Analytical meth dev w/o impurities [August 16,2004]
Posted: Sun Aug 29, 2004 6:57 pm
By Bhaskar on Monday, August 16, 2004 - 11:11 pm:
Dear All,
We in Analytical R&D, need to develop the meyhods for the organic intermediates and Active pharmaceutical ingradients. We develop the methods during the feasibility studies of synthytic process,when no impurities available and there may be possibility to change the process again. So there is possibility to get the new impurities.
In this situation how should we develop a method which can resolve all the impurities in the changed process also. Is there any guidelines to effective method development?
Can you please give some tips on the topic.
Thanks in advance
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By popeye on Tuesday, August 17, 2004 - 02:38 am:
How can you predict the process impurities generated by any unknown process? You do not have any other choice, but to refine and modify the method as and when the process is changed and new process impuruties are generated.
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By Jerry G. on Tuesday, August 17, 2004 - 06:12 am:
Generate some impurities. An LC method should be stability indicating meaning it should be able to detect impurities when the compound becomes unstable. Stress your sample with heat, acid, base, peroxide, etc. You should see some impurities if not your method needs more work!!
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By popeye on Wednesday, August 18, 2004 - 04:49 am:
There is no point in doing these forced degradation studies, if the process is going to be changed. The method can work if the route remains the same, but if the route is changed, then you have to modify the method.
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By Raman.N on Wednesday, August 18, 2004 - 04:53 am:
Hay!
Still you are in the same situation. Very bad.
Ofcourse you can do like inject the innovators sample if available and compare the impurity profile, but you have to select different methods and techniques.And as Mr. Jerry G said you have to generate impurities by stress
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By popeye on Friday, August 27, 2004 - 04:20 am:
He is talking about APIs and intermediates... Not finished products. Where will you get the innovator sample and compare the impurities?
Dear All,
We in Analytical R&D, need to develop the meyhods for the organic intermediates and Active pharmaceutical ingradients. We develop the methods during the feasibility studies of synthytic process,when no impurities available and there may be possibility to change the process again. So there is possibility to get the new impurities.
In this situation how should we develop a method which can resolve all the impurities in the changed process also. Is there any guidelines to effective method development?
Can you please give some tips on the topic.
Thanks in advance
-------------------------------------------------------------------------------------------------------
By popeye on Tuesday, August 17, 2004 - 02:38 am:
How can you predict the process impurities generated by any unknown process? You do not have any other choice, but to refine and modify the method as and when the process is changed and new process impuruties are generated.
-------------------------------------------------------------------------------------------------------
By Jerry G. on Tuesday, August 17, 2004 - 06:12 am:
Generate some impurities. An LC method should be stability indicating meaning it should be able to detect impurities when the compound becomes unstable. Stress your sample with heat, acid, base, peroxide, etc. You should see some impurities if not your method needs more work!!
-------------------------------------------------------------------------------------------------------
By popeye on Wednesday, August 18, 2004 - 04:49 am:
There is no point in doing these forced degradation studies, if the process is going to be changed. The method can work if the route remains the same, but if the route is changed, then you have to modify the method.
-------------------------------------------------------------------------------------------------------
By Raman.N on Wednesday, August 18, 2004 - 04:53 am:
Hay!
Still you are in the same situation. Very bad.
Ofcourse you can do like inject the innovators sample if available and compare the impurity profile, but you have to select different methods and techniques.And as Mr. Jerry G said you have to generate impurities by stress
-------------------------------------------------------------------------------------------------------
By popeye on Friday, August 27, 2004 - 04:20 am:
He is talking about APIs and intermediates... Not finished products. Where will you get the innovator sample and compare the impurities?