# Commission Implementing Decision of 1 July 2014 authorising the placing on the market of citicoline as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2014) 4252) (Only the German text is authentic) (2014/423/EU), Annex: SPECIFICATION OF CITICOLINE

Extent: E+W+S+N.I.

Definition 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
Description White crystalline powder.
Identification CAS No
987-78-0
pH (sample solution of 1 %)
2,5-3,5
Purity 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 %
Microbiological criteria 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

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Source: https://www.legislation.gov.uk/eudn/2014/423/annex (the official version)
Page: https://openlegislation.uk/eu-decision-2014-423/annex
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.