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Saccharin Sodium
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C7H4NNaO3S·2H2O 241.20

1,2-Benzisothiazol-3(2H)-one, 1,1-dioxide, sodium salt, dihydrate.
1,2-Benzisothiazolin-3-one 1,1-dioxide sodium salt dihydrate [6155-57-3].

Anhydrous 205.17 [128-44-9].
» Saccharin Sodium contains not less than 98.0 percent and not more than 101.0 percent of C7H4NNaO3S, calculated on the anhydrous basis.
Packaging and storage— Preserve in well-closed containers.
Labeling— Where the quantity of saccharin sodium is indicated in the labeling of any preparation containing Saccharin Sodium, this shall be expressed in terms of saccharin (C7H5NO3S).
Identification—
A: The residue obtained by igniting it responds to the tests for Sodium 191.
B: To 10 mL of a solution (1 in 10) add 1 mL of hydrochloric acid: a crystalline precipitate of saccharin is formed. Wash the precipitate with cold water until the last washing is free from chloride, and dry at 105 for 2 hours: it melts between 226 and 230, the procedure for Class I being used (see Melting Range or Temperature 741).
Alkalinity— A solution (1 in 10) is neutral or alkaline to litmus, but no red color is produced with phenolphthalein TS.
Toluenesulfonamides—
Internal standard solution, Standard stock solution, and Standard preparations—Prepare as directed for Internal standard solution, Standard stock solution, and Standard preparations in the test for Toluenesulfonamides under Saccharin (see NF monograph).
Test preparation— Prepare as directed under Column Partition Chromatography (see Chromatography 621), employing a chromatographic tube fitted with a porous glass disk in its base, a plastic stopcock on the delivery tube, and a reservoir on the top. Add a mixture consisting of 10 g of Solid Support and a solution of 2.0 g, accurately weighed, of Saccharin Sodium in 8.0 mL of sodium carbonate solution (1 in 20), and proceed as directed under Test preparation in the test for Toluenesulfonamides under Saccharin (see NF monograph), beginning with “Pack the contents.”
Chromatographic system and Procedure—Proceed as directed for Chromatographic system and Procedure in the test for Toluenesulfonamides under Saccharin (see NF monograph).
Heavy metals, Method I 231— Dissolve 4 g in 46 mL of water, add 4 mL of 1 N hydrochloric acid, mix, and rub the inner wall of the vessel with a glass rod until crystallization begins. Allow the solution to stand for 1 hour, and then filter through a dry filter, discarding the first 10 mL of the filtrate: the limit, determined on 25 mL of the subsequent filtrate, is 0.001%.
Organic volatile impurities, Method IV 467: meets the requirements.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It responds to Identification tests A and B, and meets the requirements of the tests for Water, Benzoate and salicylate, Selenium, and Readily carbonizable substances under Saccharin Calcium.
Assay— Proceed with Saccharin Sodium as directed in the Assay under Saccharin Calcium. Each mL of 0.1 N sodium hydroxide is equivalent to 20.52 mg of C7H4NNaO3S.
Auxiliary Information— Staff Liaison : Catherine Sheehan, B.Sc., Scientist
Expert Committee : (EM105) Excipient Monographs 1
USP29–NF24 Page 1938
Pharmacopeial Forum : Volume No. 31(4) Page 1225
Phone Number : 1-301-816-8262