I do not know the specific answer on m-cresol for Parenteral use. However, for excipients or materials which may only have a fairly small usage, especially when it is for Parenteral use, many times there are no suppliers interested in making a USP grade according to the specific GMPs that may apply since there is no economic justification for this from the supplier’s perspective.
The pharma users may need to do their own mitigation steps to appropriately justify the use of the grade they can find. This could include various purification steps that they may need to do in some cases but will normally also include some extensive testing, beyond just the tests listed in the USP.
This situation is not uncommon for USP grades intended specifically for parenteral uses. Only a limited set of suppliers may be interested in selling a USP grade for these specialized intended purposes.
Sorry, but there is no easy answer for this.
Regards,
Dave Schoneker
President/Owner/Consultant
Black Diamond Regulatory Consulting, LLC
[email protected]Sent from my mobile device.
Original Message:
Sent: 4/20/2023 1:55:00 PM
From: Robert Jennings
Subject: USP grade m-cresol - parenteral use
Can anyone give me insight into why I can not find a supplier for USP grade m-cresol?
Is there some issue with usage, suppliers, or what?
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Robert Jennings Ph.D.
Consultant
Rob Jennings Consulting
San Diego CA
[email protected]
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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