appearance |
white or yellow-white crystalline power |
yellow-white crystalline power |
crystallinity |
meets the requirements |
pass |
identification a |
ir spectrum corresponds to that of the ep reference standard |
confirm |
identificationb |
the principal spot in the chromatogram obtained with the test solution is similar in position and size to that obtained with the reference solution |
confirm |
identificationc |
the aqueous layer is coloured light from reddish- violet to purple. |
confirm |
identification d |
the solution gives reaction (a) of chlorides. |
confirm |
acidity or alkalinity |
not more than 0.1ml. |
confirm |
melting point |
149.0~153.0 °c |
150~151°c |
specific optical rotation |
+18.5 ~ +20.5 |
+19.6 |
chloride |
≤100ppm |
pass |
related substances (tcl) |
≤0.5% |
pass |
loss on drying |
≤0.5% |
0.0% |
sulphated ash |
≤0.1% |
0.04% |
assay (on the dried basis) c11h12cl2n2o5 |
98.0%-~102.0% |
98.9% |