Description

Fosamprenavir Impurity 1 is a specified impurity and degradation product of the antiretroviral drug Fosamprenavir. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control processes. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Fosamprenavir active pharmaceutical ingredients (APIs) and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Fosamprenavir API and drug products.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release Testing: Employed in routine QC labs to ensure drug substance and product batches meet stringent pharmacopeial (e.g., USP, EP) specifications for impurity limits.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) to establish product shelf life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the drug's impurity profile.
• Process Chemistry Research: Aids in optimizing synthesis and purification processes to minimize the formation of this impurity during API manufacturing.

Basic Information

Product Name	Fosamprenavir Impurity 1
CAS No.	160333-50-6
Molecular Formula	C25H36N3O9PS
Molecular Weight	585.61 g/mol
Synonyms	Fosamprenavir Related Compound 1; Fosamprenavir EP Impurity A; (3S)-Tetrahydro-3-furyl (1S,2R)-3-[[(4-aminophenyl)sulfonyl](isobutyl)amino]-1-benzyl-2-hydroxypropylcarbamate; Amprenavir Impurity; GW 433908 Impurity 1; Lexiva Impurity; Telzir Impurity; Prozei Impurity
EINECS	Contact for details

Quality Control

Every batch of Fosamprenavir Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing desiccated at -20°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Assay (HPLC)	97.0% - 102.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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