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Mark Jordi has published a series of articles on use of multiple detectors (LC-UV,LC-CAD, GC-FID, GC-MS, LC-MS) as a mechanism to ensure correct relative response factors are used in extractable screening studies as an alternative to very high uncertainty values in setting AETs.

pubmed.ncbi.nlm.nih.gov

Characterization of Extractables and Leachables (E&Ls) is an important aspect of product quality in important fields such as pharmaceuticals, medical devices and food contact materials. The main goal of an E&L study is identification and quantification of those species which may leach from p …

What do people think of this approach?

I am interested in hearing why people choose the solvents they do for their extraction studies. Anybody care to share what they would recommend and why?

Do you think all methods for Extractable and Leachable methods need validation? Can you successfully validate a method without reference standards? How do you test the accuracy of your methods?

What are you looking for from a supplier? How would you rate the current situation, generally are suppliers getting you what you need?

I think is an interesting and varied discussion point. I'd like to hear your opinion. Are people expecting too much of suppliers or not enough. Do you choose materials with E&L in mind or is cost more important. Do you know what to expect from suppliers? Do different kinds of materials and components come with different expectations with regard to extractable information?

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…

What are your top tips or must haves in Leachable studies?

How should you handle the inputs (number of batches - which batches?). What about simulation studies, when do you use them? How do you justify temperature of storage. What length of study do you do?

Please use this forum category to add topics or item which you think ICH Q3E should contain.

I think we should bear in mind the structure of a typical ICH guide and its readability. E&L is a broad topic. How do you produce a worthwhile guidance document and cover each topic in E&L?

As per the name. Come here to post and ask questions about anything around E&L. There no such thing as a stupid question.

It those simple questions that sometimes lead to the most profound discussion. For example, what is an extractable?

We have so many different descriptions for at the moment. It a very open question and the correct answer is all about the context in which it is asked. I think the simplest answer is it is a designed experiment to determine what is present in the sample (typically a component material of a system) which you want to establish identity and amount.

Comments are most welcome

Hope you enjoy the Maven E&L forum. It been created for members to share ideas and questions about all things E&L related😀

You can upload photos and video too if you want. Here an example from me