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About related substances in pharmaceutical drugs

Posted: Fri May 06, 2005 2:28 pm
by Tequila
Dear members of this forum,

I would like to understand more clear the concept of related substances.
For example in captpril maleate and the limits is 1%, It consists in preparing a standard according to the concentration of 1% (w/w) of captopril maleate, the sample 100 times more concentrated and running the analysis three times the retention time of the main peak.
After finishing I have to evaluate summary of the areas corresponding to the secondary peaks, the result not to be more the area of the standard of captopril maleate 1 %. My doubts is knwing if I am doing well or not.
Thanks in advance for your help,

Diego Delmonte

Posted: Fri May 06, 2005 4:58 pm
by tom jupille
The procedure you have described is good. What is your question?