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Uniformity of Dosage Units in Pharmaceutical Anaysis
Posted: Wed Jun 20, 2012 11:10 am
by StephenO
When calculating the AV value of 10 samples is it acceptable for the test to pass the AV less than 15 acceptance value, while some or all of the results actually show out of specification results for the assay limits.
Thanks in advance
Re: Uniformity of Dosage Units in Pharmaceutical Anaysis
Posted: Wed Jun 20, 2012 2:14 pm
by phucto
I don't understand what are you asking for? For Uniformity of unit dosage, please refer to USP
Re: Uniformity of Dosage Units in Pharmaceutical Anaysis
Posted: Wed Jun 20, 2012 4:32 pm
by StephenO
If you have +- 5% limit for the Assay limit. and in the UDU you have individual results which are giving results outside the 95% to 105% of the nominal. example 107% 108% is this acceptable if the AV value is still less than 15 even though the result looks to be high in content.
Re: Uniformity of Dosage Units in Pharmaceutical Anaysis
Posted: Thu Jun 21, 2012 10:02 am
by HPLCaddict
Yes it is acceptable. According to EP, the ONLY thing to look for at content uniformity is the acceptance value (for L1!). Individual values may be outside the range of assay specifications. 95% to 105% is the specification for mean assay (meaning of a homogeneous sample), this has nothing to do with UDU.
This is only true for Level 1 (10 units), though. If you don't pass and have to go to level 2 (30 units), every single units must be in the range of (1-L2)x0.01M and (1+L2)x0.01M (usually 75 - 125%).