| Key structural differences* | IC Manufacturer | ||||
|---|---|---|---|---|---|
| Shanghai CP Guojian | Lafrancol | Cipla | Probiomed | AryoGen | |
| Identity (tryptic peptide map HPLC): Atypical | Y | ||||
| Aggregation (SE HPLC): above specification limit | Y | Y | Y | ||
| Charged species (IEF/AEX chromatography): Differences in distribution vs ETN | Y | Y | Y | Y | |
| Purity (HIC): Atypical profile | Y | Y | Y | ||
| Carbohydrate profile (N-linked oligosaccharide map): Atypical (additional species not in ETN profile) | Y | Y | |||
*Relative to ETN release specifications and additional characterization historical data. Y, yes.