Annex SPECIFICATION OF CITICOLINE
United Kingdom
Definition Description Identification
Purity
Microbiological criteria
Citicoline is composed of cytosine, ribose, pyrophosphate and choline.
Chemical name: Choline cytidine 5′-pyrophosphate, Cytidine 5′-(trihydrogen diphosphate) P′-[2-(trimethylammonio)ethyl]ester inner salt
Chemical formula: C14H26N4O11P2
Molecular weight: 488,32 g/mol
White crystalline powder.
| CAS No | 987-78-0 |
| pH (sample solution of 1 %) | 2,5-3,5 |
| Assay value | Not less than 98 % of dry matter |
| Loss on drying (100 °C for 4 hours) | Not more than 5,0 % |
| Ammonium | Not more than 0,05 % |
| Total heavy metals (as Pb) | Not more than 10 ppm |
| Arsenic | Not more than 2 ppm |
| Free phosphoric acids | Not more than 0,1 % |
| 5′-Cytidylic acid | Not more than 1,0 % |
| Total plate count | Not more than 1 000 cfu/g |
| Yeast and moulds | Not more than 100 cfu/g |
| Escherichia coli | Absent in 1 g |