Stability Storage and Testing
VIMTA has one of the largest Stability storage comprising several walk-in rooms with a cumulative capacity of 230000 liters to cover a wide range of environmental conditions such as:
| Specification |
|
Description |
| 5°C |
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Refrigerated condition |
| 25°C / 60% R.H. |
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Primary ICH long term condition |
| 30 °C / 75 % RH |
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Intermediate ICH condition |
| 30 °C / 60 % RH |
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Intermediate ICH condition |
| 40 °C / 75 % RH |
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Accelerated ICH condition |
| Photostability |
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ICH option 1 and 2 with light intensity recording facility |
Custom storage conditions can be programmed to meet customer requirements. Online temperature and RH Data recording and backup facility available.
Stability laboratory is supported by manual / semi-automated / automated dissolution apparatus such as CALIPER Multi Dose G3 , Tablet Processing Work station (TPW) for uniformity testing and Waters HPLCs connected to Empower server.
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