Table 3.
Sodium linolenyl hyaluronate and its specification; the table provides the identity of each batch, acceptance criteria, and analytical methods used for the test (Huerta-Angeles et al., 2016b).
| Test | Specification limit value | Value | Methoda |
|---|---|---|---|
| Appearance | Visual | White or yellow granules | EP |
| Appearance of the solution (A600) | Clear | – | EP 2.2.2.5 |
| Average molecular weight Mw1 | 10−30 | kDa | EP method |
| Identification of sample (name, batch, structure) | Name and Number of batch | Pass | USP |
| Degree of substitution | 7–13 | % | NMR |
| Intrinsic viscosity | ≥0.65 m3/Kg | Absolute value | EP 5.1472 |
| Dry matter | >85 | % | USP/EP |
| Loss of drying | <10 | % | USP/EP |
| IPA | <0.5 | % | Residual solvents, EP, pass |
| TEA | <0.03 | % | Residual solvents, EP, pass |
| DMAP | <0.03 | % | Residual solvents, EP, pass |
| Free linolenic acid (FLA) | <0.5 | % | Residual chemicals, EP pass |
| Bacterial endotoxins | <100 | CFU/g | EP 2.6.14 |
| Heavy metals | <20 | ppm | EP 2.4.8 |
| pH of solution (0.5% in water) | 5.0–8.5 | – | EP 2.2.3 |
a
EP stands for European pharmacopeia and the number described the method of limits and analytical determination, USP stands for United states pharmacopeia.