Learnaboutgmp Community

Specifying limits for non compendial products

hi all,
i had a doubt reg. the drug product if manufactured which is not under any compendial specifications then how to fix the limits for assay and dissolution if any? say will it be 90 - 115% or 85 - 110% etc. how to arrive to that value? else is there any regulatory requirement for this?
cheers
astute

[quote=aastute]hi all,
i had a doubt reg. the drug product if manufactured which is not under any compendial specifications then how to fix the limits for assay and dissolution if any? say will it be 90 - 115% or 85 - 110% etc. how to arrive to that value? else is there any regulatory requirement for this?
cheers
astute[/quote]

Dear Aastute
In case of noncompendial products proposed test specifications should be covered and described in development protocol based on the proposed formulation and nature of product. suppose if its a solid dosage form (tablet) wether its a immediate release or sustained release, as per the requirement dissolution profile is developed and recommended. Limits and specifications are adopted most of the time from compendial general chapter guideline. Normally for assay method limit is 90 - 110% but it depends on method validation and active ingredient overages. for example in cephradine oral suspension USP monograph the limit is 90 - 125% that is obviously based on the recovery of analyte from the thick suspension sample and overages for the cephradine known degradation. As far as the regulatory requirements are concerned they demand for the references for the noncompendial molecules for example the molecule should be added and recognized as INN, BAN Etcetc

I m Agreed with Shahid comments