ASTM D5227-21

Standard Test Method for Measurement of Hexane Extractable Content of Polyolefins

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.
SCOPE
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.

General Information

• Status: Published
• Publication Date: 30-Jun-2021
• ICS: 83.080.20 - Thermoplastic materials
• Technical Committee: D20 - Plastics
• Drafting Committee: D20.70 - Analytical Methods

Standards Content (Sample)

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.
Designation:D5227 −21
Standard Test Method for
1
Measurement of Hexane Extractable Content of Polyolefins
This standard is issued under the fixed designation D5227; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope* D1239 Test Method for Resistance of Plastic Films to
Extraction by Chemicals
1.1 This test method describes an extraction/gravimetric
D1600 Terminology forAbbreviatedTerms Relating to Plas-
procedure for determination of the amount of hexane soluble
tics
low molecular weight material present in polyethylene,
E131 Terminology Relating to Molecular Spectroscopy
polypropylene, ethylene-propylene copolymers, and ethylene-
E456 Terminology Relating to Quality and Statistics
vinyl acetate copolymers. This test method is a modification of
E691 Practice for Conducting an Interlaboratory Study to
the Food and Drug Administration (FDA) procedure for
Determine the Precision of a Test Method
determining hexane extractables of polyolefins. This test
E2935 Practice for Evaluating Equivalence of Two Testing
method is based upon the presumption that the weight of the
Processes
residue extract present in the solvent is equal to the amount
3
2.2 Federal Document:
extracted from the film sample and could therefore be quanti-
21 CFR 177.1520 Olefin Polymers
fied by measuring the weight loss of the extracted film,
eliminating the complex and time-consuming evaporation
3. Terminology
process described in 21 CFR 177.1520.
3.1 The definitions given in Terminology D883, D1600,
1.2 This standard does not purport to address all of the
E131, and E456 are applicable to this test method.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
3.2 Abbreviations:
priate safety, health, and environmental practices and deter-
3.2.1 EVA—ethylene-vinyl acetate copolymer.
mine the applicability of regulatory limitations prior to use.
3.2.2 LDPE—low-density polyethylene.
1.3 The values stated in SI units are to be regarded as the
3.2.3 HDPE—high-density polyethylene.
standard. Units used in 21 CFR 177.1520 are also used in this
3.2.4 LLDPE—linear low-density polyethylene.
test method. Units are in conformance with Federal Code 21
CFR 177.1520, from which this test method is derived.
3.2.5 FDA—Food and Drug Administration.
NOTE 1—There is no known ISO equivalent to this standard. 3.2.6 PP—polypropylene.
1.4 This international standard was developed in accor-
4. Summary of Test Method
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the
4.1 Film samples are extracted with hexane for 2 h at 49.5
Development of International Standards, Guides and Recom-
6 0.5°C, dried, and weighed.
mendations issued by the World Trade Organization Technical
4.2 The loss in weight of the film is presumed to be equal to
Barriers to Trade (TBT) Committee.
the extractable content determined by solvent evaporation in
the FDA protocol.
2. Referenced Documents
2
2.1 ASTM Standards:
5. Significance and Use
D883 Terminology Relating to Plastics
5.1 FDArequirements for maximum extractables are speci-
fied for resin and uses. This test method provides a means to
1 determine the amount of hexane-soluble low molecular weight
This test method is under the jurisdiction ofASTM Committee D20 on Plastics
and is the direct responsibility of Subcommittee D20.70 on Analytical Methods. material present in polyolefins. It is applicable to resins
Current edition approved July 1, 2021. Published July 2021. Originally approved
containing greater than 0.20 % extractables.
in 1992. Last previous edition approved in 2013 as D5227 - 13. DOI: 10.1520/
D5227-21.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
3
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Available from Standardization Documents Order Desk, DODSSP, Bldg. 4,
Standards volume information, refer to the standard’s Document Summary page on Section D, 700 Robbins Ave., Philadelphia, PA 19111-5098, http://
the ASTM website. www.dodssp.daps.mil.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
D5227−21
9.3 Stopperthekettleandclamptheassemblyintothewater
bath set at 49.5 6 0.5°C.
NOTE 2—Tempe
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: D5227 − 13 D5227 − 21
Standard Test Method for
1
Measurement of Hexane Extractable Content of Polyolefins
This standard is issued under the fixed designation D5227; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope*
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 safety, health, and healthenvironmental 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
2
2.1 ASTM Standards:
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
3
2.2 Federal Document:
21 CFR 177.1520 CFR 177.1520Olefin Polymers
1
This test method is under the jurisdiction of ASTM Committee D20 on Plastics and is the direct responsibility of Subcommittee D20.70 on Analytical Methods.
Current edition approved June 1, 2013July 1, 2021. Published July 2013July 2021. Originally approved in 1992. Last previous edition approved in 20082013 as
ε1
D5227 - 01D5227 - 13.(2008) . DOI: 10.1520/D5227-13.10.1520/D5227-21.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Available from Standardization Documents Order Desk, DODSSP, Bldg. 4, Section D, 700 Robbins Ave., Philadelphia, PA 19111-5098, http://www.dodssp.daps.mil.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
D5227 − 21
3. Terminology
3.1 The definitions given in Terminology D883, D1600, E131and, E131and E456 are applicable to this test method.
3.2 Abbreviations:
3.2.1 EVA—ethylene-vinyl acetate copolymer.
3.2.2 LDPE—low-density polyethylene.
3.2.3 HDPE—high-density polyethylene.
3.2.4 LLDPE—linear low-density polyethylene.
3.2.5 FDA—Food and Drug Administration.
3.2.6 PP—polypropylene.
4. Summary of Test Method
4.1 Film samples are extracted with hexane for 2 h at 49.5 6 0.5°C, dried, and weighed.
4.2 The loss in weight of the film is presumed to be equal to the extractable content determined by solvent evaporation in the FDA
protocol.
5. 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-solubl
...