We conduct stability at 40C & 75RH for Cefixime capsule and use PVDC for more protection but unfortunately it falls in the accelerated stability although we use the same originator composition.
The API loss reach more than 5% from its initial value and that is consider as stability failure according to EMA stability guidelines, on the other hand we cannot make an overage without justification.
We notice there is swelling in the blister pocket indicate CO2 release.
Hi! Mohammad,
Did you carry out the API characterization? I would suggest to carry out the forced degradation study of the API.
You said that there was swelling in blister pockets.. it could also be due to moisture gain during stability. What is the moisture content of your final bulk powder for filling in capsules? Please keep moisture below 2%. If drying is required then go for drying. Did you use calcium hydrogen phosphate dihydrate as one of the excipient? If yes, then go for anhydrous form of it instead of dihydrate or else you will need to dry your final bulk to a moisture content of less than 2%.
Please also maintain RH below 50% during all stages till packing.
Regards,
Abhishek
Hi! Mohammad,
Did you carry out the API characterization? I would suggest to carry out the forced degradation study of the API.
You said that there was swelling in blister pockets.. it could also be due to moisture gain during stability. What is the moisture content of your final bulk powder for filling in capsules? Please keep moisture below 2%. If drying is required then go for drying. Did you use calcium hydrogen phosphate dihydrate as one of the excipient? If yes, then go for anhydrous form of it instead of dihydrate or else you will need to dry your final bulk to a moisture content of less than 2%.
Please also maintain RH below 50% during all stages till packing.
Regards,
Abhishek
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