Identification
A.H-NMR:Comply with the structure
B.LC-MS:Comply with the structure
C.The IR spectrum of sample should be identical with that of reference standard;
D.HPLC-ESI-MS: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Loss on drying: ≤2.0%
Heavy metals: ≤10 ppm
Water: ≤1.0%
Sulphated ash: ≤0.5%, determined on 1.0 g.
Related substances
Unspecified impurities: for each impurity ≤0.10%
Total Impurity: ≤0.5%
Purity: ≥99.0%
Assay: 99.0%~101.0% (anhydrous substance).
Microbiological Analysis
Total plate count: ≤1000cfu/g
Yeast and Moulds: ≤100cfu/g
E. Coli.: Absent
Salmonella: Absent
S.aureus: Absent
