Papain Tablets for Topical Solution
» Papain Tablets for Topical Solution contain not less than 100.0 percent of the labeled potency.
Packaging and storage Preserve in tight, light-resistant containers in a cool place.
Completeness of solution 641 Prepare a solution of 50 Tablets in 500.0 mL of water, allow to stand for 4 hours, filter through 2 superimposed, 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 6 to 18 hours, 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 50 mg (1 mg per Tablet).
Microbial enumeration tests 61 and Tests for specified microorganisms 62 It meets the requirements of the tests for absence of Staphylococcus aureus and Pseudomonas aeruginosa.
Disintegration 701: not more than 15 minutes at 23 ± 2.
pH 791: between 6.9 and 8.0, determined in a solution of 1 Tablet in 10 mL.
Dibasic sodium phosphate , 0.05 M; Citric acid, 0.05 M; Casein substrate; Buffer solution; Trichloroacetic acid solution; and Standard preparationPrepare as directed in the Assay under Papain.
Assay preparation Place a counted number of Papain Tablets for Topical Solution, equivalent to about 600,000 USP Units of Papain, in a 100-mL volumetric flask, dissolve in Buffer solution, dilute with Buffer solution to volume, and mix. Transfer 2.0 mL of this solution to a 50-mL volumetric flask, dilute with Buffer solution to volume, and mix.
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USP32NF27 Page 3205