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Significance and Use
5.1 FDA requirements for maximum extractables are specified for resin and uses. This test method provides a means to determine the amount of hexane-soluble low molecular weight material present in polyolefins. It is applicable to resins containing greater than 0.20 % extractables.
1.1 This test method describes an extraction/gravimetric procedure for determination of the amount of hexane soluble low molecular weight material present in polyethylene, polypropylene, ethylene-propylene copolymers, and ethylene-vinyl acetate copolymers. This test method is a modification of the Food and Drug Administration (FDA) procedure for determining hexane extractables of polyolefins. This test method is based upon the presumption that the weight of the residue extract present in the solvent is equal to the amount extracted from the film sample and could therefore be quantified by measuring the weight loss of the extracted film, eliminating the complex and time-consuming evaporation process described in 21 CFR 177.1520.
1.2 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.
1.3 The values stated in SI units are to be regarded as the standard. Units used in 21 CFR 177.1520 are also used in this test method. Units are in conformance with Federal Code 21 CFR 177.1520, from which this test method is derived.
Note 1: There is no known ISO equivalent to this standard.
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.
D883 Terminology Relating to Plastics
D1239 Test Method for Resistance of Plastic Films to Extraction by Chemicals
D1600 Terminology for Abbreviated Terms Relating to Plastics
E131 Terminology Relating to Molecular Spectroscopy
E456 Terminology Relating to Quality and Statistics
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
E2935 Practice for Evaluating Equivalence of Two Testing Processes
ICS Number Code 83.080.20 (Thermoplastic materials)
UNSPSC Code 13111016(Polyethylene)
|Link to Active (This link will always route to the current Active version of the standard.)|
ASTM D5227-21, Standard Test Method for Measurement of Hexane Extractable Content of Polyolefins, ASTM International, West Conshohocken, PA, 2021, www.astm.orgBack to Top