약학회지

ISSN 0377-9556 (PRINT)
ISSN 2383-9457 (ONLINE)
Table. 3. Potency assay results of human immunoglobulin preparations approved in Korea
Samples Kit National lot release results
Kit A Kit B Kit C
Sample 1 Mean (IU/mL) 274 301 259 274
RSD (%) 1.7 5.8 2.1
Sample 2 Mean (IU/mL) 216 221 237 255
RSD (%) 7.8 7.9 2.9
Sample 3 Mean (IU/mL) 221 208 212 288
RSD (%) 6.1 7.3 2.2
Sample 4 Mean (IU/50 mg) 2.99 3.90 2.70 2.74
RSD (%) 2.9 12.1 6.4
Sample 5 Mean (IU/50 mg) 3.10 3.38 2.75 3.38
RSD (%) 4.7 2.8 6.0
Sample 6 Mean (IU/50 mg) 1.52 2.10 1.24 1.12
RSD (%) 4.5 20.6 5.5
Sample 7 Mean (IU/50 mg) 1.22 1.29 0.85 0.99
RSD (%) 8.0 31.9 3.3
Yakhak Hoeji 2024;68:287-93 https://doi.org/10.17480/psk.2024.68.4.287
© 2024 Yakhak Hoeji