Physical chemical stability of warfarin sodium

Physical chemical stability of warfarin sodium

Crystalline warfarin sodium is an isopropanol clathrate containing 8.3% isopropyl alcohol (IPA) and 0.57% water upon receipt. The hygroscopicity and impact of moisture on IPA status as well as on the stability of the clathrate was studied at different relative humidities. The IPA loss and water upta...

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Veröffentlicht in:AAPS PharmSci 2001, Vol.3 (1), p.E3-25
Hauptverfasser: Gao, D, Maurin, M B
Format: Artikel
Sprache:eng
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2-Propanol
Calorimetry, Differential Scanning
Crystallization
Crystallography, X-Ray
Drug Stability
Solvents
Thermogravimetry
Warfarin - chemistry
Water
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description Crystalline warfarin sodium is an isopropanol clathrate containing 8.3% isopropyl alcohol (IPA) and 0.57% water upon receipt. The hygroscopicity and impact of moisture on IPA status as well as on the stability of the clathrate was studied at different relative humidities. The IPA loss and water uptake were simultaneous but they did not exchange at 1:1 molar ratio. At 58% relative humidity (RH) or below, the exchange process was insignificant. At 68% RH or above, the clathrate tended to lose IPA while absorbing water and reverting to the amorphous state. The rate of IPA loss and moisture uptake was a function of RH. The thermal stability of the crystalline warfarin sodium was also examined. Physical change occurred after isothermal storage for 24 hours at 80 degrees C and 11 hours at 120 degrees C. The rate of IPA loss was temperature dependent.
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subjects 2-Propanol
Calorimetry, Differential Scanning
Crystallization
Crystallography, X-Ray
Drug Stability
Solvents
Thermogravimetry
Warfarin - chemistry
Water
title Physical chemical stability of warfarin sodium
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