In house ref standar

Hi everyone,
I´m looking for some official procedure to apply when you have to give a Potency to a drug that isn´t in any pharmacopeia.
I found that some people does a titration as you have no official standard reference, but this unspecific so you migth have the value of drug + impurities. Others use a Mass balance like 100- % Water - % organic impurities - % inorganic impurities - % residual solvents. I think this is the better way to have an approach. Do you know which is de FDA criteria?
Thank you in advance. Cynthia

I’d “guess” whatever is based upon good science, and works for the intended purpose. We use two APIs in our finished products for which there is no official USP monograph (triclocarban and pyrithione zinc), so no offical way to assay the incoming API.

For the finished products we sell, we develop and validate our own procedures.

Criteria for mass balance technique for potency determination is

100-(sum of water/LOD and organica and inorganic impurities).

This is addressed in EDQM Guideline
Click on the link to get all edqm main guidelines, select the reference standard guideline for mass balance

Best Regards,
Bujji Reddy Kanchi

Best Regards,
Bujji Reddy Kanchi.

WHO and EDQM Defines the same ,

I would like to attach the reference documents, But here I dont know how to send the documents from this website.

Bujji Reddy K

Dear bujjikanchi, your comment was very helpfull. I found the use of mass balance where you telll me. On ■ Handling and Use of Reference Standards in the OMCL Network PA/PH/OMCL (11) 204 3R

Thanks a lot,