Transcription of Two-Tier Dissolution Testing*
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Two-Tier Dissolution Testing*
Two-Tier Dissolution Testing* In early t 993, the USP S ubcomrnittce o n Disso-lution and Bioavailabili ty (DBA) decided that the soft gelatin capsules Dissolution test exemp-tion in the USP <711> Dissolutio n General C ha pter sho uld be de leted. It was determined that there s hould be" Dissolution test for all types of capsules. For capsules where a dissolutio n test could not be develo ped, a rupture test was pro-posed in Pharmacopeial Forum (PF), the revision journ a l of th e USP. In July 1993, at a DBA Subcommittee meeting it was decided dlat "aged capsules" that did not pass the Dissolution test would undergo a second disso-lutio n test using m edium containing enzyme. Ilowcvcr, this was only .111owed providing that t he re was no evidence t hnt the bioavailabilty of the capsules had been adversely changed. The ch ange was proposed in the USP <71 I> Dissolu-tion General C hapte r in the Previews section o f the PF in early 1994.
Two-Tier Dissolution Testing ... continued mediulll, as appropriate. Pepsin should normally be ridded ro ::lcidic media, while p:1I1cre,Hin is
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