Classification of the Different Analytical Results with Regards to the Criticality for 24 Weeks at 40 °C
| Classification | Citrate Buffer, pH 6.0 | Phosphate Buffer, pH 7.0 | Sodium Bicarbonate | |||
|---|---|---|---|---|---|---|
| Standard | Controlled | Standard | Controlled | Standard | Controlled | |
| Delamination confirmed | No | No | YES | No | No | No |
| Early indicators for delamination | No | No | YES | YES | YES | No |
| Glass attack | YES | YES | YES | YES | YES | YES |