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Accelerated Stability Studies
Stability study to predict the shelf life of the product, by accelerating the
rate of decomposition, preferably by increasing the temperature of
reaction conditions.
With the advancement in branch of kinetics, shelf life of a dosage form
can be predicted within months based on accelerated stability reports
Preparations are subjected to high stresses during stability testing.
Common high stresses include :
° Temperature
. Humidity
. Light * Extrapolate the straight line to room temperature (k,,) or
refrigerated temperature and read the log k value on y-axis.
* Substitute the k value in the appropriate equation to get the shelf
life of the product. The Preparation is stored at different elevated temperatures, to accelerate
the degradation
Samples are withdrawn at different time intervals
The Order of the reaction is determined by plotting the appropriate
function of concentration against time and linear relationship is
determined
Straight line in a graph permits the estimation of k value from the slope
Similarly graphs are drawn for different elevated temperatures.
K value for each temperature are calculated.
By using Arrhenius relationship, Log k values are plotted against
reciprocal of absolute temperature, energy of activation can be
calculated. 34
“Tr
Arrhenius plot for predicting the rate constant at ambient
temperature(25°C). 2) A solution of a drug contained 500 units/mL when
prepared. It was analyzed after 40 days and was found
to contain 300 units/mL.
Assuming the decomposition is first order, at what
time will the drug have decomposed to one-half of
its original concentration?
Log Ct = Log CO — Kt/ 2.303
Log300 = Log 500 — K x40 days / 2.303
2.477=2.699- K 17.4
K= 0.013 Sec-1
t1/2 = 0.693 /K = 0.693/ 0.011 = 54.25 day Methods for Determining Particle Size
1. Microscopy
2. Sieving
3. Sedimentation techniques
4, Electrical sensing zone method — Coulter Counter
5, Laser Diffraction Method
6. Permeametry Technique
