Sodium Thiosulfate Injection
» Sodium Thiosulfate Injection is a sterile solution of Sodium Thiosulfate in freshly boiled Water for Injection. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of Na2S2O3·5H2O.
Packaging and storage— Preserve in single-dose containers, of Type I glass.
Identification— It responds to the Identification tests under Sodium Thiosulfate.
Bacterial endotoxins 85 It contains not more than 0.03 USP Endotoxin Unit per mg of sodium thiosulfate.
pH 791: between 6.0 and 9.5.
Other requirements— It meets the requirements under Injections 1.
Assay— Transfer to a suitable container an accurately measured volume of Injection, containing about 1 g of sodium thiosulfate, and adjust by the addition of 3 N hydrochloric acid to a pH of between 6.2 and 6.7. Dilute with water to about 20 mL, and titrate with 0.1 N iodine VS, adding 3 mL of starch TS as the endpoint is approached. Each mL of 0.1 N iodine is equivalent to 24.82 mg of Na2S2O3·5H2O.
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Topic/Question Contact Expert Committee
Monograph Elena Gonikberg, Ph.D.
Senior Scientist
1-301-816-8251
(MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3586