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Significance and Use
4.1 This test method is a means for ascertaining whether pharmaceutical mineral oil conforms to the standards of the United States Pharmacopeia, the National Formulary, and the Food and Drug Administration.
1.1 This test method covers white mineral oil (Mineral Oil USP and Light Mineral Oil NF) to determine whether it conforms to the standard of quality required for pharmaceutical use as defined by the United States Pharmacopeia and the National Formulary, or the Food and Drug Administration.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.2.1 Exception—Dimension requirements for the color comparator in are in SI and inch-pound units.
FIG. 1 Color Comparator for Carbonizable Substances in Liquid Petrolatum
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. For specific hazard statements, see Section .
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D1193 Specification for Reagent Water
Official CompendiaMonograph on Light Mineral Oil Monograph on Mineral Oil National Formulary—Current Edition United States Pharmacopeia—Current Edition
Government Document21CFR 172.878 Food and Drug Administration Title
ICS Number Code 75.100 (Lubricants, industrial oils and related products)
UNSPSC Code 15120000(Lubricants and oils and greases and anti corrosives)
|Link to Active (This link will always route to the current Active version of the standard.)|
ASTM D565-99(2019), Standard Test Method for Carbonizable Substances in White Mineral Oil, ASTM International, West Conshohocken, PA, 2019, www.astm.orgBack to Top