USP Feedback

[shaun78]

Is anyone aware of a platform for which scientists can send the USP feedback for monographs currently in print?

Note that I am not referring to the Pharmacopeial Forum where people are allowed to comments on proposed changes to monographs.

Thanks in advance if such a thing exists.

[scottythree]

On the USP online version each chapter/monograph has an owner with their email contact provided at the bottom of the chapter/monograph for questions. It has been a long time since I have used the old style book so I can not answer for that.

[Consumer Products Guy]

I'll volunteer that I have contacted the USP representative connected with a Monograph. Responses have typically been "just follow the Monograph as written" or "see <621>".

When I questioned what "standardize frequently" really meant in the Volumetric Solutions chapter, asked if that meant every 10 minutes, every 10 days, every 10 weeks, whatever, and whether such standardizations needed to be done in singleton, duplicate, or triplicate 9and therefore how close such results should be), they just got mad at me.

So I still didn't have any answers, glad I'm now retired.

The one thing they helped with was for how to assay for purity of incoming ethyl alcohol (to be used to manufacture OTC hand sanitizer), as not in the monograph. USP replied in E-mail to use density - not in the monograph, so I just printed that out and pasted that in my lab book, made my boss happy.

[shaun78]

I have contacted the monograph owner; in my opinion the owner is not able to make their way through the monograph themselves.

In reaching out to industry it has become my impression that industry does not understand the monograph, and thus is not following it.

In reaching out to manufacturers of this product it has become my impression that the manufacturers do not understand the monograph and are not following it.

I think it foolish that the USP expects an analytical chemist to be able to perform non-linear differential equations and model fitting analysis to solve for five variables in a single equation.

The USP needs to know that they have failed miserably if industry can not interpret their instructions and even their own can't give guidance as to how to proceed.

I do not wish to name names or try to get anyone in trouble for claiming to follow this monograph and then not. However, the USP does need to be informed that they have missed the boat on this one.

For what it is worth, I am referencing molecular weight determinations of dextrans.

[James_Ball]

I understand what you are saying. Ever look at the USP test for Heavy Metals?

It is a simple extraction and color change reaction and visible color indicates presence of heavy metals, except that half of the metals on the list will not produce the color change. So the sample could be contaminate with one of those metals and still give a negative result. This has been a known problem for many many years but the test is still what is listed for use to ensure safety of materials. They are just now getting around to approving ICPOES and ICPMS for analysis of heavy metals, though most manufacturers that are serious about making sure their products are free of heavy metals have been confirming by these methods for many years.