Description

Psi-7977-13C-D3 is a stable isotope-labeled analog of the antiviral nucleoside phosphoramidate prodrug PSI-7977, specifically incorporating carbon-13 and deuterium atoms. This labeled compound is an essential reference standard and internal standard for quantitative bioanalytical studies, ensuring accurate pharmacokinetic and metabolic profiling. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers engaged in the development and validation of assays for antiviral therapeutics, particularly for hepatitis C virus (HCV) research.

Application

• Bioanalytical Reference Standard: Serves as a certified reference material for the quantification of PSI-7977 (Sofosbuvir metabolite) in biological matrices (plasma, serum, tissue) using LC-MS/MS.
• Metabolite Tracing & Pharmacokinetics: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) studies due to its isotopic label, minimizing interference from endogenous compounds.
• Method Development & Validation: Critical for developing, optimizing, and validating robust analytical methods in compliance with GLP and FDA/EMA guidelines.
• Doping Control & Forensic Analysis: Used as a high-purity calibrant in specialized testing laboratories.
• Stability-Indicating Assays: Supports forced degradation studies and stability testing of pharmaceutical formulations containing related compounds.

Basic Information

Product Name	Psi-7977-13C-D3
CAS No.	2070009-25-3
Molecular Formula	C22H2613C D3FN3O9P
Molecular Weight	Contact for details
Synonyms	PSI-7977-13C-D3; GS-7977-13C-D3; Sofosbuvir impurity-13C-D3; (2'R)-2'-Deoxy-2'-fluoro-2'-C-methyluridine-5'-[Phenyl-(13C-D3)-methoxy-L-alaninyl]phosphate; PSI-7977 (13C-D3); GS-7977 (13C-D3); Isotopically Labeled PSI-7977
EINECS	Contact for details

Quality Control

Every batch of Psi-7977-13C-D3 is manufactured and analyzed under strict quality management systems. We provide comprehensive Certificates of Analysis (COA) that detail isotopic purity, chemical purity, and confirm structural identity using advanced spectroscopic and chromatographic techniques. Our quality commitment ensures the material meets the stringent requirements for use in regulated bioanalysis and pharmaceutical development.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below under an inert atmosphere. Due to its hygroscopic nature, the container should be allowed to reach room temperature before opening to minimize moisture uptake. For long-term storage, keep desiccated.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity	≥ 99.0 atom % 13C; ≥ 98.0 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.