СITICOLINE SODIUM

Quality
No. Requirements Methods
characteristics
Appearance Crystalline powder of white or almost white color. Visual
1. Hygroscopic.

2. Solubility Easily soluble in water P, practically insoluble in ethanol 1.4

(96 per cent) P, acetone P and methylene chloride P
3. Identification A. Infrared absorption spectrophotometry. 2.2.24

B. On the chromatogram of the tested solution, the 2.2.29

retention time of the main peak should correspond to the
retention time of the main peak on the chromatogram of
the comparison solution.

C. It gives the reaction (а) of sodium 2.3.1

4. Clarity of Solution S is clear 2.2.1
solution

5. Color of the Solution S is colourless 2.2.2,

solution method II
6. pH 6.0 - 7.5 2.2.3
7. Related cytidine 5-monophosphate – not more than 0.2 % 2.2.29
substances uridine diphosphate choline – not more than 0.1 %
cytidine, uridine – not more than 0.2 %
non-specific impurities – not more than 0.10 %
total impurities – not more than 0.5 %
8. Residual solvents Ethanol not more than 0.5 % (5000 ppm) 2.2.28

9. Chlorides Not more than 500 ppm 2.4.4

10. Ammonium Not more than 500 ppm 2.4.1 method A

11. Iron Not more than 100 ppm 2.4.9

12. Phosphates Not more than 0.1 % 2.4.11

13. Loss on drying Not more than 5.0 % 2.2.32

14. Heavy metals Not more than 10 ppm 2.4.8, method

А
15. Arsenic Not more than 1 ppm Ph Eur 2.4.2
method А
16. Assay Not less than 98.0 % C34H25N4NaO11P2 (dried substance) 2.2.29
-102.0 %

17. Bacterial Not more than 0.3 IU/mg 2.6.14

endotoxins
18. Microbiological TAMC – not more than 102 cfu/g 2.6.12
purity TYMC – not more than 10 cfu/g