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This document provides batch-specific testing results including HPLC purity analysis showing greater than 98% purity, mass spectrometry confirming the correct molecular weight of 1419 daltons, and endotoxin testing below safe thresholds

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The terminal half-life was 2.8 hours in subjects with normal renal function, 4.0 hours in mild renal impairment, 6.6 hours in moderate renal impairment and 8.7 hours in severe renal impairment