Advanced Search
CHEN Mengyi, YIN Hui, LIU Xiaohui, DI Bin. Study on extractables in disposable syringe materials[J]. Journal of China Pharmaceutical University, 2017, 48(5): 583-589. DOI: 10.11665/j.issn.1000-5048.20170513
Citation: CHEN Mengyi, YIN Hui, LIU Xiaohui, DI Bin. Study on extractables in disposable syringe materials[J]. Journal of China Pharmaceutical University, 2017, 48(5): 583-589. DOI: 10.11665/j.issn.1000-5048.20170513

Study on extractables in disposable syringe materials

More Information
  • Extraction experiment of volatile compounds in disposable syringes from five manufacturers was undertaken by GC-MS with high-space injection and semi-volatile compounds were tested by GC-MS. MS detection ranged from 30 to 650 with electron ionization(EI)source. Vanillin was used as internal standard to monitor the sample pretreatment process. Liquid-liquid extraction(LLE)and solid-phase extraction(SPE)were compared to acquire a simple processing method with more extractables in syringe materials. HCl, NaOH, Tween 80 and ethanol-aqueous solution were used as extraction solvents. The method was successfully developed to determine the unknown volatile extractables and the results were used to investigate the safety of disposable syringes comprehensively.
  • [1]
    Liu XH,Yin H,Yan H,et al.Compatibility of pre-filled syringes with pharmaceutical products[J].J China Pharm Univ(中国药科大学学报),2016,47(3):275-281.
    [2]
    Paskiet D, Jenke D, Ball D, et al. The product quality research institute(PQRI)leachables and extractables working group initiatives for parenteral andophthalmic drug product(PODP)[J].PDA J Pharm Sci Technol,2012,67(5):430-447.
    [3]
    Jenke D,Odufu A,Couch T,et al.Evaluation of the general solution compatibility of polymer materials used in medical devices such as syringes[J].PDA J Pharm Sci Technol,2012,66(4):286-306.
    [4]
    Vieira MGA,Silva MAD,Santos LOD,et al.Natural-based plasticizers and biopolymer films:a review[J].Eur Polymr J,2011,47(3):254-263.
    [5]
    Oehlmann J,Schulte-Oehlmann U,Kloas W,et al.A critical analysis of the biological impacts of plasticizers on wildlife[J].Phil Trans R Soc B,2009,364(1526):2047-2062.
    [6]
    Zhou Q,Zhu L.Adsorption of 5 cardiovascular drugs by disposable syringe in intravenous administration via micro-pump[J].Chin J Clin Pharm(中国临床药学杂志),2000,9(5):301-302.
    [7]
    China Food and Drug Administration.Technical guidelines for the research on the compatibility of chemical medicine injection and plastic packing materials(化学药品注射剂与塑料包装材料相容性研究技术指导原则)[S].2012.9.
    [8]
    Jenke D,Castner J,Egert T,et al.Extractables characterization for five materials of construction representative of packaging systems used for parenteral and ophthalmic drug products[J].PDA J Pharm Sci Technol,2013,67(5):448-511.
  • Related Articles

    [1]Separation of the Main Impurity P-demethylgatifloxacin from Gatifloxacin and its Synthesis and Identification[J]. Journal of China Pharmaceutical University, 2003, (3): 78-79.
    [2]WU Ru-Jin, CHEN Yu-Ying, JI Yi-Bing. Separation of Ephedrine Isomers with Non-aqueous Capillary Electrophoresis[J]. Journal of China Pharmaceutical University, 2001, (3): 55-58.
    [3]Separation andDetermination of Cefaclor in Human Plasma by High Performance Capillary Electrophoresis[J]. Journal of China Pharmaceutical University, 2000, (4): 27-30.
    [4]Enzymatic Production of L Serine and Separation of Amino Acids from Reaction Solution[J]. Journal of China Pharmaceutical University, 2000, (2): 57-60.
    [5]Separation and Analysis of Five Organic Acids in Autotetraploid Radix Isatidis by Capillary Electrophoresis[J]. Journal of China Pharmaceutical University, 2000, (2): 33-36.
    [6]System Separation of Cyclosporin A Triple Therapeutic Drugs by Micellar Electrokinetic Capillary Chromatography and Evaluation of Optimal Method Ruggedness[J]. Journal of China Pharmaceutical University, 1999, (5): 373-376.
    [7]Separation of Trans and Cis Crocin in Saffron Using HPLC and Study on Their Pharmacological Activities[J]. Journal of China Pharmaceutical University, 1999, (2): 30-33.
    [8]Ji Yibing, Chen Yuying, Lin Bingcheng. Capillary Electrophoresis for Separation of Drug Enantiomers Using Different Cyclodextrins as Chiral Selectors[J]. Journal of China Pharmaceutical University, 1996, (6).
    [10]Study on Joule Heat in the Separation of High Performance Capillary Electrophoresis[J]. Journal of China Pharmaceutical University, 1996, (2): 87-90.

Catalog

    Article views (1024) PDF downloads (1344) Cited by()

    /

    DownLoad:  Full-Size Img  PowerPoint
    Return
    Return