item standard test results
a.h-nmr:comply with the structure complies
b.lc-ms:comply with the structure complies
c.the ir spectrum of sample should be identical complies
with that of reference standard;
identification d.hplc-esi-ms
the retention time of the major peak in the chromatogram of the complies
assay preparation corresponds to that in the chromatogram of the
standard preparation, as obtained in the assay.
crystallinity meets the requirements complies
loss on drying ≤2.0% 0.19%
heavy metals ≤10 ppm <10ppm
water ≤1.0% 0.1%
sulphated ash ≤0.5%, determined on 1.0 g. 0.009%
related unspecified impurities: for each impurity ≤0.10% <0.10%
substances total impurity ≤0.5% 0.18%
purity ≥99.0% 99.7%
assay 99.0%~101.0% (anhydrous substance). 99.8%
microbiological analysis
total plate count ≤1000cfu/g complies
yeast and moulds ≤100cfu/g complies
e. coli. absent negative
salmonella absent negative
s.aureus absent negative
storage preserve in well-closed, light-resistant and airtight containers. complies