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RegisterUse of pro-drug instead of active [Bioanalytics]
posted by Helmut 
– Vienna, Austria, 2012-08-05 03:26 (4682 d 01:07 ago) – Posting: # 9038
Views: 4,649
Hi Ionsource,
great nick!
You are right. This would not work. Candesartan cilexetil is much more lipophilic and has no relationship to candesartan in extraction and chromatography.
This is nonsense, forget it. FDA claims that the guidance is under revision for years. High times to sweep things like that out. You will not find such a crazy statement in the European guideline.
If you dont’t have candesartan, ask a friend in the organic chemistry lab to hydrolyze the ester. A little bit hydrochloric acid in methanol on the reflux should do the job pretty fast and complete. SCNR.
great nick!
❝ 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…
You are right. This would not work. Candesartan cilexetil is much more lipophilic and has no relationship to candesartan in extraction and chromatography.
❝ […] 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?
This is nonsense, forget it. FDA claims that the guidance is under revision for years. High times to sweep things like that out. You will not find such a crazy statement in the European guideline.
If you dont’t have candesartan, ask a friend in the organic chemistry lab to hydrolyze the ester. A little bit hydrochloric acid in methanol on the reflux should do the job pretty fast and complete. SCNR.
—
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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Use of pro-drug instead of active Ionsource 2012-08-04 13:07
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Use of pro-drug instead of activeHelmut 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 activeHelmut 2012-08-05 01:26
Ing. Helmut Schütz