Hello can anyone suggest some CAPA for dissolution for rabeprazole 40 mg tab the capsule contain 2 tablet of rabeprazole which is 20 mg each but in our lab analyst drop one tablet in dissolution instead of two tablets and after run in HPLC the result comes half because of one tablet drop in dissolution and OOS occured.
For such a critical step in the dissolution test you can introduce a double-check system when the capsule contents are added in the dissolution medium in all the baskets. In fact, what is the reason of not adding entire capsule in the dissolution medium? Why are you opening the capsule and adding only inner tablets in the dissolution baskets?
Thanks for responding Sir🙏
After discuss with analyst he is not clear about label claim because when performing assay test label claim is used 20 mg for calculation but in dissolution test label claim used 40 mg that’s why he use single tablet for analysis.