Welcome to the USP 467 Discussion Forum

4 posts / 0 new
Last post
Dr. Analytical
Dr. Analytical's picture
Welcome to the USP 467 Discussion Forum

The new USP 467 guidelines cross multiple disciplines, but we hope to use this forum as a starting point for discussion on the many issues involved. Post your ideas, comments, and questions on the instrumentation, procedures, and interpretation. Let the fun begin!

Sangram
Sangram's picture
yes lets starts with HPLC!

yes lets starts with HPLC!

jocelyn
jocelyn's picture
Hello Dr. Analytical!

Hello Dr. Analytical!
I would like to ask for your help and opinion regarding the latest guidelines on the conduct of Uniformity of Dosage units. Re: the conduct of Content uniformity. The entry of correction factor here, I want to ask about your understanding on the meaning of the weight of the "drug substance' in the formula CF=W/P?
Some analysts understand it to be the weight of the whole dosage unit wheras others have the understanding that it is the amount of the assayed substance in each dosage unit.
Hope to receive reply from you. thanks in advanced.

Dr. Analytical
Dr. Analytical's picture
Jocelyn:

Jocelyn:
(Nice picture choice!)
Do you have a specific USP method that you are asking about?  If you have the Name, I will be able to give a better answer.
In general, the answer will depend on what is being measured, and why.  If you are doing Content Uniformity, you need to know the amount of active in the tablet/solution/etc.  This may be expressed as mg/tablet, mg/mL, %, or a number of other units.  I generally see the total formulation weight as being the value in the denominator. However, if you are doing purity, then it is based on the weight of active that was measured.
I hope this helps.  If not, write back with some more information.