-
- Posts: 27
- Joined: Sat Jan 10, 2009 11:01 am
Thanks
Tina
Advertisement
Discussions about HPLC, CE, TLC, SFC, and other "liquid phase" separation techniques.
In short, I would not recommend that approach (error of 30%) when doing pharmaceutical impurities (I think martinamarie does that) with regard to the ICH Q3 A+B guidelines trigger points for identification and qualification (clinical trials) of impurities.Tina, if you only want to estimate the amount of the impurity, I think you can choose the best wavelength between both compounds.
If you already know what impurity is , another alternative is to look for a standard that is most similar as possible to your impurity and quantify it. Someone would criticize me, but if your impurity is about 0.1 % for example and you are only estimating, if you have an error of 30% in the amount of impurity, Ãs not a big deal if the result is 0.10 or 0.13% when you are estimating.
I hope it helps,
Marcelo
Separation Science offers free learning from the experts covering methods, applications, webinars, eSeminars, videos, tutorials for users of liquid chromatography, gas chromatography, mass spectrometry, sample preparation and related analytical techniques.
Subscribe to our eNewsletter with daily, weekly or monthly updates: Food & Beverage, Environmental, (Bio)Pharmaceutical, Bioclinical, Liquid Chromatography, Gas Chromatography and Mass Spectrometry.