ASSAY limits for products under Stability

Hello Everyone,

I am new to this group.

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

regards,
sajjad

What are the acceptance criteria for BU and CU as per IP for process validation batches in OSD

Dear Sajjad,

Limit is Depends on your specification , Market Requirement and your method validation data

± 5% assay limit is written in ich guidelines from its initial asay

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. …

According to IP the assay limit is 90 to 110 but we should take the standard of 95 to 105 if it deviate e.g 94.5 to 105.5 it should be consider as OOT


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