Table 3.
Analysis of three batches of the NF
| Batch analysis results | ||||
|---|---|---|---|---|
| Parameter | Specification | Lot number 902310 | Lot number 902870 | Lot number 903023 |
| Appearance | Powder | Conforms | Conforms | Conforms |
| Colour | Off‐white | Conforms | Conforms | Conforms |
| Particle size | Monitor | Not reported | Not reported | Not reported |
| Loss on drying | NMT 10% | 5 | 5 | 4 |
| Identification | ||||
| Test A (absence of konjac glucomannan) | Conforms | Conforms | Conforms | Conforms |
| Test B (absence of sodium alginate) | Conforms | Conforms | Conforms | Conforms |
| Test C (absence of xanthan gum) | Conforms | Conforms | Conforms | Conforms |
| Test D (viscometric characterisation) | Conforms | Conforms | Conforms | Conforms |
| Viscosity over time | ||||
| 10 min | 800–10,900 cP | 3,500 | 8,000 | 8,400 |
| 60 min | 16,400–42,200 cP | 20,700 | 41,900 | 41,400 |
| 120 min | 22,700–45,000 cP | 27,500 | 42,300 | 43,200 |
| Contaminants | ||||
| Lead | NMT 0.6 ppm | 0.5 | 0.5 | 0.4 |
| Mercury | NMT 0.1 ppm | < 0.1 | < 0.1 | < 0.1 |
| Cadmium | NMT 0.4 ppm | 0.1 | 0.08 | 0.07 |
| Arsenic | NMT 0.6 ppm | 0.3 | 0.3 | 0.5 |
| Pesticide residue | Meets USP limits | Conforms | Conforms | Conforms |
| Residual solvent: ethanol | NMT 5,000 ppm | Not detected | 236 | 311 |
| Microbiological parameters | ||||
| Standard plate count | NMT 3000 CFU/g | 1,100 | 300 | 100 |
| Yeast and mould | NMT 300 CFU/g | < 20; 20 | < 20; < 20 | < 20; < 20 |
| Escherichia coli | Negative | Negative | Negative | Negative |
| Salmonella spp. | Negative | Negative | Negative | Negative |
| Staphylococcus aureus | Negative | Negative | Negative | Negative |
| Pseudomonas aeruginosa | Negative | Negative | Negative | Negative |
CFU: colony forming units; cP: centipoise; ppm: parts per million; NMT: not more than.