Paul Lefebvre
July 22, 2016
“The stability indicating method is the gold standard for figuring out what’s what. That’s what the customer is using to identify and quantify all the impurities that they have. What we do is we kind of squish everything together, process a lot of material really fast, and chop it up. Then we take the pieces and we analyze them by the gold standard. And, we see what’s in each one of the buckets that we collect.
At that point, from that rapid first step, we can move on to the next step, and determine where we are, and what process we want to go to isolate the impurity. Because we removed of the 99% API, we went from working with a hundred grams of material to working with a hundred milligrams of material. Now you can run preparative HPLC, and it’ll run for a day instead of two weeks.
Within a week we’re done, and you have enriched supply material that’s very low risk to the overall the compound.”
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