(proe' pil gal' ate).
Propyl Gallate contains NLT 98.0% and NMT 102.0% of propyl gallate (C10H12O5), calculated on the dried basis.
• B. Ultraviolet Absorption 197U
Sample solution: 10 µg/mL in methanol
Acceptance criteria: Meets the requirements
Standard solution: 10 µg/mL of USP Propyl Gallate RS in methanol
Sample solution: 10 µg/mL of Propyl Gallate in methanol
Analytical wavelength: Maximum at about 273 nm
Cell: 1 cm
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
Acceptance criteria: 98.0%102.0% on the dried basis
• Residue on Ignition 281: NMT 0.1%
• Heavy Metals, Method II 231: NMT 10 ppm
• Melting Range or Temperature 741: 146150
• Loss on Drying 731: Dry a sample at 105 for 4 h: it loses NMT 0.5% of its weight.
• Packaging and Storage: Preserve in tight containers, protected from light, and avoid contact with metals.
• USP Reference Standards 11
USP Propyl Gallate RS
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USP35NF30 Page 1931