ITEM

SPECIFICATIONS

RESULTS

Character

White or almost white crystalline powder

Crystalline powder

Identification

(1) complies by IR

(2) complies by TLC

Conforms

Conforms

Appearance of solution

Clear and not more than intensely colored than reference solution B7

Conforms

pH

7.5~9.0

8.4

Specific optical rotation

+94°~+100°

+98.0°

Related substances

Individual impurity is not more than2.0%

Not more than one impurity is greater than 1.0%

Total impurities not more than 3.0%

0.04%

Undetected

 0.24%

Inorganic phosphates

Not more than 1.0%

Conforms

Water

Not more than 8.0%

7.3%

Assay

C21H27Na2O8P calculated with dry basis 96.0% to 103.0%

97.6%

Conclusion: Conforms to the standard of EP7