VITEK MS Collaborative Study Outline - eBook
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T = 0 day T = 21 days T = 62 days T = 119 days T = 126 days T = 242 days T = 370 days T = 410 days (Tc) after (T = 2 (T = 4 (T = 8 (T = 12 (T = 13.2 Lot 1: I229/10 Pass a Pass Pass Pass Pass Pass Pass Pass Lot 3: I231/10 Pass Pass Pass Pass Pass Pass Pass Pass a The correct ID result was obtained under each test condition in the stability study, thus meeting the acceptance criteria to establish shelf‐life claim. Lot 2: I230/10 Pass Pass Pass Pass Pass Pass Pass Pass thermal shock months) months) (T = 4 months + 1 week) months) months) months)
Table 22. Lot to lot/Stability Study Results
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