5’-deoxy-5-fluoro-N-[(pentyloxy)carbonyl]-cytidine tablet content
Publication Date: 2008-Jun-04
The IP.com Prior Art Database
5'-deoxy-5-fluoro-N-[(pentyloxy)carbonyl]-cytidine tablet content
5'-deoxy-5-fluoro-N-[(pentyloxy)carbonyl]-cytidine("CTN") of the following formula
is a fluoropyrimidine carbamate with antineoplastic activity. It is an orally administered systemic prodrug of 5'-deoxy-5-fluorouridine (5'-DFUR) which is converted to 5-fluorouracil. Trade name of the product (tablets) is XELODA®.
CTN is marketed under the trade name XELODA®.
CTN is a white to off-white crystalline powder with an aqueous solubility of 26 mg/mL at 20°C.
The purity of commercial CTN is reported herein.
Sample Preparation of XELODA®:
Operating in a glove-box three tablets of XELODA® were grinded. The mixture obtained was then accurately weighed to prepare a solution of about 0.6 mg/mL of CTN (about 80 mg in a 100ml volumetric flask). The weighed mixture was diluted with diluent and, after sonication, filtered trough a 0.45 μm membrane filter (the first 5 mL of solution were disregarded).
The clear solution obtained was injected in an HPLC instrument.
Batch PURITY% Imp. rrt 0.18
U8202 99.68% 0.10% <0.02% 0.22% <0.02% XELODA®
U3031 99.67% 0.14% <0.02% 0.19% <0.02%
Imp. rrt 0.19
Rel.Comp. B Imp. rrt 0.95
Imp. rrt 1.11
The identity of the above impurities as provided by the USP is a...