Item

Standard

Structural data confirmation

1. H-NMR: The data of structure are identical with reference standard

2. HPLC-MS: Ensure the molecular weight of main peak and fragment peak are identical with reference standard

3. IR:The data of IR are identical with that of reference standard

Purity(HPLC)

≥99.0%

Related impurities

Specific single impurity

Meets EP/USP/BP standards

Non-specific single impurity

≤0.10%

Total Impurities

≤0.50%

Crystal form

Meets EP/USP/BP standards

Loss on drying

≤1.0%

Water

≤1.0%

Inorganic salt

≤0.1%

Heavy metals

≤10 ppm

Assay

99.0%~101.0%(According to EP/USP/BP standards)

Microbiological Analysis

Total plate count

≤1000cfu/g

Yeast and Moulds

≤100cfu/g

E. Coli.

Absent

Salmonella

Absent

S.aureus

Absent