Current Edition

Dissolution Specifications for Oral Drug Products (IR, DR, ER) in the USA – A Regulatory Perspective

The development of a dissolution method with suitable specifications is a key part of any oral drug product control strategy. Dissolution testing is a highly important in vitro technique for pharmaceutical dosage form in development
and formulation and, under certain specified conditions, the in vivo dissolution test can be replaced by an in vitro dissolution test. Balamuralidhara V et al. at JSS provide an overview of dissolution specifications and acceptance criteria that should be considered for IR, DR, ER dosage forms.