ITEMS

SPECIFICATION

RESULTS

Appearance

white or almost white ,crystalline powder

white or almost white ,crystalline powder

Solubility

Practically insoluble in water and easily soluble in ethanol (96 percent)

Practically insoluble in water and easily soluble in ethanol(96 percent)

Identification

IR absorption spectrum of sample is in identical with that ofreference substance

IR absorption spectrum of sample is in identical

with that of reference substance

The residue does not give reaction(a)of sodium

The residue does not give reaction(a)of sodium

Water

1.4%～2.0%

1.7%

Sulfated ash

≤0.2%

0.01%

Related substance

Impurity M

≤1.0%

0.2%

Impurity G

≤0.7%

ND

Impurity L

≤0.5%

ND

Impurity B

≤0.4%

ND

Impurity A

≤0.3%

ND

Impurity H

≤0.10%

ND

Impurity C

≤0.2%

0.1%

Impurity D

≤0.2%

ND

Impurity F

≤0.2%

ND

Impurity I

≤0.2%

0.1%

Impurity K

≤0.2%

ND

Impurity N

≤0.2%

ND

Any other impurity

≤0.10%

0.07%

Total impurity

≤2.0%

0.7%

Assay(Anhydrous)

97.5.0%~101.0%

99.24%

Conclusion: The product complies with EP10.5