Sodium Thiosulfate Injection
»Sodium Thiosulfate Injection is a sterile solution of Sodium Thiosulfate in freshly boiled Water for Injection.It contains not less than 95.0percent and not more than 105.0percent of the labeled amount of Na2S2O3·5H2O.
Packaging and storage— Preserve in single-dose containers,of Type Iglass.
Identification— It responds to the Identificationtests under Sodium Thiosulfate.
Bacterial endotoxins á85ñ— It contains not more than 0.03USP Endotoxin Unit per mg of sodium thiosulfate.
pHá791ñ: between 6.0and 9.5.
Other requirements— It meets the requirements under Injections á1ñ.
Assay— Transfer to a suitable container an accurately measured volume of Injection,containing about 1g of sodium thiosulfate,and adjust by the addition of 3Nhydrochloric acid to a pHof between 6.2and 6.7.Dilute with water to about 20mL,and titrate with 0.1Niodine VS,adding 3mLof starch TSas the endpoint is approached.Each mLof 0.1Niodine is equivalent to 24.82mg of Na2S2O3·5H2O.
Auxiliary Information— Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 1795
Phone Number:1-301-816-8251