Stability with respect to physicochemical attributes was evaluated based on extended thaw/freeze testing and storage at various temperatures. In all cases, except for particle generation with multiple T/F cycles, the ability of the material to withstand several T/F cycles and extended storage at 4 °C (as indicated in Table S17 and Table S18 in the ESM) provides users a variety of options to suit their individual testing needs. Optimal storage for extended periods is in a frozen state at −80 °C. Prior to analysis, the vial should be removed from the −80 °C freezer and thawed at room temperature for approximately 30 min or until no residual ice crystals remain. Once thawed, the vial should be gently inverted five times to alleviate any concentration gradients that may have formed during the freezing process. The vial should then be briefly spun in a mini-centrifuge to settle any solution that may otherwise remain adhered to the lid or internal threads of the vial. When handled according to the optimum storage conditions, RM 8671 is expected to result in physicochemical performance within the assigned control range (ESM Table S17) for each qualified physicochemical reference value method described previously in this series [11, 12].