Cocarboxylase tetrahydrate, EMPROVE® API, SAFC®
:68684-55-9
:
:C₁₂H₁₈N₄O₇P₂S·4H₂O
:MFCD00150680
:496.37 g/mol
:Ambient
:205-230-7
- Assay (HPLC, calc.on anhydrous substance):96.0 - 101.0 %
- Identity (IR-spectrum):passes test
- pH-value (10 %; water):2.4 - 3.2
- Chloride (Cl) (Ion Chromatography):≤ 0.025 %
- Free phosphate (PO₄):≤ 1.0 %
- Al (Aluminium) (#):≤ 0.0010 %
- As (Arsenic):≤ 0.0003 %
- Ni (Nickel) (#):≤ 0.0002 %
- Thiamine phosphoric acid ester (HPLC):≤ 1.5 %
- Thiamin (HPLC):≤ 0.1 %
- Dithiamintriphosphate (HPLC):≤ 0.25 %
- Impurity A (HPLC):≤ 0.1
- Impurity B (HPLC):≤ 0.1
- Related substances (HPLC):≤ 1.5 %
- Water:14.0 - 16.5 %
- Endotoxins:< 12
- Residual Solvents of class 3 ((2-Propanol) according to ICH Q3C):≤ 0.2 %
- Other residual solvents (according to ICH Q3C):excluded by manufacturing process
- Microbiological test:passes test
- Colony count (aerobic bacteria (TAMC)):≤ 1000 CFU/g
- Colony count (Yeasts and moulds (TYMC)):≤ 100 CFU/g
- E.coli:passes test
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