Aminohippurate Sodium 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)
C9H9N2NaO3 216.17
Glycine, N-(4-aminobenzoyl)-, monosodium salt;
Monosodium p-aminohippurate CAS RN®: 94-16-6; UNII: SUO3KVS109.
1 DEFINITION
Aminohippurate Sodium Injection is a sterile solution of Aminohippuric Acid in Water for Injection prepared with the aid of Sodium Hydroxide. It contains NLT 95.0% and NMT 105.0% of the labeled amount of aminohippurate sodium (C9H9N2NaO3 ).
2 IDENTIFICATION
A.
Sample solution: A volume of Injection equivalent to 100 mg of aminohippuric acid
Analysis: Dilute the Sample solution with water to 50 mL. To 5 mL of this solution add 0.5 mL of 3 N hydrochloric acid, 0.5 mL of sodium nitrite solution (1 in 10), and a solution of 0.20 g of 2-naphthol in 10 mL of 6 N ammonium hydroxide.
Acceptance criteria: A red color is produced.
B.
Sample solution: A volume of Injection equivalent to about 200 mg of aminohippurate sodium
Analysis: In the order named, add to the Sample solution 2 mL of potassium iodide TS, 10 mL of water, and 5 mL of sodium hypochlorite TS.
Acceptance criteria: A red color is produced.
C. A sample imparts an intense yellow color to a nonluminous flame.
3 ASSAY
PROCEDURE
Sample solution: A volume of Injection equivalent to 1 g of aminohippurate sodium
Analysis: Transfer the Sample solution to a 200-mL volumetric flask, and dilute with water to volume. Transfer 50.0 mL of the solution to a suitable container, and add 5 mL of hydrochloric acid. Proceed as directed in Nitrite Titration (451), beginning with "cool to about 15°". Each mL of 0.1 M sodium nitrite is equivalent to 21.62 mg of aminohippurate sodium (C9H9N2NaO3 ).
Acceptance criteria: 95.0%-105.0%
4 SPECIFIC TESTS
pH (791): 6.7-7.6
BACTERIAL ENDOTOXINS TEST (85): NMT 0.04 USP Endotoxin Units/mg of aminohippurate sodium
OTHER REQUIREMENTS: Meets the requirements in Injections and Implanted Drug Products (1).
5 ADDITIONAL REQUIREMENTS
PACKAGING AND STORAGE: Preserve in single-dose or multiple-dose containers, preferably of Type I glass.
