Table 4 Summary of stability studies for VEN in QC samples
Batch | Theoretical concentration (ng/mL) | |||
|---|---|---|---|---|
Rat | Dog | |||
3 | 800 | 3 | 800 | |
(A) Short-term stability at room temperature (22 °C, 22 h for rats, 24 h for dogs, n = 6) | ||||
Mean estimated concentration | 2.62 | 725 | 3.15 | 688 |
RE (%)1 | − 12.7 | − 9.4 | 5.0 | − 14.0 |
CV (%)2 | 5.7 | 5.6 | 7.5 | 3.3 |
(B) Freeze–thaw stability (3 cycles for rats, 4 cycles for dogs, n = 6) | ||||
Mean estimated concentration | 2.59 | 710 | 2.90 | 735 |
RE (%) | − 13.7 | − 11.3 | − 3.5 | − 8.1 |
CV (%) | 5.9 | 7.6 | 8.1 | 2.9 |
(C) Long-term stability (107 days for rats, 87 days for dogs, n = 6) | ||||
Mean estimated concentration | 3.42 | 907 | 29.7 | 693 |
RE (%) | 14.0 | 13.4 | − 1.0 | − 13.4 |
CV (%) | 12.1 | 5.0 | 4.4 | 4.0 |
(D) Processed sample stability (at 10 °C for 8 days, n = 3) | ||||
Mean estimated concentration | 3.00 | 773 | 3.08 | 785 |
RE (%) | 0.0 | − 3.4 | 2.7 | − 1.9 |
CV (%) | 2.4 | 4.1 | 0.7 | 1.4 |