Collaborative study of the USP dissolution test for prednisone tablets with Apparatus 2.
Five lots of prednisone tablets that disintegrate within 5 min were collaboratively studied by 11 laboratories using USP Apparatus 2 under carefully controlled conditions. One lot gave complete dissolution. The reproducibility and repeatability of Apparatus 2 for the four lots still dissolving at the end of the test were 2.6 and 1.6% of label claim, respectively, for the 11 laboratories.
D002626:Chemistry, Pharmaceutical / Q000295:instrumentation; D010602:Pharmacopoeias as Topic; D011241:Prednisone / Q000032:analysis* / Q000592:standards; D012995:Solubility; D013607:Tablets / Q000032:analysis / Q000592:standards; D014481:United States
D013607:Tablets; D011241:Prednisone