Description

Fosamprenavir-D4 CAS NO 1133702-41-6 is a deuterated isotopologue of the antiretroviral prodrug Fosamprenavir, specifically labeled with four deuterium atoms. This stable-labeled compound is a critical reference standard and internal standard in quantitative bioanalytical research, ensuring the highest accuracy and reliability in pharmacokinetic and metabolic studies. It is an essential tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory bodies involved in the development and quality control of HIV protease inhibitors.

Application

• Bioanalytical Reference Standard: Serves as a primary standard for the calibration and validation of LC-MS/MS and HPLC methods in drug metabolism and pharmacokinetics (DMPK) studies.
• Quantitative Internal Standard: Used as an internal standard to enhance the precision and accuracy of mass spectrometry-based assays for Fosamprenavir and its metabolites in biological matrices like plasma and serum.
• Metabolic Pathway Tracing: Facilitates the investigation of metabolic pathways and the identification of metabolites due to its isotopic signature, aiding in drug safety and efficacy profiling.
• Pharmaceutical Quality Control: Employed in the quality assurance and stability testing of Fosamprenavir-based drug products to ensure batch-to-batch consistency and regulatory compliance.
• Clinical Research Support: Critical for conducting robust clinical trials, enabling reliable measurement of drug concentration levels in patients.
• Impurity Profiling: Assists in the identification and quantification of process-related impurities and degradants during API manufacturing.

Basic Information

Item	Details
Product Name	Fosamprenavir-D4
CAS No.	1133702-41-6
Molecular Formula	C25H31D4N3O9PS
Molecular Weight	Approx. 587.6 g/mol
Synonyms	Fosamprenavir-d4; GW 433908G-d4; (3S)-Tetrahydro-3-furyl (1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1-(phenylmethyl)propylcarbamate-d4; Lexiva-d4 (labeled); Telzir-d4 (labeled); Amprenavir Phosphate Ester-d4; Deuterated Fosamprenavir; [2H4]-Fosamprenavir
EINECS	Contact for details

Quality Control

Our Fosamprenavir-D4 is manufactured under strict quality systems to ensure it meets the exacting requirements for a certified reference material. Each batch undergoes comprehensive analytical characterization, including NMR, HPLC, and mass spectrometry, to confirm chemical identity, isotopic purity (D-enrichment), and chemical purity. A detailed Certificate of Analysis (COA) is provided, which includes batch-specific data on purity, water content, and residual solvents. Our quality commitment aligns with the standards expected for pharmaceutical research and regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This product is hygroscopic (moisture-sensitive). Keep the container tightly sealed in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC/MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity (D-enrichment)	≥98 atom % D
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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