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


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