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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline: Don't miss Derek Lowe's excellent commentary on drug discovery and the pharma industry in general at In the Pipeline

In the Pipeline

« Advice For Those Trying High-Throughput Screening | Main | Roche Repurposes »

November 28, 2012

Every Tiny Detail

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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. . .

Comments (5) + TrackBacks (0) | Category: Analytical Chemistry | Chemical News | Drug Development


COMMENTS

1. Anonymous on November 28, 2012 3:59 PM writes...

"An efficient synthesis of the known 1-(1-methylpiperidin-
4-yl)piperazine 4 was developed" looks wrong to me.....

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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 Comment

3. 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...
A 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?").

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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 Comment

5. 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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