Table 3.
Specification for DMM as proposed by the applicant
| Specification parameter | Specification value | Method of analysis |
|---|---|---|
| Technical characteristics | ||
| Description | White to off‐white powder | Visual inspection |
| Identification | Passes test | FTIR analysis |
| Assay | ||
| Magnesium content | Not less than 20% | ICP‐AES |
| Malic acid content | Not less than 52% | HPLC |
| pH value | 10–11 | pH meter |
| Moisture/Loss on drying | Not more than 12% | Moisture balance |
| Fumaric acid content | Not more than 1.0% | HPLC |
| Maleic acid | Not more than 0.05% | HPLC |
| Heavy metals | ||
| Arsenic | Not more than 3.0 ppm | ICP‐MS |
| Lead | Not more than 1.5 ppm | ICP‐MS |
| Cadmium | Not more than 0.5 ppm | ICP‐MS |
| Mercury | Not more than 0.1 ppm | ICP‐MS |
| Microbiological specifications | ||
| Total plate count | Not more than 1,000 | FDA BAM 8th edition |
| Yeast and moulds | Not more than 100 | AOAC 995.21 |
| Coliform count | Negative | FDA BAM 8th edition |
| Escherichia coli | Negative | FDA BAM 8th edition |
| Staphylococcus aureus | Negative | FDA BAM 8th edition |
| Salmonella | Negative | AOAC 991.12 |
FTIR: Fourier‐transforming infrared; HPLC: high‐performance liquid chromatography; ICP‐MS: inductively coupled plasma mass spectrometry; BAM: bacteriological analytical manual; nd: not detectable information available.