Table 7.
Changes of parameters describing SEC-RID chromatograms (retention time, area, asymmetry factor) of HA (0.4%) solutions after sterilization and during storage under the conditions of the accelerated and long-term tests. Changes to the chromatograms of the unsterilized solution are given in brackets.
| Sterilization Conditions | Fresh Solution | Observed Changes During Storage | |||||||
|---|---|---|---|---|---|---|---|---|---|
| 25 °C/60%RH—6 Months | 40 °C/75%RH—6 Months | ||||||||
| tR, min | P | Af | tR, min | P | Af | tR, min | P | Af | |
| Without sterilization | 6.010 | 560078 | 1.765 | +0.028 | +4.71% | Nc | +0.016 | −4.16% | +0.176 |
| 105 °C/30 min | 5.998 (−0.012) |
565425 (+0.95%) |
1.848 (+0.083) |
+0.003 | +7.56% | +0.327 | +0.081 | −1.27% | +0.024 |
| 121 °C/20 min | 5.997 (−0.013) |
558036 (−0.36%) |
1.793 (+0.028) |
+0.071 | +1.76% | −0.079 | +0.115 | −4.19% | −0.097 |
| 134 °C/12 min | 6.164 (+0.154) |
546165 (−2.48%) |
1.717 (−0.048) |
−0.069 | +1.29% | +0.034 | −0.044 | +1.33% | +0.215 |
Note: tR—retention time; P—area; Af—asymmetry factor; Nc—no change.