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  • 1.  Acrylamide monomers Benchmark

    This message was posted by a user wishing to remain anonymous
    Posted 04-Oct-2018 10:24
    This message was posted by a user wishing to remain anonymous

    Hi everyone, we are developing a lubricant for joint problems,  because It contains polyacrylamide gel, we need to monitor the acrylamide monomers residue. Can anyone tell me the acrylamide monomers benchmark in different countries (USA,Canada, China, EU......)?
    Any input is appreciated

    Thanks in advance

    Jen


  • 2.  RE: Acrylamide monomers Benchmark

    Posted 07-Oct-2018 14:06
    Dear Colleague,

    due to the bad reputation of polyacrylamide injections in human treatment and as the intraarticular injections of lubricants generally are not regarded to be more effective, than oral NSAIDS, probably this development plan would not get much support.

    Regards

    ------------------------------
    Peter Mikó M.D
    ArtPharm Ltd.
    Gyermely
    Hungary
    ------------------------------

    Original Message


  • 3.  RE: Acrylamide monomers Benchmark

    Posted 08-Oct-2018 07:52
    Hello there,

    This group does have qualified toxicologists in its midst, but frankly your question is one for your consulting toxicologist to answer and write formal safety qualification for this.  I suspect you will be looking at ADME studies anyway.

    ------------------------------
    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
    ------------------------------

    Original Message


  • 4.  RE: Acrylamide monomers Benchmark

    Posted 07-Oct-2018 22:33
    Edited by Sam Lazzara 07-Oct-2018 22:35
      |   view attached
    About 14 years ago I was working on an implantable vascular embolization 510(k) device that was based on an acrylonitrile polymer that utilized acrylamide as a starting monomer. We attempted to use exhaustive <g class="gr_ gr_22 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del multiReplace" id="22" data-gr-id="22">extractables</g> testing to demonstrate acceptable risk. The residual <g class="gr_ gr_55 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del multiReplace" id="55" data-gr-id="55">acyrlamide</g> monomer amount was less than 20 parts per billion, 20 nanograms per gram, which was our testing detection limit. FDA rejected our risk assessment, and forced our hand to perform a carcinogenicity study and we ultimately achieved clearance after passing a 6-month transgenic mouse study.

    (Our argument that acrylamide can be found in potato chips and french fries was not submitted)

    I have attached an old compilation of acrylonitrile info that I prepared at that time - 2004.
    This does not answer your question directly, but I hope it helps.

    ------------------------------
    Sam Lazzara
    Principal Consultant
    Fremont CA & Las Vegas NV USA
    https://mdqc.blog/
    ------------------------------

    Attachment(s)

    doc
    Acrylonitrile Info on the Web (2007 or so).doc   332 KB 1 version
    Original Message


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