Oxtriphylline Oral Solution
»Oxtriphylline Oral Solution contains an amount of oxtriphylline equivalent to not less than 90.0percent and not more than 110.0percent of the labeled amount of anhydrous theophylline (C7H8N4O2).
Packaging and storage— Preserve in tight containers.
Labeling— Label Oral Solution to state both the content of oxtriphylline and the content of anhydrous theophylline.
Identification—
A: The retention time exhibited by theophylline in the chromatogram of the Assay preparationcorresponds to that of theophylline in the chromatogram of the Standard preparation,as obtained in the Assay.
B: Place a volume of Oral Solution,equivalent to about 100mg of oxtriphylline,in a 60-mLseparator containing 1mLof glacial acetic acid and 40mLof chloroform.Shake for 1minute,allow the phases to separate,and filter the lower phase through dry cotton into a 100-mLbeaker.Transfer a portion of the chloroform solution,equivalent to about 10mg of oxtriphylline,to a porcelain dish,and evaporate on a steam bath with the aid of a current of dry air to dryness.Add 1mLof hydrochloric acid and 100mg of potassium chlorate,evaporate on a steam bath to dryness,and invert the dish over a vessel containing a few drops of 6Nammonium hydroxide:the residue acquires a purple color.
pHá791ñ: between 6.4and 9.0.
Alcohol content (if present),Method Iá611ñ: between 90.0%and 115.0%of the labeled amount,the labeled amount being not more than 20.0%of C2H5OH.
Assay—
Mobile phase,Standard preparation,System suitability preparation,and Chromatographic system— Prepare as directed in the Assayunder Oxtriphylline Delayed-release Tablets.
Assay preparation— Transfer an accurately measured volume of Oral Solution,equivalent to about 100mg of oxtriphylline,to a 1000-mLvolumetric flask,dilute with water to volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Oxtriphylline Delayed-release Tablets.Calculate the quantity,in mg,of C7H8N4O2in each mLof the Oral Solution taken by the formula:
(180.17/283.33)(C/V)(rU/rS),
in which Vis the volume,in mL,of Oral Solution taken to prepare the Assay preparation,and the other terms are as defined therein.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1432
Phone Number:1-301-816-8379