Abstract
Batch-to-batch variation in an active raw material was evaluated following a production process change by the raw material supplier. Physicochemical and physicomechanical tests were applied and indicated that polymorphism or solvate formation was not occurring but changes in crystal properties in terms of size and degree of aggregation were involved. Other more subtle differences in crystal properties were also possibleThe deleterious effect of the raw material process change on tablet production was noted and a method of overcoming the problem identifiedThe necessity for comprehensive? reformulation studies including physicomechanical screening is underlined. Such studies are also necessary if changes in raw material production methods occur to avoid process problems related to the marked hatch-to-batch variation that can occur in these instances
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