By Anonymous on Friday, January 3, 2003 - 09:51 am:
I have method for determining mono- and disaccharides in cell culture media and must validated the method. I am using a Dionex IC with pulsed amperometric detection. Cell culture media is a complex mixture (there can be 40 - 80 components) of amino acids, vitamins, sugars, inorganic salts, and organic acids (e.g. pyuvate, citrate). I am pretty clear on what I must do for linearity, accuracy, precision, LOD, and LOQ, but I am a bit confused about specificity. What tests must I run to demonstrate specificity for the assay?
By Anonymous on Friday, January 3, 2003 - 02:45 pm:
Specificity usually involves degradation studies to determine if the method will be able to accurately analyze your analyte of interest. In your case are you quantifying your mono and disaccharides or using the method for aulitative purposes?
By Anonymous on Friday, January 3, 2003 - 02:45 pm:
qualitative purposes? Sorry for the misspelling.
By Anonymous on Monday, January 6, 2003 - 04:50 am:
As I understand your question that you determining mono and disaccharides in cell culture media, if you are looking for mono and disaccharides only in your matrix in that case you can do is if you can preapred placebo without mono and disaccharides and look for no interference at the peak of mono and disaccharides
and If you can not prepared placebo than how will you established peak you geting is of mono and disaccharides only and no other component interfering with your peak of intrest.
By Anonymous on Monday, January 6, 2003 - 09:28 am:
Anonymous 1 - We are using the method to quanitify the mono- and disaccharides. Are the degradation studies done in the complete media or can this be done with just the mono- and disaccharides of interest?
Anonymous 2 - It sounds like a can demonstrate specificity by showing there are no peaks at the retention time of the mono- and disaccharides in a sample of the media that is prepared with all the components except the sugars. Would it also be necessary to do the degradation studies?
Thanks to both for your help. I really appreciate it.
By Anonymous on Tuesday, January 7, 2003 - 05:20 am:
The extent of the specifity depends on how you are going use the method after validation: e.g. the number of different sample sources, samples from controlled or uncontrolled enviroment?
If you have many sources of samples you should try to analyse as many as possible and check for interfering peaks.
Degradation studies wouldn't hurt if you have uncontrolled enviroment.
By Anonymous on Monday, April 5, 2004 - 03:59 am:
Can I get HPLS method for Alendronate sodium ?
If some one help me regarding this i very much greateful to him