ASTM D565

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. Scope

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 the standard.

1.2.1 The dimensions for the color comparator (see 5.3 and Fig. 1) are excepted for that part of the apparatus.

1.3This 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 and health practices and determine the applicability of regulatory limitations prior to use. For specific hazard statements, see 2.

2. Referenced Documents

D1193 Specification for Reagent Water

21CFR 172.878 Food and Drug Administration Title
Monograph on Light Mineral Oil
Monograph on Mineral Oil
National Formulary-Current Edition
United States Pharmacopeia-Current Edition

Index Terms

carbonizable substances; mineral oil; ICS Number Code 75.080; 75.080

Citing ASTM Standards

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