Description

Fosamprenavir Impurity 3 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) Fosamprenavir, a protease inhibitor used in HIV therapy. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, stability studies, and impurity profiling to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control and release testing of Fosamprenavir API and its finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for accurate impurity identification and quantification.
• Stability Studies & Degradation Profiling: Employed in forced degradation and long-term stability studies to monitor impurity formation and establish shelf-life specifications.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Research & Development: Utilized in synthetic chemistry research to study degradation pathways and to support the development of robust manufacturing processes.
• Pharmacopeial Testing: Acts as a system suitability component in testing to comply with monographs from USP, EP, or other international pharmacopeias.

Basic Information

Product Name	Fosamprenavir Impurity 3
CAS No.	1005324-40-2
Molecular Formula	C25H34N3O9PS
Molecular Weight	583.59 g/mol
Synonyms	Fosamprenavir Related Compound 3; Fosamprenavir EP Impurity C; (3S)-Tetrahydro-3-furyl (1S,2R)-3-[[(4-aminophenyl)sulfonyl](isobutyl)amino]-1-benzyl-2-hydroxypropylcarbamate sulfamate; Amprenavir impurity; GW 433908 Impurity; Telzir Impurity; Lexiva Impurity
EINECS	Contact for details

Quality Control

Every batch of Fosamprenavir Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality assurance and regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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