Tofacitinib CAS: 477600-75-2 99 ٪

ITEMS

SPECIFICATION

RESULTS

Appearance

White solid

White solid

Identification

¹H NMR spectrun of the sample corresponds

to the reference spectrum

Conforms

Stereoisomers

(Chiral HPLC)

Enantiomer ≤ 0.20%

0.04%

Solvents(GC)

Ethanol ≤ 5000 ppm

800 ppm

Ethyl acetate ≤ 3000 ppm

500 ppm

Methanol ≤ 3000 ppm

N.D.

Toluene ≤ 890 ppm

N.D.

Water(KF)

≤1.0%

0.20%

Residue on ignition

≤0.1%

0.06%

Related substances

Unspecified impurity ≤ 0.10%

0.08%

Other unspecified impurity ≤ 0.10%

0.04%

Other unspecified impurity ≤ 0.10%

0.07%

Total impurities ≤ 0.10%

0.19%

Purity (RP HPLC)

≥99.0%

99.81%

Assay

(Material balance)

98.0% -102.0%

99.8%

Storage

Sealed and stored in a dry place at room temperature.