Description

Fosamprenavir Impurity 2 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Fosamprenavir. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of antiviral medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Fosamprenavir API and its formulations.
• Analytical Method Development & Validation: Used as a critical component in developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine quality control testing to ensure API batches meet stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) during drug stability testing.
• Regulatory Compliance & Filings: Provides necessary data for regulatory submissions (e.g., to FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Used in R&D to understand the degradation pathways and chemical behavior of Fosamprenavir during synthesis and formulation processes.

Basic Information

Item	Detail
Product Name	Fosamprenavir Impurity 2
CAS No.	853904-81-1
Molecular Formula	C25H36N3O9PS
Molecular Weight	585.61 g/mol
Synonyms	Fosamprenavir Related Compound 2; (3S)-Tetrahydro-3-furyl (1S,2R)-3-[[(4-aminophenyl)sulfonyl](isobutyl)amino]-1-benzyl-2-(phosphonooxy)propylcarbamate; Amprenavir Impurity; GW 433908 Impurity; Telzir Impurity; Lexiva Impurity; (3S)-Tetrahydrofuran-3-yl [(1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropyl)amino]-1-benzyl-2-(phosphonooxy)propyl]carbamate
EINECS	Contact for details

Quality Control

Every batch of Fosamprenavir Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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 conditions to maintain stability and purity. 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 single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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