Aminophylline Delayed-Release Tablets, chemical structure, molecular formula, Reference Standards

Aminophylline Delayed-Release Tablets

»Aminophylline Delayed-Release Tablets contain an amount of aminophylline equivalent to not less than 93.0percent and not more than 107.0percent 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 á11ñ— USP Theophylline RS.

Disintegration á701ñ: 30minutes,determined as directed under Delayed-Release(enteric coated)Tablets.

Other requirements— Tablets respond to the Identificationtests and meet the requirements for Uniformity of dosage units,Ethylenediamine contentand Assayunder Aminophylline Tablets.

Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist

Expert Committee:(PA1)Pharmaceutical Analysis 1

USP28–NF23Page 131

Phone Number:1-301-816-8379