atazanavir Impurity 6 in Atazanavir API and finished dosage forms.
• Method Development and Validation: Critical for developing, optimizing, and validating stability-indicating analytical methods, such as HPLC and UPLC.
• Quality Control & Batch Release: Used in routine QA/QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines and pharmacopeial specifications (USP, EP).
• Stability Studies: Employed to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of Atazanavir.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to agencies like the FDA and EMA.
• Process Chemistry Research: Aids in understanding the synthetic pathway of Atazanavir and optimizing manufacturing processes to minimize impurity formation.

Basic Information

Product Name	Atazanavir Impurity 6
CAS No.	1006868-81-0
Molecular Formula	C38H52N6O7
Molecular Weight	704.87 g/mol
Synonyms	Atazanavir Related Compound 6; Atazanavir EP Impurity 6; Atazanavir USP Impurity 6; (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; BMS-232632 Impurity 6
EINECS	Contact for details

Quality Control

Every batch of Atazanavir Impurity 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and related substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Assay (HPLC)	98.0% - 102.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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