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View Paper |
Session Topic: 4E, Pharmaceutical Metrology |
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Paper Title: Issues to Consider When Complying with ICH Guidelines Involving Temperature and Relative Humidity Conditions |
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Date & Time: TUESDAY, August 6, 2002 |
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10:45am - 12:15pm PARALLEL SESSIONS - SESSION 4 |
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Speaker: Clay Hile
Parameter Generation & Control, Inc. |
Email: c.hile@humidiycontrol.com |
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ICH publication “Stability Testing of New Drug Substances and Products” prescribes several temperature and humidity conditions to maintain during stability testing. Typically the environment specification stipulates a specific temperature with a ± 2.0°C tolerance and a relative humidity with a ± 5.0% tolerance (example: 25°C ± 2°C/60% RH ± 5% RH). To properly achieve these specifications, three parameters must be considered. They are: sensor accuracy, single point control constancy, and entire chamber uniformity or stratification. The product tested will be at the proper condition when the sum of these parameters are within the prescribed tolerance. This prescribed tolerance applies to both temperature and relative humidity. |
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