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 150 mg of halazone: a portion of the powder, equivalent to about 100 mg of halazone, responds to the Identification test under Halazone.

Disintegration 701: 10 minutes.

Uniformity of dosage units 905: meet the requirements, except that if the average value of the dosage units tested is between 100.0 percent and 135.0 percent, Criterion (B) (3) applies.

pH 791: not less than 7.0, in a solution of 1 Halazone Tablet for Solution, containing 4 mg of halazone, in 200 mL of water.

Residual solvents 467: meet the requirements.

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

Expert Committee : (GTMDB05) General Toxicology and Medical Device Biocompatibility

USP29–NF24 Page 1040

Phone Number : 1-301-816-8339