Saccharin Sodium
;)
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 98.0percent and not more than 101.0percent 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 á191ñ.
B:
To 10mLof a solution (1in 10)add 1mLof 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 2hours:it melts between 226and 230,the procedure for Class Ibeing used (see Melting Range or Temperature á741ñ).
for 2hours:it melts between 226and 230,the procedure for Class Ibeing used (see Melting Range or Temperature á741ñ).
Alkalinity—
Asolution (1in 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 preparationsin the test for Toluenesulfonamidesunder Saccharin(see NFmonograph).
Test preparation—
Prepare as directed under Column Partition Chromatography(see Chromatography á621ñ),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 10g of Solid Supportand a solution of 2.0g,accurately weighed,of Saccharin Sodium in 8.0mLof sodium carbonate solution (1in 20),and proceed as directed under Test preparationin the test for Toluenesulfonamidesunder Saccharin(see NFmonograph),beginning with “Pack the contents.”
Chromatographic system
and Procedure—Proceed as directed for Chromatographic systemand Procedurein the test for Toluenesulfonamidesunder Saccharin(see NFmonograph).
Heavy metals,Method Iá231ñ—
Dissolve 4g in 46mLof water,add 4mLof 1Nhydrochloric acid,mix,and rub the inner wall of the vessel with a glass rod until crystallization begins.Allow the solution to stand for 1hour,and then filter through a dry filter,discarding the first 10mLof the filtrate:the limit,determined on 25mLof the subsequent filtrate,is 0.001%.
Organic volatile impurities,Method IVá467ñ:
meets the requirements.
Other requirements—
It responds to Identificationtests Aand B,and meets the requirements of the tests for Water,Benzoate and salicylate,Selenium,and Readily carbonizable substancesunder Saccharin Calcium.
Assay—
Proceed with Saccharin Sodium as directed in the Assayunder Saccharin Calcium.Each mLof 0.1Nsodium hydroxide is equivalent to 20.52mg of C7H4NNaO3S.
Auxiliary Information—
Staff Liaison:Justin Lane,B.S.,Scientific Associate
Expert Committee:(EMC)Excipients:Monograph Content
USP28–NF23Page 1745
Pharmacopeial Forum:Volume No.30(4)Page 1427
Phone Number:1-301-816-8323