Hochreines Ruxolitinib-Pulver (941678-49-5)

Tests and Methods

Specifications

Results

Appearance

White or slightly yellowish,crystalline powder.

Conforms

Identification

(1) HPLC

The retention time of the major peak in the chromatogram of Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay

Identical

(2) IR absorbance Spectrum

Both the test sample and the reference standard exhibit the same intensity of absorption at the same wave number(wavelengths). (potassium bromide disk method)

Identical

Optical rotation

-60° to -70° (anhydrous substance).

 -62.56°

Water

N.M.T. 0.5%

0.09%

residue on ignition

N.M.T. 0.5%

0.35%

Purity

1) Related Substances

Impurity A: N.M.T. 1.5%

Impurity B: N.M.T. 0.5%

 Any other impurity: N.M.T. 0.9%

N.M.T one Impurity more than 0.5%

Total Impurities: N.M.T. 1.5%

 Not detected

 Not detected

 Not detected

Conforms

 Not detected

2) Residual solvents

Ethyl acetate: N.M.T. 0.5%

N-heptane:N.M.T. 0.5%

Acetone: N.M.T. 0.5%

n-Hexane: N.M.T. 0.029%

0.2180%

0.0118%

Not detected

Not detected

Assay

95.0~102.5% ( anhydrous and solvent free basis)

99.9%

Conclusion:  conforms to the requirements of EP7.0