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<p>This study addresses the issue of hazardous leachables specifically 2-mercaptobenzothiazole and 1,3-diphenylguanidine, which originate from vulcanizing agents and additives in pharmaceutical container materials. These compounds can negatively affect the quality and safety of pharmaceutical products by leaching out within the temperature range of 30–70&#xa0;°C, which overlaps with typical daily life conditions. We developed a sensitive and robust UHPLC–MS/MS mass spectrometric method for the simultaneous quantification of primary leachables in pharmaceutical container systems. Chromatographic separation was performed on an ACQUITY UPLC CSH C<sub>18</sub> column (2.1 × 100&#xa0;mm, 1.7&#xa0;µm) using a binary mobile phase consisting of 0.1% formic acid in water (solvent A) and acetonitrile (solvent B) under a gradient elution program at a flow rate of 0.15&#xa0;mL/min. Detection was carried out on a triple quadrupole mass spectrometer operated in a selective reaction monitoring (SRM) mode, ensuring high sensitivity and selectivity for target analytes. The developed UHPLC–MS/MS (ultra-liquid chromatography coupled with tandem mass spectrometry) method was validated and applied to quantify targeted compounds in selected pharmaceutical containers. This method demonstrated limits of detection (LOD) ranging from 1.13 to 1.18&#xa0;ppb for the leachables, with a linearity range of 0.001&#xa0;µg/mL–2&#xa0;µg/mL. In this investigation, the detected leachables exceeded the established safety concern threshold (SCT), indicating that the pharmaceutical containers may pose potential toxicological risks to patients.</p>

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Simultaneous LC–MS/MS Determination of Primary Leachables from Pharma Receptacles: 2-Mercaptobenzothiazole and 1,3-Diphenylguanidine

  • 期刊论文

  • 发表日期：

    2026年5月21日

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  • Hemasree Kommalapati,
  • Sowmya Chaganti,
  • Pushpa Pilli,
  • Kavita Pimpre,
  • Gananadhamu Samanthula

摘要

This study addresses the issue of hazardous leachables specifically 2-mercaptobenzothiazole and 1,3-diphenylguanidine, which originate from vulcanizing agents and additives in pharmaceutical container materials. These compounds can negatively affect the quality and safety of pharmaceutical products by leaching out within the temperature range of 30–70 °C, which overlaps with typical daily life conditions. We developed a sensitive and robust UHPLC–MS/MS mass spectrometric method for the simultaneous quantification of primary leachables in pharmaceutical container systems. Chromatographic separation was performed on an ACQUITY UPLC CSH C18 column (2.1 × 100 mm, 1.7 µm) using a binary mobile phase consisting of 0.1% formic acid in water (solvent A) and acetonitrile (solvent B) under a gradient elution program at a flow rate of 0.15 mL/min. Detection was carried out on a triple quadrupole mass spectrometer operated in a selective reaction monitoring (SRM) mode, ensuring high sensitivity and selectivity for target analytes. The developed UHPLC–MS/MS (ultra-liquid chromatography coupled with tandem mass spectrometry) method was validated and applied to quantify targeted compounds in selected pharmaceutical containers. This method demonstrated limits of detection (LOD) ranging from 1.13 to 1.18 ppb for the leachables, with a linearity range of 0.001 µg/mL–2 µg/mL. In this investigation, the detected leachables exceeded the established safety concern threshold (SCT), indicating that the pharmaceutical containers may pose potential toxicological risks to patients.