Stability of three batches of the final product evaluated at normal (5°C) at 24 months and accelerated (25°C) conditions at 6 months.
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Potency data are shown in Fig 6. Acceptance criteria for tests specific for identify (detection of 70 kDa (FetA F3-3), Class 1 (P1.16) and Class 3 (P3.15) proteins), pyrogenicity, sterility, appearance (opaque, even, milky) and extractable volume (≥0.50 mL) passed for all 3 batches, and degree of adsorption was >93% for all. Stability of three batches of the final product evaluated at normal (5°C) at 24 months and accelerated (25°C) conditions at 6 months.
创建时间：
2015-09-21
