Table 3.
Specifications for MgCM as proposed by the applicant
| Parameter | Value | Analytical method |
|---|---|---|
| Description | Powder | Visual |
| Assay Mg | 12.0–15.0% | Titration with EDTA (Ph. Eur. 2011) |
| Ratio citrate: malate (peak areas) | 1.28–1.65 | HPLC‐RIa |
| Loss on drying (120°C/4 h) | ≤ 15% | Ph. Eur. 2014 |
Colour
|
|
Visual |
| Clarity of solution (20%, H2O) | Clear | Visual |
| pH (20%) | Approx. 6.0 | Potentiometric |
| Chloride | ≤ 0.05% | British Pharmacopoeia 1973 |
| Sulphate | ≤ 0.05% | British Pharmacopoeia 1973 |
| Heavy metals | ||
| Arsenic | ≤ 3 ppm | Merckoquant® (Merck KGaA, Germany) |
| Lead | ≤ 2 ppm | AASb |
| Cadmium | ≤ 1 ppm | AAS |
| Mercury | ≤ 0.1 ppm | AFSc |
| Microbiology | ||
| Total aerobic count | ≤ 2,000 CFU/g | Ph. Eur. 2014 |
| Yeasts/moulds count | ≤ 200 CFU/g | Ph. Eur. 2014 |
MgCM: magnesium citrate malate; EDTA: ethylenediaminetetraacetic acid; CFU: colony forming unit.
a
High‐performance liquid chromatography with refractive index detection.
b
Atomic absorption spectroscopy.
c
Atomic fluorescence spectroscopy.