ITEMS

SPECIFICATION

RESULTS

Appearance

White to off-white powder

White powder

Identification

IR:Sample spectrum corresponds to that of standard spectrum.

Complies

HPLC: The retention time of main peak of test product is consistent with that of standard

Complies

Loss on drying

NMT 1.0%

0.06%

Water content

NMT 0.5% (By KF)

0.1%

Optical Rotation

Between -7.5° ~ -9.5° （C=0.5,methanol）

-8.7°

Heavy Metal

NMT 10ppm

Complies

Related substance

20H01 NMT 0.1%

ND

20H02 NMT 0.1%

ND

20H04 NMT 0.1%

ND

20HIb NMT 0.3%

0.02%

20H21 NMT 0.1%

ND

Any individual impurity ≤0.1%

0.02%

Total impurities ≤0.5%

0.1%

Residual solvent

Ethanol ≤ 5000ppm

ND

Methylene dichloride ≤ 600ppm

ND

Acetonitrile ≤ 410ppm

ND

N-Heptane ≤ 5000ppm

ND

Acetone ≤5000ppm

ND

Isopropyl acetate ≤5000ppm

ND

Ethyl acetate ≤5000ppm

ND

Isopropanol ≤5000ppm

40ppm

Purity

NLT 99.5% (230nm)

99.9%

Assay (HPLC)

98.0% ~102.0%

99.6%

Conclusion: The test results are conformed to the in-house specification