Inhalation Tuesday, December 12, 2017
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Inhalation is the only technical publication devoted exclusively to readers involved in development and production of pulmonary or nasal delivered pharmaceuticals.
 

                                   USP to publish revisions to <5> and <601>;
                               Deadline for comments is March 2013



Following the United States Pharmacopeial Convention's (USP) long-standing
standards-setting process, General Chapter General Quality Tests for Inhalation
and Nasal Drug Products
<5> and General Chapter Performance Quality Tests for
Aerosols, Nasal Sprays, Metered-Dose Inhalers, and Dry Powder Inhalers
<601>
were sent out for a 90-day public comment on July 1, 2011. That comment period
ended on September 30, 2011.

The USP Dosage Forms Expert Committee (EC)—which has oversight for changes
to General Chapters <5> and <601>—met in August 2012 and approved revisions
to General Chapters <5> and <601>, as well as a Stimuli article responding to
comments received by USP on these chapters during the comment period that
ended September 30, 2011. Revised General Chapters <5> and <601> will be
published in Pharmacopeial Forum 39(1) [Jan.-Feb. 2013]. The deadline for
receiving comments will be March 31, 2013.

Inhalation has published a two-part series of articles by representatives of the
International Pharmaceutical Aerosol Consortium on Regulation and Science
(IPAC-RS) offering their opinion on the content and implications of the revised and
new USP Chapters for Aerosols <601> and <5>. The first article was published in
February 2012 and the second article in April 2012.


Critical evaluation of the revised and new USP chapters for aerosols: <601> and <5> [Pharm
Forum 2011; 37(4)]


Significant restriction of the delivered dose uniformity criteria in the revised USP Chapter for
Aerosols <601>




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