Propyl Gallate
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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)
C₁₀H₁₂O₅ 212.20
Benzoic acid, 3,4,5-trihydroxy-, propyl ester;
Propyl gallate CAS RN®: 121-79-9.
1 DEFINITION
Propyl Gallate contains NLT 98.0% and NMT 102.0% of propyl gallate (C₁₀H₁₂O₅), calculated on the dried basis.
2 IDENTIFICATION
Change to read:
A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197M
Change to read:
B. Spectroscopic Identification Tests 〈197〉, Ultraviolet-Visible Spectroscopy: 197U
Sample solution: 10 µg/mL in methanol
Acceptance criteria: Meets the requirements
3 ASSAY
3.1 Procedure
Standard solution: 10 µg/mL of USP Propyl Gallate RS in methanol
Sample solution: 10 µg/mL of Propyl Gallate in methanol
Blank: Methanol
Instrumental conditions
- (See Ultraviolet-Visible Spectroscopy 〈857〉.)
- Mode: UV
- Analytical wavelength: Maximum at about 273 nm
- Cell: 1 cm
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of propyl gallate (C₁₀H₁₂O₅) in the portion of the sample taken:
Result = (Aᵤ/Aₛ) × (Cₛ/Cᵤ) × 100
Aᵤ = absorbance of the Sample solution
Aₛ = absorbance of the Standard solution
Cₛ = concentration of USP Propyl Gallate RS in the Standard solution (µg/mL)
Cᵤ = concentration of the Sample solution (µg/mL)
Acceptance criteria: 98.0%–102.0% on the dried basis
4 IMPURITIES
Residue on Ignition 〈281〉: NMT 0.1%
5 SPECIFIC TESTS
Melting Range or Temperature 〈741〉: 146°–150°
Loss on Drying 〈731〉: Dry a sample at 105° for 4 h: it loses NMT 0.5% of its weight.
6 ADDITIONAL REQUIREMENTS
Packaging and Storage: Preserve in tight containers, protected from light, and avoid contact with metals.
USP Reference Standards 〈11〉
USP Propyl Gallate RS
