Annex SPECIFICATION OF (6S)-5-METHYLTETRAHYDROFOLIC ACID, GLUCOSAMINE SALT
United Kingdom
Definition:
| Chemical name | N-[4-[[[(6S)-2-amino-1,4,5,6,7,8-hexahydro-5-methyl-4-oxo-6-pteridinyl]methyl]amino]benzoyl]-L-glutamic acid, glucosamine salt |
| Chemical formula | C32H51N9O16 |
| Molecular weight | 817,80 g/mol (anhydrous) |
Description: Creamy to light-brown powder.
Identification:
| CAS No. | 1181972-37-1 |
Purity:
| Diastereoisomeric purity | At least 99 % of (6S)-5-methyltetrahydrofolic acid |
| F1Glucosamine assay | 34-46 % in dry basis |
| 5-Methyltetrahydrofolic acid assay | 54-59 % in dry basis |
| Water content | Not more than 8,0 % |
| Lead | Not more than 2,0 ppm |
| Cadmium | Not more than 1,0 ppm |
| Mercury | Not more than 0,1 ppm |
| Arsenic | Not more than 2,0 ppm |
| Boron | Not more than 10 ppm |
Microbiological criteria:
| Total aerobic microbial count | Not more than 100 cfu/g |
| Total combined yeast and moulds | Not more than 100 cfu/g |
| Escherichia coli | Absent in 10 g |