Description

Sofosbuvir D6 CAS NO 1868135-06-1 is a deuterium-labeled analog of the direct-acting antiviral agent Sofosbuvir, serving as a critical internal standard for precise quantitative analysis in pharmaceutical research and development. This high-purity, isotopically labeled compound is essential for ensuring the accuracy and reliability of bioanalytical methods, including LC-MS/MS, during drug metabolism and pharmacokinetic (DMPK) studies. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in the development and quality control of antiviral therapies.

Application

• Internal Standard for Bioanalysis: Used as a stable isotope-labeled internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the accurate quantification of Sofosbuvir and its metabolites in biological matrices (plasma, serum, tissue).
• Drug Metabolism and Pharmacokinetics (DMPK): Critical for conducting mass spectrometry-based assays to study the absorption, distribution, metabolism, and excretion (ADME) profile of Sofosbuvir in preclinical and clinical research.
• Pharmaceutical R&D Quality Control: Employed in method development and validation to ensure the specificity, accuracy, and precision of analytical procedures for active pharmaceutical ingredient (API) and finished product testing.
• Reference Standard for Impurity Profiling: Acts as a certified reference material to identify and quantify process-related impurities or degradants in Sofosbuvir API manufacturing.
• Clinical Trial Support: Facilitates reliable therapeutic drug monitoring and pharmacokinetic analysis during clinical trials for hepatitis C virus (HCV) treatments.

Basic Information

Product Name	Sofosbuvir D6
CAS No.	1868135-06-1
Molecular Formula	C₂₂H₂₃D₆FN₃O₉P
Molecular Weight	531.46 g/mol (deuterated form)
Synonyms	PSI-7977 D6; GS-7977 D6; Sofosbuvir-d6; (2'R)-2'-Deoxy-2'-fluoro-2'-C-methyluridine-5'-[Phenyl-(S)-alaninyl] phosphate D6; PSI-7977 (D6); GS-7977 (D6); Sovaldi D6 (labeled analog)
EINECS	Contact for details

Quality Control

Our Sofosbuvir D6 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including NMR, HPLC, and MS, to confirm chemical identity, isotopic purity (D-enrichment), and chemical purity. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data on assay, isotopic purity, and related substances. Our quality commitment ensures the material meets the stringent requirements for use as a certified reference standard in regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry environment. This compound is hygroscopic (moisture-sensitive). For long-term storage, keep desiccated under an inert atmosphere. Allow the sealed vial to equilibrate to room temperature before opening to prevent condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (NMR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98.0 atom % D
Chemical Purity (by HPLC)	≥ 95.0%
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.