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Briefly Explain About Ich Climatic Zones For Stability Testing & Long Term Storage Conditions? |
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Answer» ICH STABILITY ZONES: Zone: Type of Climate Zone I: Temperate zone Zone II: Mediterranean/subtropical zone Zone III: Hot dry zone Zone IVA: Hot humid/tropical zone Zone IVb:
Minimum Duration: Zone I: 21ºC ± 2ºC 45% rH ± 5% rH 12 Months Zone II: 25ºC ± 2ºC 60% rH ± 5% rH 12 Months Zone III: 30ºC ± 2ºC 35% rH ± 5% rH 12 Months Zone IV: 30ºC ± 2ºC 65% rH ± 5% rH 12 Months Zone IVb: 30ºC ± 2ºC 75% rH ± 5% rH 12 Months Refrigerated 5ºC ± 3ºC No Humidity 12 Months -15ºC ± 5ºC No Humidity 12 Months ICH STABILITY ZONES: Zone: Type of Climate Zone I: Temperate zone Zone II: Mediterranean/subtropical zone Zone III: Hot dry zone Zone IVa: Hot humid/tropical zone Zone IVb: Minimum Duration: Zone I: 21ºC ± 2ºC 45% rH ± 5% rH 12 Months Zone II: 25ºC ± 2ºC 60% rH ± 5% rH 12 Months Zone III: 30ºC ± 2ºC 35% rH ± 5% rH 12 Months Zone IV: 30ºC ± 2ºC 65% rH ± 5% rH 12 Months Zone IVb: 30ºC ± 2ºC 75% rH ± 5% rH 12 Months Refrigerated 5ºC ± 3ºC No Humidity 12 Months Frozen -15ºC ± 5ºC No Humidity 12 Months |
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