ASTM F2579-18
(Specification)Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
ABSTRACT
This specification covers amorphous poly(lactide) and poly(lactide-co-glycolide) resins used in the manufacture of surgical implants. Materials covered by this specification are virgin poly(lactide) and poly(lactide-co-glycolide) resins that can be fully solvated at room temperature by methylene chloride (dichloromethane) or chloroform (trichloromethane). The poly(d,l-lactide) homopolymers are amorphous and shall be composed of meso-lactide or equimolar (racemic) combinations of d-lactide and l-lactide. The poly(d,l-lactide-co-glycolide) copolymers are amorphous and shall be composed of a combination of glycolide and either meso-lactide or a racemic combination of d-lactide and l-lactide. The resins shall be manufactured in pellet, granular, powder, flake, or other form and shall conform to the chemical and physical property requirements specified. Tests for chemical identification (by infrared, proton nuclear magnetic resonance, and carbon-13 nuclear magnetic resonance spectroscopy), specific rotation, molar mass, and residual monomer, residual solvent, and heavy metal content shall be performed and shall conform to the requirements specified. Additional tests for residual catalyst and residual water content may be performed as well.
SCOPE
1.1 This specification covers virgin amorphous poly(lactide) homopolymer and poly(lactide-co-glycolide) copolymer resins intended for use in surgical implants. The poly(dl-lactide) homopolymers covered by this specification are considered to be amorphous (that is, void of crystallinity) and are polymerized either from meso-lactide or from equimolar (racemic) combinations of d-lactide and l-lactide. The poly(dl-lactide-co-glycolide) copolymers covered by this specification are also considered to be amorphous and are co-polymerized from a combination of glycolide and either meso-lactide or racemic quantities of d-lactide and l-lactide, and typically possess nominal mole fractions that equal or exceed 50 % lactide.
1.2 Since poly(glycolide) is commonly abbreviated as PGA for poly(glycolic acid) and poly(lactide) is commonly abbreviated as PLA for poly(lactic acid), these polymers are commonly referred to as PGA, PLA, and PLA:PGA resins for the hydrolytic byproducts to which they respectively degrade. PLA is a term that carries no stereoisomeric specificity and therefore encompasses both the amorphous atactic/syndiotactic dl-lactide-based polymers and copolymers as well as the isotactic d-PLA and l-PLA moieties, each of which carries potential for crystallization. Therefore, specific reference to dl-PLA is essential to appropriately differentiate the amorphous atactic/syndiotactic dl-lactide-based polymers and copolymers covered by this specification. Thus, inclusion of stereoisomeric specificity within the lactic acid-based acronyms results in the following: poly(l-lactide) as PlLA for poly(l-lactic acid), poly(d-lactide) as PdLA for poly(d-lactic acid), and poly(dl-lactide) as PdlLA for poly(dl-lactic acid).
1.3 This specification covers virgin amorphous poly(lactide)-based resins able to be fully solvated at 30°C by either methylene chloride (dichloromethane) or chloroform (trichloromethane). This specification is not applicable to lactide-based polymers or copolymers that possess isotactic polymeric segments sufficient in size to carry potential for lactide-based crystallization, which are covered by Specification F1925 and typically possess nominal mole fractions that equal or exceed 50 % l-lactide. This specification is not applicable to lactide-co-glycolide copolymers that possess glycolide segments sufficient in size to deliver potential for glycolide-based crystallization, thereby requiring fluorinated solvents for complete dissolution under room temperature conditions. This specification is specifically not applicable to lactide-co-glycolide copolymers with glycolide mole fractions greater than or equal to 70 % (65.3 % in mass fraction), which are covere...
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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: F2579 −18
Standard Specification for
Amorphous Poly(lactide) and Poly(lactide-co-glycolide)
1
Resins for Surgical Implants
This standard is issued under the fixed designation F2579; 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 polymeric segments sufficient in size to carry potential for
lactide-based crystallization, which are covered by Specifica-
1.1 Thisspecificationcoversvirginamorphouspoly(lactide)
tion F1925 and typically possess nominal mole fractions that
homopolymer and poly(lactide-co-glycolide) copolymer resins
equal or exceed 50 % L-lactide. This specification is not
intended for use in surgical implants. The poly(DL-lactide)
applicable to lactide-co-glycolide copolymers that possess
homopolymers covered by this specification are considered to
glycolide segments sufficient in size to deliver potential for
be amorphous (that is, void of crystallinity) and are polymer-
glycolide-based crystallization, thereby requiring fluorinated
ized either from meso-lactide or from equimolar (racemic)
combinations of D-lactide and L-lactide. The poly(DL-lactide-
solvents for complete dissolution under room temperature
co-glycolide) copolymers covered by this specification are also
conditions. This specification is specifically not applicable to
considered to be amorphous and are co-polymerized from a
lactide-co-glycolide copolymers with glycolide mole fractions
combination of glycolide and either meso-lactide or racemic
greater than or equal to 70 % (65.3 % in mass fraction), which
quantities of D-lactide and L-lactide, and typically possess
are covered by Specification F2313. This specification is not
nominal mole fractions that equal or exceed 50 % lactide.
applicable to block copolymers or to polymers or copolymers
1.2 Since poly(glycolide) is commonly abbreviated as PGA synthesized from combinations of D-lactide and L-lactide that
for poly(glycolic acid) and poly(lactide) is commonly abbre- differ by more than 1.5 total mole percent (1.5 % of total
viated as PLA for poly(lactic acid), these polymers are com-
moles).
monly referred to as PGA, PLA, and PLA:PGA resins for the
1.4 This specification addresses material characteristics of
hydrolyticbyproductstowhichtheyrespectivelydegrade.PLA
both poly(DL-lactide) and poly(DL-lactide-co-glycolide) resins
isatermthatcarriesnostereoisomericspecificityandtherefore
intended for use in surgical implants and does not apply to
encompasses both the amorphous atactic/syndiotactic DL-
packaged and sterilized finished implants fabricated from these
lactide-based polymers and copolymers as well as the isotactic
materials.
D-PLAand L-PLAmoieties, each of which carries potential for
crystallization. Therefore, specific reference to DL-PLA is
1.5 As with any material, some characteristics may be
essential to appropriately differentiate the amorphous atactic/
altered by processing techniques (such as molding, extrusion,
syndiotactic DL-lactide-based polymers and copolymers cov-
machining, assembly, sterilization, and so forth) required for
ered by this specification. Thus, inclusion of stereoisomeric
the production of a specific part or device. Therefore, proper-
specificity within the lactic acid-based acronyms results in the
ties of fabricated forms of this resin should be evaluated
following: poly(L-lactide) as PLLA for poly(L-lactic acid),
independently using appropriate test methods to assure safety
poly(D-lactide) as PDLA for poly(D-lactic acid), and poly(DL-
and efficacy.
lactide) as PDLLA for poly(DL-lactic acid).
1.6 The values stated in SI units are to be regarded as
1.3 This specification covers virgin amorphous
standard. No other units of measurement are included in this
poly(lactide)-based resins able to be fully solvated at 30°C by
standard.
either methylene chloride (dichloromethane) or chloroform
(trichloromethane). This specification is not applicable to
1.7 This standard does not purport to address all of the
lactide-based polymers or copolymers that possess isotactic
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter-
1
This specification is under the jurisdiction of ASTM Committee F04 on
mine the applicability of regulatory limitations prior to use.
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.11 on Polymeric M
...
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: F2579 − 10 F2579 − 18
Standard Specification for
Amorphous Poly(lactide) and Poly(lactide-co-glycolide)
1
Resins for Surgical Implants
This standard is issued under the fixed designation F2579; 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 specification covers virgin amorphous poly(lactide) homopolymer and poly(lactide-co-glycolide) copolymer resins
intended for use in surgical implants. The poly(DL-lactide) homopolymers covered by this specification are considered to be
amorphous (that is, void of crystallinity) and are polymerized either from meso-lactide or from equimolar (racemic) combinations
of D-lactide and L-lactide. The poly(DL-lactide-co-glycolide) copolymers covered by this specification are also considered to be
amorphous and are co-polymerized from a combination of glycolide and either meso-lactide or racemic quantities of D-lactide and
L-lactide, and typically possess nominal mole fractions that equal or exceed 50 % lactide.
1.2 Since poly(glycolide) is commonly abbreviated as PGA for poly(glycolic acid) and poly(lactide) is commonly abbreviated
as PLA for poly(lactic acid), these polymers are commonly referred to as PGA, PLA, and PLA:PGA resins for the hydrolytic
byproducts to which they respectively degrade. PLA is a term that carries no stereoisomeric specificity and therefore encompasses
both the amorphous atactic/syndiotactic DL-lactide-based polymers and copolymers as well as the isotactic D-PLA and L-PLA
moieties, each of which carries potential for crystallization. Therefore, specific reference to DL-PLA is essential to appropriately
differentiate the amorphous atactic/syndiotactic DL-lactide-based polymers and copolymers covered by this specification. Thus,
inclusion of stereoisomeric specificity within the lactic acid-based acronyms results in the following: poly(L-lactide) as PLLA for
poly(L-lactic acid), poly(D-lactide) as PDLA for poly(D-lactic acid), and poly(DL-lactide) as PDLLA for poly(DL-lactic acid).
1.3 This specification covers virgin amorphous poly(lactide)-based resins able to be fully solvated at 30°C by either methylene
chloride (dichloromethane) or chloroform (trichloromethane). This specification is not applicable to lactide-based polymers or
copolymers that possess isotactic polymeric segments sufficient in size to carry potential for lactide-based crystallization, which
are covered by Specification F1925 and typically possess nominal mole fractions that equal or exceed 50 % L-lactide. This
specification is not applicable to lactide-co-glycolide copolymers that possess glycolide segments sufficient in size to deliver
potential for glycolide-based crystallization, thereby requiring fluorinated solvents for complete dissolution under room
temperature conditions. This specification is specifically not applicable to lactide-co-glycolide copolymers with glycolide mole
fractions greater than or equal to 70 % (65.3 % in mass fraction), which are covered by Specification F2313. This specification is
not applicable to block copolymers or to polymers or copolymers synthesized from combinations of D-lactide and L-lactide that
differ by more than 1.5 total mole percent (1.5 % of total moles).
1.4 This specification addresses material characteristics of both poly(DL-lactide) and poly(DL-lactide-co-glycolide) resins
intended for use in surgical implants and does not apply to packaged and sterilized finished implants fabricated from these
materials.
1.5 As with any material, some characteristics may be altered by processing techniques (such as molding, extrusion, machining,
assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated
forms of this resin should be evaluated independently using appropriate test methods to assure safety and efficacy.
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.7 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.
1.8 This international standard wa
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