18. The data reported in Table 10 seems to show that
the "purity" in terms of a percentage (Time = 0 weeks being 100%)
of Compositions 1 and 2 is essentially the same after 1 and 3
weeks at 50°C and after 3 weeks at 40°C (specification, page 17,
Table 10) (higher percentage set out in bold):
* * 50°C * 40°C *
* * 1 week * 3 weeks * 3 weeks *
* r-hCG/5000/SO1 * 90.0 * 86.3 * 97.2 *
* r-hCG/5000/MO1 * 89.5 * 88.3 * 97.6 *
19. The data reported in Table 11 seems to show that
the "purity" in terms of a percentage (Time = 0 weeks being 100%)
of Compositions 3 and 4 are somewhat better for mannitol vis-a-
vis sucrose in terms of a shelf-life at 50°C, but shelf-life is
slightly better for sucrose vis-a-vis mannitol in terms of a
shelf-life at 40°C. (specification, page 17, Table 11) (higher
percentage set out in bold):
* * 50°C * 40°C *
* * 1 week * 3 weeks * 3 weeks *
* r-hCG/10000/SO1 * 91.8 * 88.9 * 97.9 *
* r-hCG/10000/MO1 * 93.4 * 92.1 * 97.2 *
20. Tables 12 and 13 are said to report the purity
of the "-subunit of r-hCG determined by "reverse phase HPLC"7
Our comments with respect to HPSEC, n.6, supra, also apply to "reverse
phase HPLC".
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