Category
Gemcitabine
CAS Number
95058-85-8
Molecular Formula
C9H11F2N3O4
Molecular Weight
263.2 g/mol
Synonym

 4-amino-1-(2-deoxy-2,2-difluoro-a-d-erythro-pentofuranosyl)pyrimidin-2(1H)-one ;1'-Epi Gemcitabine; 4-Amino-1-(2-deoxy-2,2-difluoro-α-D-erythro-pentofuranosyl)pyrimidin-2(1H)-one; 4-Amino-1-((2S,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl)pyrimidin-2(1H)-one;

Keywords
Metabolites.
Impurities
bases and related reagents
Nucleotides
Pharmaceutical Standards
Fine Chemicals
Intermediates
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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 B is a specified degradation or synthetic impurity of Gemcitabine as described in the European Pharmacopoeia (EP), monitored in pharmaceutical quality control to ensure the drug’s safety, purity, and compliance with regulatory standards.