Uses: Doxofylline (Doxophylline) is a phosphodiesterase inhibitor, a xanthine derivative, used to treat ... More ...
Uses: Doxofylline (Doxophylline) is a phosphodiesterase inhibitor, a xanthine derivative, used to treat asthma.
Items Standard
Character This product is white needle crystal or
crystalline powder
Melting point 142℃~145℃
Absorption coefficient The absorbance was measured at 273 nm, and
the absorption coefficient (E1cm1% ") should be 335~356
Identification Chemical reaction Infrared identification Should have a positive reaction The infrared light absorption spectrum of
this product should be consistent with the spectrum of the control
Acidity pH value should be 5.8~6.4
Clarification and color of solution The solution shall be clear and colorless;
If it is turbid, it shall not be thicker than No. 1 turbidity standard
solution; If the color is developed, it shall not be
deeper than the yellow No. 1 standard colorimetric solution.
Bromide No thicker (0.055%)
2-bromomethyl-1,3-dioxolane more than 0.0001875%
Related substances The ophylline shall not exceed 0.1% Other single impurities shall not be greater
than 0.10% Other impurities shall not exceed 0.4%
Residual solvent N. The residual amount of
N-dimethylformamide shall not exceed 0.088% Residual ethylene glycol shall not exceed
0.062% Residual methanol shall not exceed 0.3% The residual amount of ethanol shall not
exceed 0.5% The residual amount of dichloromethane
shall not exceed0.06% The residual amount of vinyl acetate shall
not exceed 0.1%
Loss on drying The weight loss shall not exceed 1.0%
Residue on ignition Ignition residue shall not exceed 0.1%
Heavy metal Heavy metals shall not exceed 20 ppm
Microorganism 103cfu/g Total aerobic bacteria
shall not exceed 2x103 cfu/g The total number of molds and yeasts shall
not exceed 102cfu/g Escherichia coli shall not be detected
Bacterial endotoxin It should be less than 0.05EU/mg
Assay Calculated as anhydrous, the content of
C11H14N4O4 should be 98.5% ~ 102.0%