Description

Atazanavir Impurity 7 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Atazanavir sulfate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The reliable identification and quantification of this impurity are essential for maintaining the highest standards in drug development and production.

Application

• Primary use as a certified reference standard for the quantitative and qualitative analysis of Atazanavir sulfate.
• Critical component in pharmaceutical research and development (R&D) for impurity identification and characterization.
• Essential for quality control (QC) and quality assurance (QA) processes in API manufacturing.
• Used in stability studies and forced degradation studies to monitor impurity profiles.
• Vital for regulatory submissions (e.g., to FDA, EMA) requiring detailed impurity information.
• Supports method development and validation for HPLC, UPLC, and other chromatographic techniques.
• Applied in academic and institutional research focused on antiretroviral drug chemistry.

Basic Information

Product Name	Atazanavir Impurity 7
CAS No.	1192224-26-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Atazanavir Related Compound 7; Atazanavir Sulfate Impurity 7; Atazanavir EP Impurity G; Atazanavir USP Impurity; (2S,3S)-3-[(S)-2-(2,4-Difluorophenyl)-2-hydroxy-1-(1H-1,2,4-triazol-1-yl)ethyl]-4-(4-methoxyphenyl)-1-(4-(2-pyridyl)benzyl)-2-azetidinone; UNII-Contact for details; BMS-232632 Impurity 7
EINECS	Contact for details

Quality Control

Every batch of Atazanavir Impurity 7 is manufactured and controlled under a strict quality management system. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results against predefined specifications. We support compliance with ICH Q3A/B guidelines and other relevant pharmacopeial standards (USP, EP).

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 material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to ensure long-term stability. The original container should be kept sealed in a desiccator when not in use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	< 20 ppm

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