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 limits 61—
It meets the requirements of the tests for absence of
Staphylococcus aureus and
Pseudomonas aeruginosa.
pH 791:
between 6.9 and 8.0, determined in a solution of 1 Tablet in 10 mL.
Assay—
Dibasic sodium phosphate
,
0.05 M; Citric acid,
0.05 M; Casein substrate; Buffer solution; Trichloroacetic acid solution; and
Standard preparation—Prepare 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.
Procedure—
Proceed as directed for
Procedure in the
Assay under
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.
.