Aminophylline Delayed-Release Tablets
» Aminophylline Delayed-Release Tablets contain an amount of aminophylline equivalent to not less than 93.0 percent and not more than 107.0 percent of the labeled amount of anhydrous theophylline (C7H8N4O2).
[noteThe ammoniacal odor present in the vapor space above Aminophylline Delayed-Release Tablets is often quite strong, especially when bottles having suitably tight closures are newly opened. This is due to ethylenediamine vapor pressure build-up, a natural condition in the case of aminophylline. ]
Packaging and storage Preserve in tight containers.
Labeling Label the Tablets to state the content of anhydrous theophylline.
USP Reference standards 11
Disintegration 701: 30 minutes, determined as directed under Delayed-Release (enteric coated) Tablets.
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 2177