Idoxuridine
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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)
1 DEFINITION
Idoxuridine contains NLT 98.0% and NMT 101.0% of idoxuridine (C₉H₁₁IN₂O₅), calculated on the dried basis.
2 IDENTIFICATION
Change to read:
A. ▲Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197M▲ (CN 1-May-2020)
Change to read:
B. ▲Spectroscopic Identification Tests 〈197〉, Ultraviolet-Visible Spectroscopy: 197U▲ (CN 1-May-2020)
Analytical wavelength: 279 nm
Buffer: pH 12.0 solution prepared as follows. Dissolve 7.46 g of potassium chloride and 24 mL of 1 N sodium hydroxide in 2000 mL of water.
Sample solution: 35 µg/mL in Buffer
Acceptance criteria: Absorptivities, calculated on the dried basis for the Sample solution only, do not differ by more than 2.0%.
3 ASSAY
Procedure
Sample: 250 mg
Titrimetric system
Mode: Direct titration
Titrant: 0.1 N sodium methoxide in toluene VS
Endpoint detection: Visual
Analysis:
Dissolve the Sample in 20 mL of dimethylformamide that has previously been neutralized with Titrant, and add 3 mg/mL of thymol blue in methanol as the indicator. Titrate with Titrant to a blue endpoint. Take precautions against absorption of atmospheric carbon dioxide. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N sodium methoxide is equivalent to 35.41 mg of idoxuridine (C₉H₁₁IN₂O₅).
Acceptance criteria: 98.0%–101.0% on the dried basis
4 SPECIFIC TESTS
Loss on Drying 〈731〉
Sample: 500 mg
Analysis: Dry the Sample under vacuum at 60° for 2 h.
Acceptance criteria: NMT 1.0%
5 ADDITIONAL REQUIREMENTS
Packaging and Storage: Preserve in tight, light-resistant containers.
USP Reference Standards 〈11〉
USP Idoxuridine RS
