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Table 1 A side-by-side comparison of the experimental conditions for the three stability methods used herein

From: Non-isothermal stability by linear heating: a fast method for preformulation stability screening of drugs at the discovery and development interface

  Non-Isothermal (LNISO) Stability Abbreviated Isothermal Stability Conventional Isothermal Stability
Drug Substance Concentration 40 ppm 40 ppm 40 ppm
Vehicle 80:20 (~30 mM Phosphate Buffer/Ethanol) 80:20 (~30 mM Phosphate Buffer/Ethanol) 80:20 (~30 mM Phosphate Buffer/Ethanol)
Target pH Starting pH: 7.0, End pH: shifted by ≤ 0.2 pH-unit due to the temp. increase 7.0 7.0
Heating Type/Storage Temperatures Linear Heating (50 – 95 °C) Isothermal (50, 60, and 80 °C) Isothermal (40, 50, 60, and 80 °C)
Target Time Points 0, 8, 32, 56, 80, 104, 120, 128, 144, 152, 168 h 0, 3, 7, 14 and 28 days 0, 3, 7, 14, 28, 42 and 56 days
Sample Storage Time 7 days 4 weeks 8 weeks
Total Number of Samples 11 13 25