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- Posts: 1
- Joined: Mon Jan 21, 2019 11:19 am
My name is Melissa and I'm writing from Italy.
I am a new entry and I wish I could give my support to anyone who needs it.
But, at the moment, I need a small support: in USP <621>, in the section Sistem suitability, it is said that "Unless otherwise specified in the individual monograph, data from 5 replicated injections are used to calculate the RSD, if the requirement is <=2.0%; data from 6 replicated injections are used if the RSD requirements is >2.0%.
My question is: where does the requirement of 2.0% come from?
Going on reading, it is said that for the assay of a drug substance monograph, if not specified, for RSD rerquirement there is a specific table (equal to that of Eur Ph 2.2.46)... but I cannot find the requirement of 2.0%...
And which is the RSD requirement for the assay of a drug substance without monograph?
I don't understand...
Thanks to everyone who will answer to my question!
Melissa