what is meant by artwork review and handling procedure with
an example?
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using of chemical standards in HPLC he customer gave 100.2% what potency i will use this potency in hplc?
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If calibration of 12 bowl dissolution apparatus does not meets single stage procedure, how can u proceed calibration?
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Anyone have any idea when to conduct Uniformity of Weight (UOW) and when need to conduct Uniformity of Dosage Units (UOD) or when need both? I read BP it only said if average weight < or = 0.04g then just conduct UOD, no need UOW. Under UOD section, it doesnt say when need to conduct UOD but just said UOD got two type, one is Mass Variation (MV), another is Content Uniformity (CU) and under what conditions to conduct them. For USP, no UOW section, only got UOD section.
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how to calculate potency of working standard by using mass balence method & this calculated potency is on as basis or on anhydrous/ dried basis
IF We have to autoclave two chamber of media one having temp 100 c and onather at RT,which one get autoclaved first?
What is the basic requirement for preparing drug master file , like EDMF , USDMF ?