Description

Atazanavir Impurity 5 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification, quantification, and monitoring of process-related impurities during the manufacture of the antiretroviral drug Atazanavir. It is an essential material for analytical laboratories, research institutions, and pharmaceutical companies focused on method development, validation, and regulatory compliance. The product is supplied with comprehensive analytical data to support its use in GMP and R&D environments.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the analysis of Atazanavir sulfate drug substance and finished products.
• Method Development & Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Used in routine QC testing to monitor and control the level of this specific impurity, ensuring batch-to-batch consistency and product safety.
• Stability Studies: Employed as an analytical marker in forced degradation and long-term stability studies of Atazanavir formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Supports process chemistry research aimed at understanding and minimizing the formation of this impurity during synthesis.

Basic Information

Product Name	Atazanavir Impurity 5
CAS No.	857900-54-0
Molecular Formula	C38H52N6O7
Molecular Weight	704.87 g/mol
Synonyms	Atazanavir Related Compound 5; Atazanavir Sulfate Impurity 5; (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 5; Reyataz Impurity 5
EINECS	Contact for details

Quality Control

Every batch of Atazanavir Impurity 5 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and spectral data.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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