Description

Sofosbuvir Impurity 7 is a structurally defined degradation product and synthetic intermediate used exclusively in the quality control and regulatory compliance of sofosbuvir, a nucleotide analog inhibitor for hepatitis C virus (HCV) treatment. It serves as a critical reference standard for identity confirmation, assay validation, and impurity profiling during pharmaceutical development and GMP manufacturing. Regulatory laboratories, contract research organizations (CROs), and active pharmaceutical ingredient (API) manufacturers rely on this compound to meet stringent ICH Q3B(R3) and USP/EP monograph requirements for residual impurity quantification.

Application

• Primary reference standard for HPLC and UPLC method validation in sofosbuvir API release testing
• Calibration material for quantitative determination of impurity levels per ICH Q2(R2) guidelines
• Spiking agent in forced degradation studies to assess stability-indicating capability of analytical methods
• Qualification standard for identification via LC-MS, NMR, and IR spectroscopy in regulatory submissions (FDA, EMA, PMDA)
• Use in development and verification of dissolution and content uniformity test methods
• Supporting material for root cause analysis during out-of-specification (OOS) investigations in API production
• Reference compound for establishing specification limits in drug master files (DMFs) and CMC sections of NDAs/MAAs
• Training standard for analytical chemists in pharmaceutical quality control laboratories

Basic Information

Product Name	Sofosbuvir Impurity 7
CAS No.	1884385-12-9
Molecular Formula	C22H28F3N5O7
Molecular Weight	531.48 g/mol
Synonyms	(2R,3R,4R,5R)-2-(4-Aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-5-(2,2-difluoroethoxy)-3,4-dihydroxytetrahydrofuran-2-carboxylic acid; Sofosbuvir Related Compound 7; Sofosbuvir Degradant 7; GS-7977 Impurity 7; 2'-Deoxy-2'-α-fluoro-β-C-methyluridine Impurity 7; (2R,3R,4R,5R)-2-(4-Amino-1H-pyrrolo[2,1-f][1,2,4]triazin-7-yl)-5-(2,2-difluoroethoxy)-3,4-dihydroxytetrahydrofuran-2-carboxylic acid; Sofo-Imp-7; Sofosbuvir EP Impurity 7
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request. All batches are tested per USP & EP reference standard protocols, with full traceability to primary certified reference materials. Testing includes identity confirmation (IR, NMR, MS), purity assessment (HPLC-UV, ≥98.5%), and residual solvent screening (GC). Manufactured under ISO 9001-certified quality management systems and compliant with ICH Q5, Q7, and Q9 guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at 2–8°C under inert atmosphere (nitrogen or argon) to prevent oxidation and degradation. Keep away from moisture and strong alkalis. Handle in a controlled environment with low humidity (<30% RH) and minimal exposure to ambient light.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.5%
Related Substances (HPLC)	Single impurity ≤0.3%; Total impurities ≤0.5%
Residual Solvents (GC)	Meets ICH Q3C limits
Water (KF)	≤0.5%
Heavy Metals	≤10 ppm

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