Customization: | Available |
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Function: | Vitamins and Minerals Deficiency Drug, Antibiotic and Antimicrobial Agents |
Certification: | GMP |
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Product Name:
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Levomefolate calcium
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Synonyms:
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(S)-2-(4-((((S)-2-AMino-5-Methyl-4-oxo-3,4,5,6,7,8-hexahydropteridin-6-yl)Methyl)aMino)benzaMido)pentanedioic acid, calciuM salt;
L-5- Methyl leucovorin;Calcium (S)-2-(4-((((S)-2-amino-5-methyl-4-oxo-3,4,5,6,7,8-hexahydropteridin-6-yl)methyl)amino; CALCIUML-5-METHYLTETRAHYDROFOLATE; (6S)-N-[4-(2-Amino-1,4,5,6,7,8,-hexahydro-5-methyl-4-oxo-6-pteridinylmethylamino)benzoyl]-L-glutaminsure, Calciumsalz (1:1); Calcium levomefolate;L-5-Methyltetrahydrofolate calcium;METHYL FOLATE CALCIUM SALT(METAFOLIN)(P) |
CAS:
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151533-22-1
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MF:
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C20H27CaN7O6
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MW:
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501.56
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EINECS:
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691-636-3
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ITEM
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SPECIFICATION
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RESULT
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Test method
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Appearance
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White to light yellow crystalline powder
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Complies
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Visual
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Identification
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IR
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IR should be identical with that of reference
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Complies
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USP43
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Calcium
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A 5-mg/mL solution meets the requirements
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HPLC
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The retention time of the major peak in the chromatograme of Assay preparation corresponds to
that in the chromatograme of the standard preparation, as obtained in the Assay |
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Elemental impuritiys
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Boron
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≤50PPM
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Complies
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USP43
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Platinum
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≤10PPM
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Complies
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Arsenic
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≤1.5PPM
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Complies
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|
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Cadmium
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≤0.5PPM
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Complies
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Lead
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≤1.0PPM
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Complies
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Hg
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≤1.5PPM
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Complies
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Residual solvent
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Ethanol≤0.5% 2-Propanol≤0.5%
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Complies
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USP43
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Related compounds
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4-Aminobenzoylgluta mic acid
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≤0.5%
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ND
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USP43
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4a-Hydroxy-5-methyl-tetrahydrofolic acid
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≤1.0%
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ND
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(6R)-Mefox
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/
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ND
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(6s)-Mefox
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≤1.0%(sum of 6R and 6S)
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0.31%
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Tetrahydrofolic acid
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≤0.5%
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ND
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7,8-Dihydrofolic acid
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≤0.5%
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ND
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Folic acid
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≤0.5%
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ND
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5,10-Methylenetetrah-yd rofolic acid
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≤0.5%
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ND
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5-Methyltetrahydrop-teroic acid
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≤0.5%
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ND
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Dimethyltetrahydrofolic acid
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≤0.15%
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ND
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Total Impurites
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≤2.5%
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1.21%
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D-5-Methylfolate
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≤1.0%
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0.24%
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USP43
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Calcium (on the anhydrous and solvent-free basis)
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7.0%-8.5%
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7.8%
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USP43
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Water determination
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6%-17.0%
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16.3%
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Karl Fischer
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Particle size
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90% pass 80 mesh
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Complies
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Sieve
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Chloride
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≤0.5%
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Complies
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USP43
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Heavy metals
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≤10ppm
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Complies
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USP43
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Total microbacterial count
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≤100CFU/g
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Complies
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CP2015
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Yeast &Mould
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≤10CFU/g
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Complies
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CP2015
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Escherichia Coli presence
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Negative
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Negative
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CP2015
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Salmonella
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Negative
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Negative
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CP2015
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Staphylococcus aureus
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Negative
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Negative
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CP2015
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P. aeruginosa
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Negative
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Negative
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CP2015
|
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Candida albicans
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Negative
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Negative
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CP2015
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Clostridia
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Negative
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Negative
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CP2015
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Calcium L-5-methyltetrahydrofolate
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95.0%-102.0%
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98.9%
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USP43
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L-5-methyltetrahydrofolate
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≥85.0%
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90.1%
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USP43
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Conclusion
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The results conforms with the USP43 standard.
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