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    Solutions for Nitrosamine Analysis - GC-MS/MS and LC-HRMS Method-​

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    Solutions for Nitrosamine Analysis - GC-MS/MS and LC-HRMS Method-​

     

    The USFDA has extensively investigated the presence of nitrosamines (NSAs), a type of genotoxic impurity, in various drugs, and has recently expanded the list of identified nitrosamines for monitoring.​
    Read more below to learn how Shimadzu can meet your nitrosamine analysis needs, from routine lot and batch testing to present and future drug discovery.

    Trace Level Quantitation of 6 Nitrosamines in Metformin API by Dynamic Headspace GC-MS/MS

    Trace Level Quantitation of 6 Nitrosamines in Metformin API by Dynamic Headspace GC-MS/MS

     

     

    GCMS-TQ8050 NX, HS-20

    User Benefits

    • Dynamic headspace equipped with GC-MS/MS was used for trace level quantitation of Nitrosamines in Metformin API
    • GCMS-TQ8050 NX system equipped with HS-20 easily meets the criteria as per the regulatory guidelines on Nitrosamines
    • Compared to static headspace, dynamic headspace has advantage in trace level detection of Nitrosamines

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    Quantitation of 5 Nitrosamines in Metformin API and Formulation by HS-GCMS/MS

    Quantitation of 5 Nitrosamines in Metformin API and Formulation by HS-GCMS/MS

     

    GCMS-TQ8040 NX, HS-20​

    User Benefits​

    • A HS-GCMS/MS method for the determination of 5 Nitrosamines in Metformin API & formulation
    • The GCMS-TQ8040 NX system easily meets the criteria as per the USFDA guidance on Nitrosamines

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    Detection and Quantitation of Nitrosamine Impurities in Drug Substances by LC-HRMS on LCMS-9030

    Detection and Quantitation of Nitrosamine Impurities in Drug Substances by LC-HRMS on LCMS-9030

     

     

    LCMS-9030​

    User Benefits​

    • Simultaneous analysis of up to eight N-nitrosamine impurities in drug substances by LC-HRMS method on LCMS-9030.
    • A targeted MS/MS (TOF) method with 2 m/z isolation window by the quadrupole was optimized to obtain best sensitivity.
    • A mass tolerance of (±)15 ppm was adopted to produce extracted-ion chromatograms (XICs) for quantitation.​

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