Assertion: impurity's level | /r/HasProperty | total pool of al
Facets:
Source sentences:
text: Considering the PDE for Al, the maximum allowable level of Al would be 16 μg/mL. Were the total pool of Al measured in the test article to leach into 50-mL of an aqueous drug product, the concentration of Al in such a drug product would be 0.08 μg/mL, which is <1% of the maximum allowable level.