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Low temperature stability
Low temperature stability for physicochemical properties testing assesses the test substance under freeze/thaw temperature cycling conditions (for capsule suspensions). This is usually between room temperature (e.g. 20 ± 2°C) and -10 ± 2°C on 18-hour-freeze/6-hour-melt cycles for a total of 4 cycles. If crystallization or phase separation is likely to occur for liquid preparations, then tests should be completed at 0°C or lower. For storage purposes, the phrase 'Protect from Frost' must be included on the label if the substance is adversely affected by these conditions.
