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Stability Storage and Testing

VIMTA has one of the largest Stability storage comprising several walk-in rooms with a cumulative capacity of 180,000 liters to cover a wide range of environmental conditions such as:

5°C ---- Refrigerated condition
25°C ---- Ambient humidity
25°C / 60% R.H. ---- Primary ICH long term condition
30ºC / 65% R.H ---- Intermediate ICH condition
30°C / 60% R.H ---- Intermediate ICH condition
40°C / 75% R.H. ---- Accelerated ICH condition
Photostability ---- ICH option 1 and 2

Custom storage conditions can be programmed to meet customer requirements.

Stability laboratory is supported by manual / semi-automated / automated dissolution apparatus such as CALIPER Multi Dose G3 and Tablet Process Work station (TPW) for uniformity testing.

Chromatographic data is analysed through WATERS EMPOWER and LABWARE LIMS.

   
 
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