Tofacitinib Citrate CAS: 540737-29-9

ITEMS

SPECIFICATION

RESULTS

Appearance

White to almost white solid

White solid

Identification

1H NMR spectrum of the sample corresponds to the reference spectrum

Corresponds to the reference  spectrum

Water

≤ 1.0%

0.20%

Residue on Ignition

≤ 0.1%

0.05%

Stereoisomers

(Chiral HPLC)

Enantiomer≤ 0.20%

Not found

Related substances

(RP HPLC)

Unspecified impurity: ≤ 0.10%

0.06%

Other Unspecified impurity: ≤ 0.10%

0.01%

Purity (RP HPLC)

≥99.0%

99.93%

Assay

98.0%~102.0%

99.9%

Solvents (GC)

Ethanol (5000ppm)

850ppm

Methanol（3000ppm）

Not detected

Toluene（890ppm）

Not detected

Storage

Sealed and stored in a dry place at room temperature, protected from light

Conclusion:   Conform with Enterprise Standard.