The homogeneity assessment of each individual lot was made at the time value assignment analyses were performed using CZE, SEC, CE-SDS, FI, and DLS. There was no apparent trend in the data with respect to vial/rack position within a lot or when plotted against the sequence in which the samples were prepared for any of the methods. Furthermore, comparison of each of the initial three lots of RM 8671 demonstrated statistical equivalence in all of the attributes measured. Although each lot of RM 8671 is assigned its own individual reference values, the intra- and inter-lot homogeneity indicates a successful homogenization and vial filling process resulting in consistent content and quality. It is therefore expected that consistent measurement results will be attainable for RM 8671 for the foreseeable future provided the samples are handled upon receipt as directed.