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).
[note—The 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
USP Theophylline RS Click to View Structure
Disintegration 701: 30 minutes, determined as directed under Delayed-Release (enteric coated) Tablets.
Other requirements— Tablets respond to the Identification tests and meet the requirements for Uniformity of dosage units, Ethylenediamine content and Assay under Aminophylline Tablets.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Domenick Vicchio, Ph.D.
Senior Scientific Liaison
(SM42010) Monographs - Small Molecules 4
Reference Standards RS Technical Services
701 Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison
(GCDF2010) General Chapters - Dosage Forms
USP35–NF30 Page 2177