TABLE IV

Concentration and Log P of Each Oligomer in the Lyophilized Drug Product, the Reconstituted Drug Product Solution, Potassium Chloride, and Activated Charcoal at the Final Time Point. Mean (x̄) and standard deviation (σ) values were obtained from three replicate preparations. <QL (quantification limit): Compound was detected, but the response was below the method quantification limit of 0.04 μg/g for the lyophilized drug product, 0.002 μg/mL for the reconstituted drug product, and 0.1 μg/g for potassium chloride and activated charcoal. Log P values preceded by < indicate equilibrium was not achieved and thus final value may be less than reported. Log P values preceded by ≥ indicate value was less than the QL, and thus the QL concentration was used to approximate the value which may be greater than that reported. ND: Not detected; NA: Not applicable; -: No quantitative data available for calculation of Log P.