Table 1.

In vitro stability of rFVIIa-RT after reconstitution with correct volumes of inappropriate solvents (sterile water for injection or saline) and the appropriate histidine solvent46

Storage time (h)	Storage temperature (°C/°F)	Concentration (mg/mL)	Dimer/oligomer formation (%)	Polymer formationa (%)	Heavy chain degradation (%)	Oxidized forms (%)	pH
rFVIIa-RT 1 mg reconstituted with 1.15 mL recommended solvent (histidine)
0	–	0.97	1.4	<0.3	8.5	1.2	6.1
6	25/77	0.99	1.3	<0.3	8.6	1.2	6.1
rFVIIa-RT 1 mg reconstituted with 1.15 mL sterile water
0	25/77	0.96	1.5	<0.3	8.8	1.2	6.0
6	25/77	0.95	1.3	<0.3	8.7	1.2	6.0
rFVIIa-RT 1 mg reconstituted with 1.15 mL physiologic saline
0	25/77	0.97	1.5	<0.3	8.7	1.2	6.0
6	25/77	0.98	1.5	<0.3	8.6	1.2	6.0

Note:

^aThe limit of quantification of the analysis was 0.3%. This article was published in Clinical Therapeutics, Petersson et al.46 Copyright © 2008, Elsevier.

Abbreviation: rFVIIa-RT, room temperature stable activated recombinant factor VII.