ITEM

SPECIFICATIONS

RESULTS

Appearance

White or almost white crystalline powder

 White crystalline powder

Identification

A:IR spectrum of the sample should conform to that of the reference standard.

Conforms

B.HPLC：In the item of related substances test ,the retention time and size of the principal peak in the test solution is accordant with that of reference solution (C)

Conforms

Specific optical rotation

+162～+168 °

+163.9°

Loss on drying

≤1.0%

0.1%

Related substances

Impurity A ≤ 0.2%

0.03%

Impurity B ≤ 0.2%

Not detected

Impurity C ≤ 0.5%

0.03%

Impurity D ≤ 0.5%

Not detected

Impurity E ≤ 0.5%

Not detected

Impurity F ≤ 0.3%

Not detected

Impurity G ≤ 0.4%

0.11%

Impurity H ≤ 0.15%

Not detected

Impurity I ≤ 0.5%

Not detected

Impurity N ≤ 0.15%

Not detected

                 Individual unknown impurity ≤ 0.10%

0.08%

Total impurities ≤2.0%

0.41%

Assay

97.0% ~103.0% of C₂₁H₃₀O₅ calculated by dry basis

100.3%

Conclusion: It conforms to the requirements of EP10.