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. 2020 Apr 14;36(4):407–413. doi: 10.1007/s43188-020-00047-0

Table 3.

Results of the estimation of quality of the lyophilized antivenom candidate

Test items Specification Test 1 Test 2 Test 3
Identification Detect precipitation line Pass Pass Pass
Appearance White or lemon yellow powder Pass Pass Pass
Sterility No observed microorganism Pass Pass Pass
Moisture content (water determination) < 3.0% 1.34% 1.38% 1.38%
Uniformity (mass variation test) < 10% 6.1% 6.0% 6.4%
Foreign insoluble particle matter No foreign matter in visual (optical particle counting: over 10 μm ≤ 6000 ea./container) Pass Pass Pass
Leakage P < 3.82 2.86 2.93 2.91