What makes a good leachable protocol?
This is an area which seems to generate a lot of discussion. Perhaps because there are lots of decisions to make. I'd like to share a few items to consider here.
Are you ready to start a leachable study?
When planning a leachable study a lot of things have to come together. The two fundamentals are samples and a means to test them. Let start with samples, have you a set of samples which represent what you are seeking to achieve. For example, if the samples have been manufactured already how old are they? The leaching process begins the moment the packing materials and the formulation come together and in some instances there maybe loses from the system. So you must be mindful and plan accordingly, its normally the case samples are in short supply so planning the testing should be very aware of this.
Secondly, the tests you will use - Leachable testing is challenging, low detection limits, interference from API and formulation elements together with perhaps incomplete knowledge of the analytes you are seeking all make the development of methods of the analysis quite hard. Therefore, development times can be long and testing the suitability of the methods before entering into a formal validation is a very good idea. All this means the timeline for development can catch some people by surprise and as I said in part one leaching doesn't wait while you develop your methods
