Items
Standards
Description
A white or creamy-white powder
Solubility
Slightly soluble in water, freely soluble in 3N hydrochloric acid; slightly soluble in methanol; practically insoluble in alcohol, in acetone, in chloroform, and in ether.
Identification
IR
IR spectrum is consistent with carbidopa CRS
HPLC
Conform with the retention time of the major peak in the chromatogram
Specific rotation
-21.0°~-23.5°
Loss on drying
6.9% ~ 7.9%
Residue on ignition
0.1% max
Heavy metal
0.001% max
-Methyldopa
0.5% max
-Carbidopa related components A
-Any unknown impurity
0.10% max
-Total impurities
1.0%max
Residual solvents
Meet the requirement
Assay
98.0%~102.0%