PharmPK Discussion - Determination of toxicity of a difficult to isolate impurity

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On 16 Dec 2004 at 09:39:16, Nisha K are (nishavenkatesh.-a-.yahoo.co.in) sent the message


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Hello Forum,

What can be done when an impurity in an API is very difficult to
isolate in a stable form and its effects (toxicity) if any has to be
determined using animals?

Could anyone give me any information?

Nisha. K.R.

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On 19 Dec 2004 at 07:46:29, Ofer.Spiegelstein.-at-.teva.co.il sent the message


The following message was posted to: PharmPK

Hello Nisha,
You are essentialy looking into qualifying the impurity, and so in your
case I believe there are two options. But, first of all as you probably
already know you must identify the chemical structure of the impurity
(level for identification is lower than the level for qualification).
Once
you've done that you can:

1. Have it synthesized de novo for toxicity assesment.
2. Increase its level by forced degradation and then perform the
toxicological assesment in comparison to the clean chemical.

Ofer

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