Skip to main content
. 2007 Jan 24;24(3):605–612. doi: 10.1007/s11095-006-9179-y

Table IV.

Results of the Retrospective Data Analysis: Influence of Production Parameters

  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.