|
Items |
Specification |
Results |
|
Desciption |
White or almost white crystalline powder |
Conforms |
|
Solubility |
Slightly soluble in water,hardly soluble in ethanol,does not dissolve in olis and fats,soluble in dilute acid , dilute alkali |
Conforms |
|
Identification |
IR : the IR spectrum of sample should be concordant with the spectrum of working standard |
Conforms |
|
TLC: the principal spot in the chromatogram obtained with the test solution should be similar in position,colour to the principal spot in the chromatogram obtained with reference solution. |
Conforms |
|
Chemical test:should develop dark yellow colour |
Conforms |
Appearance of solution
(in HCl/NH4OH) |
Not more opalescent than reference suspension Ⅱ |
Conforms |
|
PH |
3.5-5.5 |
5.1 |
|
Specific optical rotation |
+290°~+315° |
+305° |
|
Water |
11.5%-14.5% |
13.3% |
|
Assay（anhydrous） |
95.0-102.0% |
100.0% |
|
Related substances |
Any impurity :≤1.0% |
0.1% |
|
Related solvents |
N,N-Dimethylaniline:≤20ppm
Acetone:≤0.5%
methanol: ≤0.3% |
----(not used in process)
----
0.01% |
|
Sulfated ash |
≤1.0% |
0.035% |
