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头孢拉定胶囊英国药典BP2013UpdatedB.doc


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British Pharmacopoeia Volume III
Formulated Preparations: Specific Monographs
Cefradine Capsules
General Notices
the plates parallel to the airflow, cool for 15 minutes protected from light and examine in daylight.
MOBILE PHASE
3 volume of acetone, 80 volumes of disodium hydrogen orthophosphate and 120 volumes of acid.
CONFIRMATION
The principal spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2).
TESTS
Dissolution
Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1.
TEST CONDITIONS
(a) Use Apparatus 1, rotating the basket at 100 revolutions per minute.
(b) Use 900 mL of acid, at a temperature of 37°, as the medium.
PROCEDURE
(1) After 45 minutes withdraw a 10 mL sample of the medium, filter and dilute the filtered solution, if necessary, with sufficient acid to produce a solution expected to contain about % w/v of Cefradine. Measure the absorbance of the filtered sample at the maximum at 255 nm, Appendix II B, using acid in the reference cell.
(2) Measure the absorbance of a % w/v solution of cefradine BPCRS in acid using acid in the reference cell.
DETERMINATION OF CONTENT
Ca

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