Wy. Kuu et al., EFFECT OF RELATIVE-HUMIDITY AND TEMPERATURE ON MOISTURE SORPTION AND STABILITY OF SODIUM-BICARBONATE POWDER, International journal of pharmaceutics, 166(2), 1998, pp. 167-175
The effects of relative humidity and temperature on moisture sorption
rate and stability profile of sodium bicarbonate powder exposed to var
ious storage conditions were investigated using gravimetrical and acid
-titration methods. In the study, samples were placed in desiccators,
which contained various saturated salt solutions to generate desired l
evels of relative humidity, denoted as RH, ranging from 30-93% RH. The
weight of each sample was determined periodically. The results show t
hat both the temperature and relative humidity are key factors in mois
ture sorption isotherm and decomposition kinetics. The threshold relat
ive humidity RHth is defined as the relative humidity above which sodi
um bicarbonate powder starts to rapidly gain weight. The critical rela
tive humidity RHc is defined as the relative humidity above which sodi
um bicarbonate powder either starts to rapidly gain weight or starts t
o rapidly hydrolyze (resulting in losing weight). The moisture sorptio
n isotherm shows an unusual phenomenon at high RH, where the weight of
the sodium bicarbonate powder either increases or decreases with time
, depending on the storage temperature. When the powder is exposed to
a lower temperature and high humidity level (e.g. at 25 degrees C and
93% RH), the weight increases rapidly, due to the fact that the relati
ve humidity exceeds the RHth at this temperature. On the other hand, w
hen the powder is exposed to higher temperature and high humidity leve
ls (e.g. at 40 degrees C, 89% RH and at 55 degrees C, 82% RH), the wei
ght of the powder decreases with time since the relative humidity is b
elow the RHth at these temperature levels and the decomposition rate i
s higher than the moisture sorption rate. The decomposition of sodium
bicarbonate results in the release of carbon dioxide. The values of RH
c at 25 and 40 degrees C were determined to be between 76 and 88% RH a
nd between 48 and 75% RH, respectively. The accurate moisture content
and the stability profiles of sodium bicarbonate were determined using
a titration-drying-titration procedure. The results of determination
show that sodium bicarbonate powder is stable below 76% RH at 25 degre
es C and below 48% RH at 40 degrees C, respectively. (C) 1998 Elsevier
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