Table 4.
Average Complex Particle Size (Z-Average Hydrodynamic Diameters) and Standard Deviation (n = 3) of Diluted (22.3 mM Fe in 0.9% NaCl Solution) and Undiluted (223.8 mM Fe) Brand and Generic SFG Product Samples Measured by Dynamic Light Scatteringa
| drug product | lot no. | Fe conc (mM) | pH | diluent | light scattering geometries | Z-average diameter (nm) | PDI |
|---|---|---|---|---|---|---|---|
| diluted brand SFG | A6122 | 22.3 | 6.8 | 0.9% NaCl | back | 14.8 ± 0.1 | 0.151 |
| A6123 | 22.3 | 6.8 | 0.9% NaCl | back | 15.0 ± 0.0 | 0.169 | |
| A6124 | 22.3 | 6.8 | 0.9% NaCl | back | 14.8 ± 0.4 | 0.178 | |
| undiluted brand SFG | A6122 | 223.8 | 8.5 | NA | back | 26.6 ± 1.1 | 0.218 |
| A6123 | 223.8 | 8.5 | NA | back | 26.0 ± 0.8 | 0.239 | |
| A6124 | 223.8 | 8.5 | NA | back | 25.9 ± 1.4 | 0.252 | |
| A6122 | 223.8 | 8.5 | NA | corner | 24.7 ± 1.0 | 0.044 | |
| diluted generic SFG | 162240.1 | 22.3 | 6.8 | 0.9% NaCl | back | 10.3 ± 0.1 | 0.144 |
| 1702105.1 | 22.3 | 6.8 | 0.9% NaCl | back | 9.8 ± 0.0 | 0.155 | |
| 1702107.1 | 22.3 | 6.8 | 0.9% NaCl | back | 10.3 ± 0.2 | 0.104 | |
| undiluted generic SFG | 162240.1 | 223.8 | 8.0 | NA | back | 17.8 ± 0.5 | 0.337 |
| 1702105.1 | 223.8 | 8.0 | NA | back | 16.7 ± 0.2 | 0.132 | |
| 1702107.1 | 223.8 | 8.0 | NA | back | 16.7 ± 0.1 | 0.16 | |
| 162240.1 | 223.8 | 8.0 | NA | corner | 14.0 ± 1.0 | 0.077 |
a
PDI: polydispersity index.