Packaging and storage— Preserve in tight,light-resistant containers.

Labeling— Label the Halazone Tablets for Solution to indicate that they are not intended to be swallowed.

Identification— Finely powder a number of Halazone Tablets for Solution,equivalent to about 150mg of halazone:a portion of the powder,equivalent to about 100mg of halazone,responds to the Identificationtest under Halazone.

Disintegration á701ñ: 10minutes.

Uniformity of dosage units á905ñ: meet the requirements,except that if the average value of the dosage units tested is between 100.0percent and 135.0percent,Criterion(B)(3)applies.

pHá791ñ: not less than 7.0,in a solution of 1Halazone Tablet for Solution,containing 4mg of halazone,in 200mLof water.

Assay— Transfer a counted number of Halazone Tablets for Solution,equivalent to about 160mg of halazone,to a suitable container,and proceed as directed in the Assayunder Halazone.Each mLof 0.1Nsodium thiosulfate is equivalent to 6.752mg of C7H5Cl2NO4S.

Expert Committee:(GTB)General Toxicology and Biocompatibility

USP28–NF23Page 935

Phone Number:1-301-816-8339