Category
Gemcitabine
CAS Number
114248-23-6
Molecular Formula
C9H10F2N2O5
Molecular Weight
264.2 g/mol
Synonym

1-(2-deoxy-2,2-difluoro-beta-D-erythro-pentofuranosyl)pyrimidin-2,4(1H,3H)-dione;2′-Deoxy-2′,2′-difluorouridine;

Keywords
Impurities
Metabolites.
bases and related reagents
Nucleotides
Stable isotopes
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Purity:

Above - 95.0%

Technical Data:

We will provide complete documentation support for every Standard Material. All analytical reports such as ¹H NMR, ¹³C NMR, Mass, FT-IR, HPLC Purity/GC Purity/QNMR Purity, Water content by KF/ Loss on Drying/TGA (Thermo-gravimetric Analysis). Certificate of Analysis with potency report. Each Standard Material SER (Structure Elucidation Report) with NMR, Mass, IR spectral interpretation. This whole analytical document can be included in eCTD, ANDA, DMF submissions to regulatory agencies.

Gemcitabine EP Impurity C is a recognized degradation or synthetic impurity of Gemcitabine listed in the European Pharmacopoeia (EP), and its identification and quantification are essential in quality control to ensure the drug’s purity, safety, and regulatory compliance.