METHOD FOR DETERMINING RESIDUAL ALDEHYDES RELEASABLE FROM A SYRINGE

    公开(公告)号:EP4067896A1

    公开(公告)日:2022-10-05

    申请号:EP22162231.9

    申请日:2022-03-15

    申请人: Nuova Ompi S.r.l.

    摘要: The present invention relates to a method for extracting aldehydes from the adhesive used for gluing needles to syringes, and to a method for determining the aldehydes releasable from said syringes, before or after such a treatment.
    In particular, the present invention relates to a analytical method for detecting residual aldehydes releasable from a syringe (1), wherein said syringe is a syringe (1)-needle (3) assembly, wherein the needle (3) is coupled to the cone (2) of the syringe (1) by means of an adhesive or glue (4) containing residual aldehydes, the method comprising the following steps:
    iii) preparation of the sample to be analysed by isolating the cone (2) of the syringe (1) comprising the needle portion (3) inserted in it and the glue (4) ;
    iv) derivatization treatment of the sample of step i) with a compound of formula Ar-NH-NH 2 , wherein Ar is a phenyl substituted with one or more electron-attractant groups;
    iii) analysis of the solution resulting from step ii) by reverse-phase HPLC coupled to UV detector.