introduction incompatibility definition 3 types objective of the study why to screen excipients 1 need to minimize no of model formulations 2 provide rational basis for selecting excipients 3 formulation ...
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...Introduction incompatibility definition types objective of the study why to screen excipients need minimize no model formulations provide rational basis for selecting formulation stability studies are time consuming goal identify that compatible with api do not have impact on importance stabity can be maximised helps avoid surprise problems essential ind submission bridges drug discovery and development compatibility tests aspects identification a stable storage conditions solid state reactions much slower difficult interpret liquid easier detect acc guidelines by fda following should evaluated solutions or suspensions acidic alkaline ph presence added substances high oxygen nitrogen atmospheres effect stress testing steps in there three consider sample preparation method analysis samplea mixture excipient sampleb moisture samplec itself without o all samples blends kept weeks at specified then is physically observed it assayed tlc hplc dsc whenever feasible degradation product identif...