Calcium Folinate

Calcium Folinate BP Grade
Ph Eur
C20H21CaN7O7,xH2O --- 511.5 --- 1492-18-8
Action and use: Antidote to folic acid antagonists.

DEFINITION
Calcium (2S)-2-[[4-[[[(6RS)-2-amino-5-formyl-4-oxo1,4,5,6,7,8-hexahydropteridin-6-yl]methyl]amino]benzoyl]amino]pentanedioate.
Content:
calcium folinate (C20H21CaN7O7): 97.0 per cent to 102.0 per cent (anhydrous substance);
calcium (Ca; A r 40.08): 7.54 per cent to 8.14 per cent (anhydrous substance). It contains a variable amount of water.

CHARACTERS
Appearance: White or light yellow, amorphous or crystalline powder.
Solubility: Sparingly soluble in water, practically insoluble in acetone and in ethanol (96 per cent). The amorphous form may produce supersaturated solutions in water.

IDENTIFICATION
First identificationı A, B, D.
Second identificationı A, C, D.
A. Specific optical rotation.
B. Infrared absorption spectrophotometry.
C. Thin-layer chromatography.
D. It gives reaction of calcium.
Carry out the tests and the assay as rapidly as possible, protected from actinic light.

TESTS
Solution S: Dissolve 1.25 g in carbon dioxide-free water, heating at 40C if necessary, and dilute to 50.0 ml with the same solvent.
Appearance of solution: Solution S is clear and its absorbance at 420 nm is not greater than 0.60.
pH: 6.8 to 8.0 for solution S.
Specific optical rotation: + 14.4 to + 18.0 (anhydrous substance), determined on solution S.
Acetone, ethanol and methanol Limits:
acetone : maximum 0.5 per cent;
ethanol : maximum 3.0 per cent;
methanol : maximum 0.5 per cent.
Related substances: To pass the test,
Chlorides: Maximum 0.5 per cent.
Heavy metals: Maximum 50 ppm.
Platinum: Maximum 20.0 ppm.
Water: Maximum 17.0 per cent, determined on 0.200 g (ground to a very fine powder ).
Bacterial endotoxins: Less than 0.5 IU/mg, if intended for use in the manufacture of parenteral dosage forms without a further appropriate procedure for the removal of bacterial endotoxins.

STORAGE
In an airtight container, protected from light. If the substance is sterile, store in a sterile, airtight, tamper-proof container .

IMPURITIES
Specified impurities A, B, C, D, E, F, G:
A. (2S)-2[(4-aminobenzoyl)amino]pentanedioic acid
B. (2S)-2-[[4-[[[(6RS)-2-amino-5-formyl-4-oxo-1,4,5,6,7,8-hexahydropteridin-6-yl]methyl]formylamino]benzoyl]amino]pentanedioic acid (5,10-diformyltetrahydrofolic acid)
C. folic acid
D. (2S)-2-[[4-[[(2-amino-4-oxo-1,4-dihydropteridin-6-yl)methyl]formylamino]benzoyl]amino]pentanedioic acid (10-formylfolic acid)
E. 4-[[[(6RS)-2-amino-5-formyl-4-oxo-1,4,5,6,7,8-hexahydropteridin-6-yl]methyl]amino]benzoic acid (5-formyltetrahydropteroic acid)
F. R = CHO: (2S)-2-[[4-[[(2-amino-4-oxo-1,4,7,8-tetrahydropteridin-6-yl)methyl]formylamino]benzoyl]amino]pentanedioic acid (10-formyldihydrofolic acid)
G. R = H: (2S)-2-[[4-[[(2-amino-4-oxo-1,4,7,8-tetrahydropteridin-6-yl)methyl]amino]benzoyl]amino]pentanedioic acid (dihydrofolic acid).

Certifications :
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