Items

Specifications

Results

Appearance

White or almost white, crystalline powder

White crystalline powder

Specific rotation

Meet the requirement

Complies

IR

IR spectrum of sample conforms to that of the reference standard

Complies

Appearance of solution

The solution is clear and not more intensely colored than reference solution BY₇

Complies

Specific optical rotation

+285^o~+300^o

+288.4^o

Sum of impurities E and F

Not more than 1.0%

0.26%

Sum of Impurities B and C

Not more than 0.8%

0.18%

Impurity A

Not more than 0.4%

0.03%

Impurity D

Not more than 0.4%

0.17%

Impurity G

Not more than 0.4%

0.13%

Unspecified impurity

Not more than 0.10%

0.08%

Sum of impurities (other than E and F )

Not more than 1.0%

0.72%

Heavy mentals

Not more than 20ppm

Less than 20ppm

Loss on drying

Not more than 0.5%

0.08%

Sulfated ash

Not more than 0.1%

0.03%

Ethanol

Not more than 5000ppm

588ppm

Assay (on the dried basis )

97.0% to 102.0% of C₂₅H₃₈ O₅

100.10%

Conclusion

The results conform with the specifications