Statistical Techniques.

There is a standard procedure available to use statistics in determining the validity of Arrhenius treatment of data.Statistical aspecys as per Cartenson and Su when the decomposition is less than 10% which is the case for many drugs of intermediate stsbility and for those new Drug Application s being considered. Zero order and First order degradations and practically indistinguishable.

Rate constants of degradation ofDiazepam Injection,

t 'o C 1000/T 105 K1(hrS-1) y=S+log K1
However. if all the data in the above format are employed.Then
logK 25'oC=[0.2257-7] + or - 0.2937
which corresponds to,
K25'0C of 8.51x10'-8 to3.30x10'-7

The interval is much narrower, and at the higher rate constant, the drug remaining after two years would be calculated to be 98.7%