Papain Tablets for Topical Solution
»Papain Tablets for Topical Solution contain not less than 100.0percent of the labeled potency.
Packaging and storage— Preserve in tight,light-resistant containers in a cool place.
Completeness of solution á641ñ— Prepare a solution of 50Tablets in 500.0mLof water,allow to stand for 4hours,filter through 2superimposed,matched-weight,47-mm diameter,0.8-µm porosity membrane filters,and wash the residue by rinsing the flask at the sides of the holder with water.Dry both filters in a desiccator under vacuum,over phosphorus pentoxide,for 6to 18hours,weigh the filters separately,and subtract the weight of the lower filter from that of the upper filter:the difference in the weights is not more than 50mg (1mg per Tablet).
Microbial limits á61ñ— It meets the requirements of the tests for absence of Staphylococcus aureusand Pseudomonas aeruginosa.
Disintegration á701ñ: not more than 15minutes at 23±2.
pHá791ñ: between 6.9and 8.0,determined in a solution of 1Tablet in 10mL.
Assay—
Dibasic sodium phosphate ,0.05M;Citric acid,0.05M;Casein substrate;Buffer solution;Trichloroacetic acid solution;and Standard preparation—Prepare as directed in the Assayunder Papain.
Assay preparation— Place a counted number of Papain Tablets for Topical Solution,equivalent to about 600,000USP Units of Papain,in a 100-mLvolumetric flask,dissolve in Buffer solution,dilute with Buffer solutionto volume,and mix.Transfer 2.0mLof this solution to a 50-mLvolumetric flask,dilute with Buffer solutionto volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Papain.By interpolation from the standard curve,calculate the potency,in Units,in the number of Tablets taken by the formula:
(50,000/3)CA,
in which the factors are as defined therein.
Auxiliary Information— Staff Liaison:Larry N.Callahan,Ph.D.,Scientist
Expert Committee:(BNT)Biotechnology and Natural Therapeutics/Diagnostics
USP28–NF23Page 1465
Phone Number:1-301-816-8385