Reverse engineering: Separate, Identify, Quantify and Think!

team brain reverse

Reverse engineering or deformulation, can be used for various purposes: preparing for generica production of pharmaceuticals, counterfeit investigations, batch-to-batch analysis and of course for understanding where and in what phase your ingredients are partitioning.

In order to be successful one needs not only a set of complementary analytical methods and techniques but as important is patience, creativity and a realization to tread carefully. This is because in order for ingredients to be quantified, they almost always first have to be separated out from the formulation. As you separate you must be absolutely certain you are not changing your ingredient and that you get it all out. Thus, reverse engineering is as much about separation and double-checking the identification as it is quantification. Separating might not be as fun to talk about as NMR, HPLC with cool detectors, DSC or Raman and FTIR… but without the proper ways and order to extract, precipitate, filter and centrifuge, your analysis will be wrong and the math will not add up.

In our lab, we use a combination of “colloidal handles” and analytical tools to tread carefully and creatively based on our understanding on how ingredients in formulated products interact. Using this understanding we also know what we can do to take them apart and what it means to them when we filter, centrifuge and precipitate. So yes, we use NMR, HPLC (we love the ELS detector), DSC, Raman and FTIR (and more) but first we separate and before that – we think.

It takes a special team to succeed, because you need a combination of detective skills, analytical nitty gritty, creativity and grit… we have succeeded four times with complete deformulation tasks (at time of writing) so we dare say – we are that special team.

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