Zinc Acetate Oral Solution
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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
Zinc Acetate Oral Solution contains NLT 90.0% and NMT 110.0% of the labeled amount of zinc (Zn) as zinc acetate dihydrate (C4H6O4Zn· 2H2O). It may contain one or more suitable flavors and sweeteners, which are recognized as safe, in amounts that are unobjectionable.
2 IDENTIFICATION
A. Identification Tests—General, Zinc 〈191〉and Acetate 〈191〉: Meets the requirements
3 ASSAY
Procedure
Sample: An accurately measured volume of Oral Solution, equivalent to 40 mg of zinc
Blank: 100 mL of water, 5 mL of ammonia–ammonium chloride buffer TS, and 0.1 mL of eriochrome black TS
Titrimetric system (See Titrimetry 〈541〉.)
Mode: Direct titration
Titrant: 0.05 M edetate disodium VS
Endpoint detection: Visual
Analysis: Transfer the Sample to a 250-mL ask. Add 100 mL of water, 5 mL of ammonia–ammonium chloride buffer TS, and 0.1 mL of eriochrome black TS. Titrate with Titrant to a green endpoint.
Calculate the percentage of the labeled amount of zinc (Zn) in the portion of Oral Solution taken:
Result = {[(VS − VB ) × M × F]/W} × 100
VS = Titrant volume consumed by the Sample (mL)
VB = Titrant volume consumed by the Blank (mL)
M = actual molarity of the Titrant (mmol/mL)
F = equivalency factor, 65.4 mg/mmol
W = nominal amount of zinc in the Sample (mg)
Acceptance criteria: 90.0%–110.0%
4 SPECIFIC TESTS
pH 〈791〉: 5.7–6.3
Microbial Enumeration Tests 〈61〉and Tests for Specified Microorganisms 〈62〉: The total aerobic microbial count does not exceed 102 cfu/mL. The total molds and yeasts count does not exceed 101 cfu/mL. It meets the requirement of the test for absence of Escherichia coli.
5 ADDITIONAL REQUIREMENTS
Packaging and Storage: Preserve in well-closed containers, and store in a cool, dry place protected from light.
Labeling: Label the Oral Solution in terms of zinc acetate dihydrate (C4H6O4Zn· 2H2O) and in terms of elemental zinc.
