1-Piperidinepropanenitrile, 4-methyl-3-(methyl-7H-pyrrolo[2,3-d]pyrimidin-4-ylamino)-β-oxo-, (3R,4R)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1);
3-{(3R,4R)-4-Methyl-3-[methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino]piperidin-1-yl}-3-oxo-propanenitrile 2-hydroxypropane-1,2,3-tricarboxylate [540737-29-9]
BRIEFING
Tofacitinib Citrate. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is being proposed.
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The liquid chromatographic procedures in the Assay and the Organic Impurities test were validated using the YMC-Triart C18 brand of column with L1 packing. The typical retention time for tofacitinib is about 9 min in the Assay and about 10 min in the Organic Impurities test.
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The liquid chromatographic procedure in the Limit of Tofacitinib Related Compound B test was validated using the Chiralpak ID brand of column with L126 packing. The typical retention time for tofacitinib related compound B is about 13 min.
Description and solubility information: White to off-white powder. Soluble in dimethylsulfoxide and ethanol; slightly soluble in water.
(SM2: M. Fadadu)
Case ID—SUB-1771
USP REFERENCE STANDARDS FOR PURCHASE
USP Tofacitinib Citrate RSUSP Tofacitinib Related Compound A RS
USP Tofacitinib Related Compound B RS