Guidence for assay limit for Different strengths of same formulation

[himanshu narang <yanky_boyz@yahoo.com>]

Hello forum
may i request to have the guidance about the
regulatory requirement for the assay limit for
different strengths of same active molecule in any
formulation. As with the uniformity of weight the
limit could be more stringent or relaxed in case of
lower or higher strength or have an IN HOUSE Limit !
Regards


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Himanshu Narang
Officer-Quality Assurence

Macleods Pharmaceuticals Limited