Theophylline Sodium Glycinate Oral Solution

» Theophylline Sodium Glycinate Oral Solution contains an amount of theophylline sodium glycinate equivalent to not less than 93.0 percent and not more than 107.0 percent of the labeled amount of anhydrous theophylline (C7H8N4O2).

Packaging and storage— Preserve in tight containers.

—

USP Theophylline RS

Labeling— Label Oral Solution to state both the content of theophylline sodium glycinate and the content of anhydrous theophylline.

Identification— Mix a volume of Oral Solution, equivalent to about 500 mg of theophylline, with 10 mL of 6 N ammonium hydroxide, and evaporate on a steam bath to a volume of about 20 mL. Neutralize with 6 N acetic acid to litmus, and cool, with stirring, to about 15

. Collect the precipitate on a filter, wash with cold water, and dry at 105

for 4 hours: the theophylline so obtained melts between 270

and 274

, the procedure for Class I being used (see Melting Range or Temperature

741

), and meets the requirements for Identification test B under Theophylline Sodium Glycinate.

791

: between 8.3 and 9.1.

Alcohol content, Method II

611

: between 17.0% and 23.0% of C2H5OH.

Assay—

Buffer solution, Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system— Prepare as directed in the Assay under Theophylline.

Assay preparation— Transfer an accurately measured volume of Oral Solution, equivalent to about 220 mg of theophylline sodium glycinate, to a 100-mL volumetric flask, dilute with water to volume, and mix. Transfer 10.0 mL of this solution to a 100-mL volumetric flask, add 20.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix.

Procedure— Proceed as directed for Procedure in the Assay under Theophylline. Calculate the quantity, in mg, of anhydrous theophylline (C7H8N4O2) in each mL of the Oral Solution taken by the formula:

(1000C/V)(RU / RS)

in which V is the volume, in mL, of Oral Solution taken, and the other terms are as defined therein.

Auxiliary Information— Please check for your question in the FAQs before contacting USP.

Topic/Question	Contact	Expert Committee
Monograph	Mary S. Waddell Scientific Liaison 1-301-816-8124	(SM42010) Monographs - Small Molecules 4
Reference Standards	RS Technical Services 1-301-816-8129 rstech@usp.org

USP35–NF30 Page 4832

Pharmacopeial Forum: Volume No. 28(2) Page 378