I am having few queries regarding Assay,
1st Maximum Assay range allowed to product in release and stability specification
2nd What Assay range can be applied to Phenylephrine HCl in Tablet formulation
Everything depends on which pharmacopeia your following for assay test, IP, EP, USP, JP ext… and u most follow the same for stability too…
99.0 to 101.0 is best… it depends on purity, lod, MC and ash of the product. …