Cocarboxylase tetrahydrate, EMPROVE® API, SAFC®
Leverantör: MERCK PRODUCTION CHEMICALS
Synonyms:
2-(3-((4-Amino-2-methylpyrimidin-5-yl)methyl)-4-methylthiazol-3-ium-5-yl)ethyl dihydrogen diphosphate tetrahydrate, Thiamine diphosphoric acid ester tetrahydrate
5.00111.5000
5.00111.0100
5.00111.5000EA
0
SEK
5.00111.5000
5.00111.0100
Cocarboxylase tetrahydrate, EMPROVE® API, SAFC®
Cocarboxylase tetrahydrate
Formel:
C₁₂H₁₈N₄O₇P₂S·4H₂O MW: 496,37 g/mol Storage Temperature: Omgivande |
MDL Number:
MFCD00150680 CAS nummer: 68684-55-9 EINECS: 205-230-7 |
Specifikation testresultat
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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