Question { Lupin, 10247 }
what is the exact diff betwen the uniformity of weight &
uniformity of content?
Answer
Uniformity of Weight is carried out to get information whether the weight of individual units are having uniform weight or not. It is also used to calculate content uniformity when the from the assay results only when the dosage form which are having Active Pharmaceutical Ingredient more than 25 % of the excipient used in formulation. This is carried out during chemical analysis.
Uniformity of Content is carried out to check the uniform distribution of the Active Pharmaceutical Ingredient of 10 units from the randomly selected units. This test is carried out mainly when the API content is less than 25 % of Total Formulation. This is carried out on Instrumental Analysis ( HPLC ).