Description

Atazanavir Ep Impurity G is a specified impurity of the antiretroviral drug Atazanavir Sulfate, used in pharmaceutical reference standards and analytical research. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, quality control (QC) laboratories, and research institutions engaged in method development, stability studies, and regulatory compliance testing for HIV treatment medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Atazanavir Ep Impurity G in Atazanavir Sulfate API and finished drug products.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurities in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control and Batch Release: Employed in routine QC testing to ensure API and drug product batches meet stringent pharmacopeial (e.g., USP, EP) specifications for impurity profiles.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Research and Development: Facilitates process chemistry research to understand and minimize the formation of this impurity during API synthesis.

Basic Information

Product Name	Atazanavir Ep Impurity G
CAS No.	1332981-16-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Atazanavir Impurity G; Atazanavir Related Compound G; (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; Atazanavir EP Impurity G; Atazanavir Sulfate Impurity G; UNII-7Q0FQ8T01I
EINECS	Contact for details

Quality Control

Our Atazanavir Ep Impurity G is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, related substance analysis, and structural confirmation (NMR, MS) to ensure identity, potency, and traceability. Certificates of Analysis (COA) detailing all test results are provided and support compliance with relevant pharmacopeial standards. Our quality commitment ensures material suitability for its intended use in regulatory and analytical applications.

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); the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.5%

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