- 专利标题: METHOD FOR DETERMINING RESIDUAL ALDEHYDES RELEASABLE FROM A SYRINGE
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申请号: EP22162231.9申请日: 2022-03-15
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公开(公告)号: EP4067896A1公开(公告)日: 2022-10-05
- 发明人: BESSEGATO, Nicola , CAMPESATO, Lara , SFULCINI, Alberto
- 申请人: Nuova Ompi S.r.l.
- 申请人地址: IT 35017 Piombino Dese (PD) Via Molinella, 17
- 代理机构: Long, Giorgio
- 优先权: IT202100007835 20210330
- 主分类号: G01N30/06
- IPC分类号: G01N30/06 ; G01N30/88 ; A61M5/178 ; G01N1/28
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.
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.
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