Halazone Tablets for Solution
» Halazone Tablets for Solution contain not less than 90.0 percent and not more than 135.0 percent of the labeled amount of C7H5Cl2NO4S.
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.
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.
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Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
Senior Scientific Liaison
1-301-816-8161
(SM12010) Monographs - Small Molecules 1
701 Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison
1-301-816-8106
(GCDF2010) General Chapters - Dosage Forms
USP35–NF30 Page 3394