[Individual and average weight requirements of pharmaceutical preparations].
Authors studied the weight deviations allowed by non-statistically constructed individual and average weight requirements of Pharmacopoeas under consideration of normal Gaussian distribution. Normality was examined on a given suppository product and has been established, that in this case theoretically the hypothesis of normal distribution is not valid. For this reason deviation characteristics calculated according to the severest and the lightest Pharmacopoean requirements have been presented, i.e. the lower limit (if the deviation is less than this limit, the preparation meets the requirements by all means), and the upper limit (if the deviation is larger than this limit, the preparation definitively does not meet the requirements) respectively. Moreover, deviation characteristics calculated for continuous Gaussian distribution and for discrete distribution with few elements (representing a good approximation of the former) are given in the paper. On the basis of these results authors suggested to modernize the requirements of Pharmacopoeas and to continue research work in this direction.
Nagy
T
T
Egis Gyógyszergyár Lacta Tápszergyára, Körmend.
Pataki
K
K
D004304:Dosage Forms / Q000592:standards*; D006814:Hungary; D010602:Pharmacopoeias as Topic; D012016:Reference Values
D004304:Dosage Forms
Gyógyszerkészítmények egyedi és átlagtömeg elöírásairól.