Vericiguat

General Information

Vericiguat Impurities and Vericiguat

Daicel Pharma is a reliable partner for synthesizing high-quality Vericiguat impurities, specifically 5-fluoro-1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridine-3-carboxamide, Vericiguat Carboxidamide Hydrochloride Impurity, Vericiguat Carboxylic Acid Impurity, and Vericiguat Nitrile Impurity. These impurities help assess the quality, stability, and safety of the active pharmaceutical ingredient, Vericiguat. Daicel Pharma also offers a custom synthesis of Vericiguat impurities, which can be shipped worldwide to meet customers’ unique requirements.

Vericiguat [CAS: 1350653-20-1] is a medication that manages and treats heart failure with reduced ejection fraction (HFrEF). It is a novel oral soluble guanylate cyclase stimulator for treating chronic heart failure.

Vericiguat: Use and Commercial Availability  

Vericiguat reduces the risk of cardiovascular death and heart failure-related hospitalization in adults with symptomatic, chronic heart failure. Vericiguat prevents rehospitalization for heart failure patients. The tradename for Vericiguat is Verquvo.

Vericiguat Structure and Mechanism of Action

The chemical name of Vericiguat is Methyl [4,6-diamino-2-[5-fluoro-1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl]pyrimidin-5-yl]carbamate. Its chemical formula is C₁₉H₁₆F₂N₈O₂, and its molecular weight is approximately 426.4 g/mol.

Vericiguat stimulates soluble guanylate cyclase (sGC), an enzyme in the Nitric Oxide (NO) signaling pathway. The enzyme increases the level of intracellular cGMP resulting in smooth muscle relaxation and vasodilation.

Vericiguat Impurities and Synthesis

Vericiguat impurities can arise from various sources, such as starting materials, synthetic reactions, and storage conditions. The most common impurities in Vericiguat are related to its synthetic process¹ and may include byproducts, degradation products, and solvents. These impurities can impact drug stability, pharmacokinetics, and toxicity. Therefore, it is crucial to control Vericiguat impurities by implementing appropriate manufacturing processes, analytical methods, and quality standards.

Daicel Pharma provides a Certificate of Analysis (CoA) for Vericiguat impurity standards, which includes 5-fluoro-1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridine-3-carboxamide, Vericiguat Carboxidamide Hydrochloride Impurity, Vericiguat Carboxylic Acid Impurity, and Vericiguat Nitrile Impurity. The CoA is from an analytical facility that adheres to current Good Manufacturing Practices (cGMP) and includes complete characterization data, such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity². We give additional characterization data such as 13C-DEPT and CHN on request. Daicel Pharma can also generate unknown Vericiguat impurities or degradation products and provide labeled compounds to assess the effectiveness of Vericiguat. Further, Daicel Pharma offers Vericiguat-D3 HCl, a deuterium-labeled Vericiguat compound used in bio-analytical research, such as BA/BE studies. A complete characterization report is a part of each delivery.