It is quite clear in the USP how to handle temperature excursions for
Controlled Room Temperature, as an example.
However, I have found no mention any place about humidity excursions. I
would like to know if anyone out there has justified humidity excursions
for their products. If so, what has been used for extent of the excursion
(%RH and time). What data was used to justify this?
Mark A. Schreiber, Ph.D.
Sr. Manager Pharma Analytics
8180 Bülach, Switzerland
Phone: +41 44 864 5306
Mobile: +41 79 786 0602
Fax: +41 44 864 5353
Mail: [log in to unmask]
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