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    ICH Stability Zones

    Uploaded by

    Jan Wyrwas
    The document defines six ICH stability zones based on climate conditions and lists the long term testing conditions required for each zone, including temperature, humidity, and minimum duration of 12 months. It also specifies the accelerated and intermediate testing conditions, requiring temperatures of 25-40°C, humidity levels of 60-75% RH, and minimum durations of 6 months.

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    ICH Stability Zones

    Uploaded by

    Jan Wyrwas
    632 views1 page
    The document defines six ICH stability zones based on climate conditions and lists the long term testing conditions required for each zone, including temperature, humidity, and minimum duration of 12 months. It also specifies the accelerated and intermediate testing conditions, requiring temperatures of 25-40°C, humidity levels of 60-75% RH, and minimum durations of 6 months.

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    The document defines six ICH stability zones based on climate conditions and lists the long term testing conditions required for each zone, including temperature, humidity, and minimum duration of 12 months. It also specifies the accelerated and intermediate testing conditions, requiring temperatures of 25-40°C, humidity levels of 60-75% RH, and minimum durations of 6 months.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    632 views1 page

    ICH Stability Zones

    Uploaded by

    Jan Wyrwas
    The document defines six ICH stability zones based on climate conditions and lists the long term testing conditions required for each zone, including temperature, humidity, and minimum duration of 12 months. It also specifies the accelerated and intermediate testing conditions, requiring temperatures of 25-40°C, humidity levels of 60-75% RH, and minimum durations of 6 months.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 1

    ICH Stability Zones

    Zone Type of Climate


    Zone I Temperate zone
    Zone II Mediterranean/subtropical zone
    Zone III Hot dry zone
    Zone IV Hot humid/tropical zone
    Zone IVb ASEAN testing conditions hot/higher humidity
    Long Term Testing Conditions
    Climatic Zone Temperature Humidity Minimum Duration
    Zone I 21C 2C 45% rH 5% rH 12 Months
    Zone II 25C 2C 60% rH 5% rH 12 Months
    Zone III 30C 2C 35% rH 5% rH 12 Months
    Zone IV 30C 2C 65% rH 5% rH 12 Months
    Zone IVb 30C 2C 75% rH 5% rH 12 Months
    Refrigerated 5C 3C No Humidity 12 Months
    Frozen -15C 5C No Humidity 12 Months

    Accelerated and Intermediate Testing Conditions
    Climatic Zone Temperature Humidity Minimum Duration
    Accelerated Ambient 40C 2C 75% rH 5% rH 6 Months
    Accelerated Refrigerated 25C 2C 60% rH 5% rH 6 Months
    Accelerated Frozen 5C 3C No Humidity 6 Months
    Intermediate 30C 2C 65% rH 5% rH 6 Months

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