Items
EP Specification
Appearance
White to off-white powder, Slightly solution in water, freely solution in acetone, in ethanol, and in methylene chloride.
It shows polymorphism
Identification
Positive
Crystallinity
Meet the requirement
PH
3.5 - 4.0
Water
1.0% max
Specific optical rotation
-17º ~ -21º
Impurity C
4.0% max
Individual impurity
1.0%max
Total impurities
6.0% max
Ethyl acetate residual
500ppm max
Isobutyl acetate residual
5000ppm max
Heptane residual
Acetone residual
Assay
93.0%-100.5%