Batch, proposed definition

Testing of a single batch during the development phase and another single definitive pilot scale or larger was proposed as sufficient to establish the photostability of a product, FDA noted its preference for three batches. 

Based on the previous considerations, some authors proposed thermodynamic-based approaches to SAS. De la Fuente Badilla et al attempted to develop a thermodynamic-based criterion for optimum batch antisolvent precipitation (GAS) using a definition of the volume expansion that takes into account the molar volume of the system studied. They analyzed various binary and ternary systems and concluded that the pressure corresponding to a minimum value of the liquid-phase volume expansion coincides with the pressure at which the solute precipitates. In a subsequent work, Shariati and Peters further highlighted the role of SC-CO2 in GAS. It acts as a co-solvent (cosolvency effect) at lower concentrations, whereas at higher concentrations it acts as an antisolvent. 

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