Dear E-Drugers,
Some months ago we received complaints from our clinicians in
different health institutions about a drug inefficacy. We tried its
compliance to British Pharmacopoeal specifications. It passed all the
tests. Our next move was to question its bioavilability and tested it
for dissolution from the U.S.P. - 95 (as the latest B.P publication
at our hand 1992 doesn't specify dissolution test for the product).
The drug failed to pass the limit.
The supplier was then informed that the drug has failed to pass the
dissolution test, according to U.S.P. 95. However, the replay they
sent to us was that the drug passed all the tests (without conducting
dissolution test) of the B.P which does't specify dissolution test.
Though the label of the product specifies B.P. and the B.P doesn't
include dissolution test, can't we prove the failure of the drug by
undergoing tests from the U.S.P. specifications if the test we want
to be undertaken is not specified in the monograph the product's label
claims? Any one who can give us his/her comment on the above will be
highly appreciated.
Fitsumbirhan G. Araya
Ministry of Health
Department of Pharmaceutical Services
Drug Quality Control Laboratory
Asmara
Eritrea
E-Mail: qconlab@eri.healthnet.org
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