Table 7 Comparison of dalbavancin degradation products in different formulations at 70 °C and 40 °C
AcB10 | AcB10Ca10 | AcB10Mg2 | AcB10Zn2 | AcB10Cyclod55 | AcB10Ca10Cyclod55 | Phosp10 | Phosp10Cyclod110 | Phosp10Mg50Cyclod110 | |
|---|---|---|---|---|---|---|---|---|---|
70 °C study | |||||||||
MAG | 51.2 | 53.6 | 50.5 | 49 | 40.1 | 34.9 | 11.1 | 7.4 | 15.2 |
DB-R2 | 0.74 | 6.6 | 1.7 | ||||||
DB-R6 | |||||||||
DB-Iso-DP1 | 0.97 | 0.71 | 0.92 | 0.61 | 1.4 | 1.7 | 1.9 | 2.4 | 2.4 |
DB-DP1 | 0.77 | 0.62 | 0.76 | 0.62 | 0.23 | 0.34 | 0.82 | 0.9 | 0.7 |
DB-Iso-DP2 | 1.6 | 1.2 | 1.6 | 1.1 | 2.1 | 3.3 | 7.2 | 14.2 | 9.3 |
DB-DP2 | 1.1 | 0.9 | 1.1 | 0.76 | 0.26 | 0.4 | 1.8 | 3.3 | 2 |
Unknown | 4.9 | 4.3 | 5.1 | 2.5 | 5 | 5.3 | 7 | 16.9 | 5.6 |
Dalbavancina | 39.5 | 38.7 | 39.9 | 42.1 | 50.9 | 54 | 64.1 | 45.9 | 60.2 |
All degradants | 60.5 | 61.3 | 60.0 | 54.6 | 49.1 | 46.0 | 30.6 | 51.7 | 36.9 |
40 °C study | |||||||||
MAG | 41.8 | 40.3 | 42 | 42.3 | 24 | 24.3 | 3.9 | 6.1 | |
DB-R2 | 0.23 | 0.24 | 6.5 | 3.0 | |||||
DB-R6 | 0.68 | 0.25 | 0.23 | 0.85 | 0.47 | ||||
DB-Iso-DP1 | |||||||||
DB-DP1 | |||||||||
DB-Iso-DP2 | 0.61 | 0.77 | 0.62 | 0.59 | 0.96 | 0.85 | 4.1 | 3.2 | |
DB-DP2 | |||||||||
Unknown | 0.55 | ||||||||
Dalbavancin | 48 | 51 | 49 | 49 | 71 | 71 | 50 | 66 | |
All degradants | 43.3 | 41.1 | 42.6 | 43.1 | 25.2 | 25.4 | 15.9 | 12.8 | |