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About related substances in pharmaceutical drugs

Discussions about HPLC, CE, TLC, SFC, and other "liquid phase" separation techniques.

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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

The procedure you have described is good. What is your question?
-- Tom Jupille
LC Resources / Separation Science Associates
tjupille@lcresources.com
+ 1 (925) 297-5374
2 posts Page 1 of 1

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