TABLE 2.
Batch to batch analysis of the NF.
| Parameters | Method | 2019–1 | 2019–2 | 2019–3 | 2019–4 | 2019–5 | 2010–1 | 2012–1 | 2012–2 | 2012–3 | 2012–4 | 2012–5 | 2012–6 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Appearance | Visual | White powder | White powder | White powder | White powder | White powder | White powder | NA | NA | NA | NA | NA | NA |
| Odour and taste | Organoleptic | Conf. | Conf. | Conf. | Conf. | Conf. | NA | NA | NA | NA | NA | NA | NA |
| Solubility | Visual (1% at 25°C) | Conf. | Conf. | Conf. | Conf. | Conf. | Conf. | NA | NA | NA | NA | NA | NA |
| Colour of solution | Visual (1% solution) | Conf. | Conf. | Conf. | Conf. | Conf. | NA | NA | NA | NA | NA | NA | NA |
| Bulk density | Loose fill in graduated cylinder | 0.68 g/mL | 0.72 g/mL | 0.77 g/mL | 0.67 g/mL | 0.68 g/mL | NA | NA | NA | NA | NA | NA | NA |
| Particle size NLT 90% thru a US # 20 (0.841 mm) |
Ro Tap Sieve shaker (3 min) |
100.0 | 100.0 | 100.0 | 100.0 | 100.0 | NA | NA | NA | NA | NA | NA | NA |
| NMT 60% thru a US # 200 (0.074 mm) | Ro Tap (3 min) | 25 | 31 | 30 | 30 | 32 | NA | NA | NA | NA | NA | NA | NA |
| Identification | IR | Conf. | Conf. | Conf. | Conf. | Conf. | Conf. | NA | NA | NA | NA | NA | NA |
| Loss on drying (%) | 105°C, 4 h | 0.4 | 0.3 | 0.2 | 0.3 | 0.1 | Conf. | NA | NA | NA | NA | NA | NA |
| Mg l‐threonate monohydrate (%) | Titration | 100.6 | 100.5 | 100.7 | 100.6 | 100.5 | Conf. | NA | NA | NA | NA | NA | NA |
| Magnesium (%) | ICP‐OES | 7.7 | 7.7 | 7.7 | 7.7 | 7.7 | 7.6 | 7.6 | 7.5 | 7.7 | 7.7 | 7.8 | 7.8 |
| l‐threonate (%) | HPLC | NA | NA | NA | NA | NA | 87.4 | 88.8 | 88.8 | 89.1 | 88.2 | 87.7 | 86.3 |
| Ethanol (ppm) | USP 467 (GC) | 136 | 138 | 148 | 147 | 131 | NA | NA | NA | NA | NA | NA | NA |
| pH | USP (1% in H2O) | 6.3 | 6.4 | 6.4 | 6.4 | 6.4 | NA | NA | NA | NA | NA | NA | NA |
| Arsenic (ppm) | ICP‐MS | 0.011 | 0.014 | 0.012 | 0.038 | 0.019 | < 0.2 | 0.370 | 0.779 | 0.494 | 0.508 | 0.365 | 0.745 |
| Mercury (ppm) | ICP‐MS | 0.002 | 0.007 | 0.006 | 0.001 | 0.033 | < 0.05 | < 0.001 | 0.021 | 0.004 | 0.002 | < 0.001 | < 0.001 |
| Lead (ppm) | ICP‐MS | 0.042 | 0.044 | 0.030 | 0.036 | 0.028 | < 0.05 | 0.057 | 0.208 | 0.087 | 0.151 | 0.069 | 0.083 |
| Cadmium (ppm) | ICP‐MS | 0.005 | 0.004 | 0.008 | 0.003 | < 0.001 | < 0.05 | 0.001 | 0.001 | 0.002 | 0.005 | 0.002 | 0.003 |
| Total plate count (cfu/g) | USP <2021> | 10 | 10 | 10 | < 10 | 10 | < 3000 | ≤ 10 | ≤ 10 | 75 | ≤ 10 | ≤ 10 | ≤ 10 |
| Yeast and mould (cfu/g) | USP <2021> | < 10 | < 10 | < 10 | < 10 | < 10 | < 300 | ≤ 10 | ≤ 10 | ≤ 10 | ≤ 10 | ≤ 10 | ≤ 10 |
| E. coli | USP <2022> | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg |
| Salmonella | USP <2022> | Neg | Neg | Neg | Neg | Neg | NA | Neg | Neg | Neg | Neg | Neg | Neg |
Abbreviations: Cfu, colony forming unit; conf., conforms; GC, gas chromatography; ICP‐OES, Inductively coupled plasma–optical emission spectrometry; ICP‐MS, inductively coupled plasma mass spectrometry; IR, infrared; NA, not available; Neg, negative; NLT, not larger than; USP, United States Pharmacopeia.