Propyl Gallate
C10H12O5 212.20
Benzoic acid, 3,4,5-trihydroxy-, propyl ester;
Propyl gallate
[121-79-9].
(proe' pil gal' ate).
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C10H12O5 212.20
Benzoic acid, 3,4,5-trihydroxy-, propyl ester;
Propyl gallate
[121-79-9].DEFINITION
Propyl Gallate contains NLT 98.0% and NMT 102.0% of propyl gallate (C10H12O5), calculated on the dried basis.
IDENTIFICATION
• B. Ultraviolet Absorption 
197U
197U
Sample solution:
10 µg/mL in methanol
Acceptance criteria:
Meets the requirements
ASSAY
• 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
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
IMPURITIES
• Residue on Ignition 281:
NMT 0.1%
281:
NMT 0.1%
• Heavy Metals, Method II 231:
NMT 10 ppm
231:
NMT 10 ppm
SPECIFIC TESTS
• Melting Range or Temperature 741:
146
–150
741:
146–150
• Loss on Drying 731:
Dry a sample at 105 for 4 h: it loses NMT 0.5% of its weight.
731:
Dry a sample at 105 for 4 h: it loses NMT 0.5% of its weight.
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight containers, protected from light, and avoid contact with metals.
• USP Reference Standards 11
11
USP Propyl Gallate RS
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Robert H. Lafaver, M.S.
Scientific Liaison 1-301-816-8335 |
(EXC2010) Monographs - Excipients |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 1931