Simultaneous Determination of 16 Elemental Impurities in Methylparaben and Propylparaben Using Ultra Microwave-Assisted Digestion and Inductively Coupled Plasma Mass Spectrometry(ICP-MS)
Objective:To establish a method for detecting elemental impurities that complies with regulatory requirements and to investigate the residual levels of elemental impurities in the preservatives methylparaben and propylparaben.Methods:Samples were prepared by advanced microwave digestion and analyzed by Inductively Coupled Plasma Mass Spectrometry(ICP-MS)for the detection of elemental impurities.The developed method was applied to assess the levels of 16 elemental impurities across multiple batches of methylparaben and propylparaben from various manufacturers.Results:The method demonstrated compliance with regulatory standards in terms of linearity,detection limits,quantitation limits,accuracy,and precision.Most batches had elemental impurity levels below the control thresholds for inhalation administration.However,certain batches exhibited nickel(Ni),chromium(Cr),and vanadium(V)levels exceeding these thresholds.Conclusion:The developed method is suitable for the quantitative screening of multiple elemental impurities in methylparaben and propylparaben.Overall,the risk of elemental impurities is relatively low when these preservatives are used in high-risk inhalation formulations,though specific manufacturers should address potential residual risks associated with Ni,Cr,and V.
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