items |
specification |
||
characters |
white or yellowish amorphous powder , hygroscopic. |
||
identification |
a. hplc |
the principal peak in the chromatogram obtained with the test solution is similar in retention time and size to the principal peak in the chromatogram obtained with reference solution. |
|
b. ir |
consistent with reference standard |
||
specific optical rotation |
+168°~+183° (anhydrous substance) |
||
water |
≤4.0% |
||
ph |
5.5~7.5 |
||
absorbance |
≤0.15. nmt 0.15 at 425nm. |
||
sulphated ash |
≤0.2% |
||
heavy metals |
≤20ppm |
||
related substances |
total impurity |
≤3.0% |
|
any impurity |
≤0.2% |
||
impurity a |
≤0.6% |
||
impurity b |
≤0.5% |
||
impurity c |
≤1.5% |
||
impurity d |
≤1.0% |
||
impurity e |
≤0.2% |
||
impurity f |
≤0.3% |
||
impurity g |
≤0.3% |
||
impurity h |
≤0.2% |
||
assay (anhydrous substance) |
96.0%~102.0% |
||
microbiological purity |
not more than 1000 aerobic bacteria per 1 g |
||
not more than 100 fungi per 1 g |
|||
absence of escherichia coli per 1 g |
|||
conclusion |
conform to the eu specification |
||