Sodium Thiosulfate Injection
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
To view the Notice from the Expert Committee that posted in conjunction with this accelerated revision, please click www.uspnf.com/rb-sodium-thiosulfate-inj-20230331.
1 DEFINITION
Sodium Thiosulfate Injection is a sterile solution of Sodium Thiosulfate in freshly boiled Water for Injection. It contains NLT 95.0% and NMT 105.0% of the labeled amount of sodium thiosulfate (Na2S2O3 · 5H2O).
2 IDENTIFICATION
A. Sample solution: Equivalent to 0.1 g/mL of sodium thiosulfate in water
Analysis: Add a few drops of iodine TS.
Acceptance criteria: The color is discharged.
B. Identification Tests—General 〈191〉, Sodium
Sample solution: Equivalent to 0.1 g/mL of sodium thiosulfate in water
Acceptance criteria: Meets the requirements
C. Identification Tests—General 〈191〉, Thiosulfate
Sample solution: Equivalent to 0.1 g/mL of sodium thiosulfate in water
Acceptance criteria: Meets the requirements
3 ASSAY
Procedure
Sample solution: Equivalent to 1 g of sodium thiosulfate from Injection. Adjust with a suitable solution of dilute hydrochloric acid or dilute sodium hydroxide to a pH of 6.2–6.7, and dilute with water to about 20 mL.
Titrimetric system
(See Titrimetry 〈541〉.)
Mode: Direct titration
Titrant: 0.1 N iodine VS
Endpoint detection: Visual
Analysis: Titrate the Sample solution with Titrant, adding 3 mL of starch TS as the endpoint is approached. Each mL of Titrant is equivalent to 24.82 mg of sodium thiosulfate (Na2S2O3 · 5H2O).
Acceptance criteria: 95.0%–105.0%
4 SPECIFIC TESTS
Bacterial Endotoxins Test 〈85〉: NMT 0.03 USP Endotoxin Units/mg of sodium thiosulfate
pH 〈791〉: 6.0–9.5
Other Requirements: Meets the requirements in Injections and Implanted Drug Products 〈1〉
5 ADDITIONAL REQUIREMENTS
Change to read:
Packaging and Storage: Preserve in single-dose containers, preferably (RB 1-Apr-2023) of Type I glass.
