Benzenesulfonamide, 5-[[4-[(2,3-dimethyl-2H-indazol-6-yl)methylamino]-2-pyrimidinyl]amino]-2-methyl-, monohydrochloride;
5-({4-[(2,3-Dimethyl-2H-indazol-6-yl)methylamino]pyrimidin-2-yl}amino)-2-methylbenzenesulfonamide monohydrochloride [635702-64-6]
BRIEFING
Pazopanib Hydrochloride. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed.
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The liquid chromatographic procedure in the Assay was validated using the Purospher STAR RP18e brand of column with L1 packing. The typical retention time for pazopanib is about 4 min.
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The liquid chromatographic procedure in the Organic Impurities test was validated using the Purospher STAR RP18e brand of column with L1 packing. The typical retention time for pazopanib is about 26 min.
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The liquid chromatographic procedure in the Limit of Pazopanib Related Compound A and Pazopanib Related Compound B test was validated using the Purospher STAR RP18e brand of column with L1 packing. The typical retention times for pazopanib related compound A and pazopanib related compound B are about 9 and 13 min, respectively.
Manufacturers are encouraged to share any information pertaining to the mutagenicity of pazopanib related compound A and pazopanib related compound B with USP.
Description and Solubility information: White to slightly yellow color powder. Practically insoluble in ethanol and in water.
(SM3: R. Muppa)
Case ID—SUB-54
USP REFERENCE STANDARDS FOR PURCHASE
USP Pazopanib Hydrochloride RSUSP Pazopanib Related Compound A RS
USP Pazopanib Related Compound B RS