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November 28, 2012
Every Tiny Detail
Posted by Derek
Via Chemjobber, we have here an excellent example of how much detail you have to get into if you're seriously making a drug for the market. When you have to account for every impurity, and come up with procedures that generate the same ones within the same tight limits every time, this is the sort of thing you have to pay attention to: how you dry your compound. And how long. And why. Because if you don't, huge amounts of money (time, lost revenue, regulatory trouble, lawsuits) are waiting. . .
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1. Anonymous on November 28, 2012 3:59 PM writes...
"An efficient synthesis of the known 1-(1-methylpiperidin-
Permalink to Comment4-yl)piperazine 4 was developed" looks wrong to me.....
2. Helical_Investor on November 28, 2012 4:08 PM writes...
#1 - There are two links in the first part of Derek's post.
As to the Chemjobber post, yeah, 'never put anything flush on the metal floor of the drying oven' is an early lesson everyone should learn prior to industry, but don't always.
Zz
Permalink to Comment3. processchemist on November 29, 2012 3:48 AM writes...
And in this case there's no problem about particle size distribution variation and polymorphs switch during drying... There's not only the impurity formation problem, but the constant bioavailability issue too...
Permalink to CommentA TGA/DSC analysis can be of great help in setting the drying conditions for products with problems during standard drying (the classical case: "I obtained this wonderful cake of white crystals, why they turned yellow on drying?").
4. Anonymous on November 29, 2012 5:40 AM writes...
for a multi billion dollar market and highly skilled employees this is not really something to brag about... no wait, why again is this kinf of quality and reliability unkown in clinical medicine or IT?
Permalink to Comment5. Optimization colleague on November 29, 2012 7:41 AM writes...
Welcome to the world of process chemistry. Getting into this kind of detailed optimization involves some highly skilled scientific endeavours and strong collaboration between synthetic, physical organic and analytical chemists and engineers. You need to really underestand what's going on and then define conditions where you get the desired product to the desired yield and quality every time. Exciting stuff! And a completley different world to medicinal chemistry...
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