ASTM_D_565_-_99_2019.pdf

Designation:D56599(Reapproved 2019)Standard Test Method forCarbonizable Substances in White Mineral Oil1This standard is issued under the fixed designation D565;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.This standard has been approved for use by agencies of the U.S.Department of Defense.1.Scope1.1 This test method covers white mineral oil(Mineral OilUSP and Light Mineral Oil NF)to determine whether itconforms to the standard of quality required for pharmaceuticaluse as defined by the United States Pharmacopeia and theNational Formulary,or the Food and Drug Administration.1.2 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.2.1 ExceptionDimension requirements for the colorcomparator in Fig.1 are in SI and inch-pound units.1.3 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety,health,and environmental practices and deter-mine the applicability of regulatory limitations prior to use.For specific hazard statements,see Section 6.1.4 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade(TBT)Committee.2.Referenced Documents2.1 ASTM Standards:2D1193 Specification for Reagent Water2.2 Offcial Compendia:3United States PharmacopeiaCurrent EditionMonograph on Mineral OilNational FormularyCurrent EditionMonograph on Light Mineral Oil2.3 Government Document:421CFR 172.878 Food and Drug Administration Title3.Summary of Test Method3.1 The mineral oil is treated with concentrated sulfuric acid(H2SO4)under prescribed conditions and the resulting color iscompared with a reference standard to determine whether itpasses or fails the test.4.Significance and Use4.1 This test method is a means for ascertaining whetherpharmaceutical mineral oil conforms to the standards of theUnited States Pharmacopeia,the National Formulary,and theFood and Drug Administration.5.Apparatus5.1 Test Tube,as shown in Fig.1,of heat-resistant glassfitted with a well-ground glass stopper,the stopper and the tubebearing identical and indestructible numbers.The tube shall be140 mm 6 2 mm in length and between 14.5 mm and15.0 mm in outside diameter,and shall be calibrated at the5 mL 6 0.2 mL and 10 mL 6 0.2 mL liquid levels.Thecapacity of the tube with stopper inserted shall be between13.6 mL and 15.6 mL.A rolled edge can be provided forsuspending the tube on the cover of the water bath.5.2 Water Bath,suitable for immersing the test tube abovethe 10 mLline equipped to maintain a temperature of 100 C 60.5 C.The bath shall be provided with a cover of any suitablematerial with holes approximately 16 mm in diameter throughwhich the test tubes can be suspended.5.3 Color Comparator,of a suitable type for observing thecolor of the acid layer in comparison with the referencestandard color solution.The size and shape of the comparatorare optional,but the size and shape of the apertures shallconform to the dimensions prescribed in Fig.1.1This test method is under the jurisdiction of ASTM Committee D02 onPetroleum Products,Liquid Fuels,and Lubricantsand is the direct responsibility ofSubcommittee D02.06 on Analysis of Liquid Fuels and Lubricants.Current edition approved Jan.1,2019.Published January 2019.Originallyapproved in 1940.Last previous edition approved in 2013 as D565 99(2013).DOI:10.1520/D0565-99R19.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Available from U.S.Pharmacopeial Convention,12601 Twinbrook Parkway,Rockville,MD 20852.4Available from Standardization Documents Order Desk,DODSSP,Bldg.4,Section D,700 Robbins Ave.,Philadelphia,PA 19111-5098.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade(TBT)Committee.1 6.Reagents6.1 Purity of ReagentsReagent grade chemicals shall beused in all tests.Unless otherwise indicated,it is intended thatall reagents shall conform to the specifications of the Commit-tee on Analytical Reagents of th