Page 1 of 1
Impurities in DS and DP
Posted: Mon Mar 01, 2021 7:46 pm
by Kina83
Hello everyone,
I have an HPLC method for the analysis of impurities in API, do you think I can use the same method for the analysis of impurities and degradation products in Drug Product?
Thank you very much in advance
Re: Impurities in DS and DP
Posted: Tue Mar 02, 2021 4:07 am
by vmu
It depends on the composition of the particular drug product. Maybe you can, maybe you can't.
Re: Impurities in DS and DP
Posted: Tue Mar 02, 2021 6:20 pm
by Kina83
And where to start? How to know what impurities can be generated? Can there be different impurities in the API than in the final product? How to fulfill the lCH? Thanks so much for any help
Re: Impurities in DS and DP
Posted: Tue Mar 02, 2021 8:42 pm
by vmu
And where to start? How to know what impurities can be generated? Can there be different impurities in the API than in the final product? How to fulfill the lCH? Thanks so much for any help
The impurities originating from the API (API related compounds) in the drug product are usually the same as they are in the API. However, a few new API related compounds can result form the drug manufacturing process (additional treatment of the API in a mixture with excipients can lead to new degradation products). This is one side of the problem.
The other (usually the main) side of the problem is to develop the analysis method with sufficient selectivity. For an API, it is sufficient to separate the main compound and its impurities. For a drug product, it is also necessary to separate the excipients from the compounds of interest.
Re: Impurities in DS and DP
Posted: Wed Mar 03, 2021 4:11 pm
by tom jupille
To elaborate a bit on vmu's reply:
- you will have to fully validate the new method.
Your existing method may provide a starting point. You could run the existing method on the API, on a placebo (final product minus the API) and on the final product and look for differences. That should give you some idea what you are up against.