Determination of elemental impurities in leachate solutions from syringes using sector field ICP-mass spectrometry

• Published in: Journal of pharmaceutical and biomedical analysis 2013-04, Vol.77, p.139-144
• Main Authors: Van Hoecke, K., Catry, C., Vanhaecke, F.
• Format: Article
• Language: English
• Subjects: Drug Contamination; Elemental impurities; Guideline; ICP-MS; Leachables; Mass Spectrometry - methods; Prefilled syringes; Solutions - chemistry; Spectrophotometry, Atomic - methods; Syringes
• ISSN: 0731-7085; 1873-264X
• DOI: 10.1016/j.jpba.2013.01.021

[Display omitted] ► Leaching of elemental impurities from glass syringes was assessed using sector field ICP-MS. ► Sixteen elements defined in draft USP chapter 232, Na, Al, Si, and W were determined. ► All leachate solutions contained Na and Si, up to 1200 and 4500μgL−1, respectively. ► Al, As and W leached in variable amounts from syringes of one manufacturer. ► Harmonization of test and limit concentration guidelines would be beneficial. Prefilled syringes are of increasing importance on the drug product market. Drug products supplied in prefilled syringes have to comply with guidelines on elemental impurity limit concentrations. Elemental impurities may be introduced through any reagents or catalysts used or any product contact surface. This work addresses the determination of elemental impurities leaching from three types of glass syringe container-closure systems supplied by two leading manufacturers. Leachate solutions of every type of syringe were analyzed for Na, Al, Si, W and the 16 elements listed in draft USP chapter 232, which were selected on grounds of toxicity. Elemental impurity concentrations were determined using sector field ICP-mass spectrometry. Significant concentrations of Na and Si were found in all leachate solutions, up to 1200 and 4500μgL−1, respectively. In addition, also Al, As and W were leached out of syringes from one manufacturer in variable amounts, giving rise to average concentrations (std. dev., n=6) of 400 (120), 0.55 (0.08) and 230 (220)μgL−1, respectively. So far, no exceeding of limit concentrations was observed.