Adenosine, 2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-, monohydrate;
1-(6-Amino-9-β-d-ribofuranosyl-9H-purin-2-yl)-N-methyl-1H-pyrazole-4-carboxamide monohydrate [875148-45-1]
BRIEFING
Regadenoson. 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 procedures for the Assay and Organic Impurities test were validated using the Alltima C18 brand of column with L1 packing. The typical retention time for regadenoson is about 27 min.
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The liquid chromatographic procedure for the Limit of Regadenoson Related Compound E test was validated using the Synergi Hydro-RP 80A brand of column with L1 packing. The typical retention time for regadenoson related compound E is about 3.6 min.
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The gas chromatographic procedure for the Limit of Methylamine test was validated using the OVI-G43 brand of column with phase G43. The typical retention time for methylamine is about 1.9 min.
Description and solubility information: White to off-white powder. Soluble in dimethylacetamide; slightly soluble in methanol and in ethanol; very slightly soluble in mixtures of propylene glycol and water; practically insoluble in water and in buffered aqueous solutions at pH levels between 2 and 7.5.
(SM4: S. Dragan)
Case ID—SUB-148
USP REFERENCE STANDARDS FOR PURCHASE
USP Regadenoson RSUSP Regadenoson Related Compound C RS
USP Regadenoson Related Compound D RS
USP Regadenoson Related Compound E RS