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RegisterUse of pro-drug instead of active [Bioanalytics]
Hi everybody
Is it appropriate to use Candesartan cilexitil instead of candesartan (unesterified) to develop analytical method for candesartan. I personally believe it shouldn't be done but I got confused when I had read in FDA guidance the following text
"If possible, the reference standard should be identical to the analyte. When this is not possible, an established chemical form (free base or acid, salt or ester) of known purity can be used". how could an ester be used instead?
Please somebody let me know. thanks
Is it appropriate to use Candesartan cilexitil instead of candesartan (unesterified) to develop analytical method for candesartan. I personally believe it shouldn't be done but I got confused when I had read in FDA guidance the following text
"If possible, the reference standard should be identical to the analyte. When this is not possible, an established chemical form (free base or acid, salt or ester) of known purity can be used". how could an ester be used instead?
Please somebody let me know. thanks
Complete thread:
- Use of pro-drug instead of activeIonsource 2012-08-04 13:07
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Use of pro-drug instead of active Helmut 2012-08-05 01:26
- Use of pro-drug instead of active Ionsource 2012-08-05 14:17
- Sources of reference standards Helmut 2012-08-05 15:35
- Sources of reference standards Ionsource 2012-08-06 06:27
- Sources of reference standards Helmut 2012-08-05 15:35
- FDA guidance Ohlbe 2012-08-08 23:53
- Use of pro-drug instead of active Ionsource 2012-08-05 14:17
- Use of pro-drug instead of active Helmut 2012-08-05 01:26
Ing. Helmut Schütz