Mineral Oil, Rectal
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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
Mineral Oil, Rectal, is Mineral oil that has been suitably packaged.
2 IDENTIFICATION
Change to read:
A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197F
B. It meets the requirements in Specific Tests for Viscosity-Capillary Methods 〈911〉.
3 SPECIFIC TESTS
3.1 Specific Gravity 〈841〉
0.845–0.905
3.2 Viscosity-Capillary Methods 〈911〉
34.5–150.0 mm²·s⁻¹ for kinematic viscosity, measured with a capillary viscometer at 40 ± 0.1°
3.3 Acidity
Sample: 10 mL
Analysis: Add 20 mL of boiling water to the Sample, and shake vigorously for about 1 min. Allow to cool, and draw off the separated water. To 10 mL of the filtered aqueous layer add 0.1 mL of phenolphthalein TS.
Acceptance criteria: The solution does not produce a pink color. NMT 1.0 mL of 0.01 N sodium hydroxide is required to produce a pink color.
4 ADDITIONAL REQUIREMENTS
Packaging and Storage: Preserve in tight, light-resistant, single-unit containers. No storage requirements specified.
USP Reference Standards 〈11〉
USP Mineral Oil RS
