Riociguat EP Impurity A

Riociguat EP Impurity A is chemically Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]pyrimidin-5-yl]carbamate (as per EP) ; Methyl {4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl]pyrimidin-5-yl}carbamate (as per USP). It is also known as Riociguat USP Related Compound A ; N-Desmethyl Riociguat. Riociguat EP Impurity A is supplied with detailed characterization data compliant with regulatory guideline. Riociguat EP Impurity A can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Riociguat.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.

Stability indicating RP-​HPLC method for estimation of riociguat in bulk & pharmaceutical dosage form
By Dichwalkar, Sanika A.; Hamrapurkar, Purnima D.
From World Journal of Pharmaceutical Research (2019), 8(13), 1258-1268

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