1.1
This test method covers determination of carbonizable substances in paraffin wax. The test method is applicable to paraffin wax for pharmaceutical use, as defined by the U.S. National Formulary, with a melting point as determined in accordance with Test Method
D87
, between 117 °F and 149 °F (47 °C and 65 °C).
1.2
The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.
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 and health practices and determine the applicability of regulatory limitations prior to use.
Specific warning statements are given in
Annex A1
.
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.
====== Significance And Use ======
4.1
This test method is a means for ascertaining whether pharmaceutical paraffin wax conforms to the standards for quality prescribed by the U.S. National Formulary.