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