Table 5.
Effect of excipients on fluorescent properties and antigenicity after exposure to Moisture (37 °C and 80% RH for 30 days)
Fluorescence properties | ||||
---|---|---|---|---|
Excipients | Soluble protein (%) | λmax | I350/I329 | Antigenicity (%) |
TT standard | 329 | 0.75 | 100 | |
Lyophilized TT standard | 327 | 0.73 | 100 | |
None | 15 ± 1 (15 d) | * | * | * |
Histidine | 101 ± 5 | 329 | 0.72 | 24 |
Lysine | 103 ± 1 | 329 | 0.76 | 81 ± 12 |
Trehalose | 92 ± 4 | 328 | 0.73 | 47 |
Sorbitol | 87 ± 1 | 329 | 0.75 | 90 ± 8 |
Monomers (pH 2.9) | Aggregates formed before incubation | * | * | * |
MgCO3/monomers pH 5.7 | 9 ± 1 | * | * | * |
MgCO3/monomers pH 8 | 4 ± 2 | * | * | * |
Not determined