Packaging and storage— Preserve in single-dose containers, of Type I glass.

USP Reference standards 11— USP Endotoxin RS.

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.

Residual solvents 467: meets the requirements.

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.

Expert Committee : (MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine

USP29–NF24 Page 1993

Phone Number : 1-301-816-8251