Table IV.
Typical Value (%) (%R.S.E) | Batch-to-Batch Variability (%) (%R.S.E) | Vial-to-Vial Variability (%) (%R.S.E) | |
---|---|---|---|
Overall filling process | 99.8 (0.063) | 0.857 (19) | 0.735 (20) |
Product 3 | −0.552a (37) | ||
Product 5 | −0.892a (40) | ||
Product 7 | 0.251b (59) | ||
FILL = 1 ml | 1.99b (49) | ||
VEH = DMSO | +53%a (87) | ||
VEH = TBA/WfI | −33.9%a (75) | ||
Overall content | 100 (0.28) | 4.21 (22) | |
Product 1 | 1.65b (11) | ||
Product 2 | −5.04a (32) | 2.04b (64) | |
Product 3 | 1.95b (28) | 1.51b (21) | |
Product 4 | 2.57b (33) | ||
Product 5 | 1.52b (16) | ||
Product 6 | +7.14a (28) | 2.06b (21) | |
Product 7 | 1.53b (30) | 2.12b (30) |
FILL filling volume, VEH dissolution vehicle, DMSO dimethyl sulfoxide, TBA/WfI 40% v/v tert-butyl alcohol in water for injection, %R.S.E. % relative standard error of estimate.
aRelative difference compared to typical value.
bAbsolute value.