Identification

B.LC-MS:Comply with the structure

Complies

C.The IR spectrum of sample should be identical with that of reference standard;

Complies

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.

Complies

Crystallinity

Loss on drying

Heavy metals

Water

Sulphated ash

Related substances

<0.10%

Total Impurity

0.5%

0.18%

Purity

Assay

Microbiological Analysis

Total plate count

Yeast and Moulds

E. Coli.

Salmonella

S.aureus

Storage

Preserve in well-closed, light-resistant and airtight containers.