General Information

Diazoxide Impurities and Diazoxide

Daicel Pharma specializes in synthesizing high-quality impurities for Diazoxide, an active pharmaceutical ingredient. The impurity, 2-Amino-5-chlorobenzenesulfonic Acid hydrochloride, plays a vital role in assessing the purity, reliability, and safety of Diazoxide. Daicel Pharma also offers a customized synthesis of Diazoxide impurities to cater to client requirements, with worldwide delivery options available.

Diazoxide [CAS: 364-98-7], a benzothiadiazine derivative, acts on hypertension and hyperglycemia. It is a peripheral vasodilator, useful in hypertensive emergencies. Diazoxide offers a versatile pharmacological profile that addresses various therapeutic needs.

Diazoxide: Use and Commercial Availability 

Diazoxide inhibits insulin secretion and promotes hepatic gluconeogenesis and glycogenolysis, limiting tissue glucose utilization. Consequently, it leads to elevated blood glucose levels (hyperglycemia). It also treats neonatal hyperinsulinism. It is available under brand names, including Hyperstat and Proglycem.

Diazoxide Structure and Mechanism of Action

The chemical name of Diazoxide is 7-Chloro-3-methyl-2H-1,2,4-benzothiadiazine 1,1-dioxide. Its chemical formula is C₈H₇ClN₂O₂S, and its molecular weight is approximately 230.67 g/mol.

Diazoxide interacts with ATP-sensitive potassium channels of pancreatic islet beta-cells and inhibits insulin release.

Diazoxide Impurities and Synthesis

Diazoxide impurities can form during manufacturing¹ or due to degradation over time. They are of concern as they can affect the quality, efficacy, and safety of the final product. The impurities can impact the drug’s stability, pharmacokinetics, and potential adverse effects. Therefore, rigorous analysis and control of Diazoxide impurities are essential to meet regulatory requirements and ensure patient safety. It includes thorough characterization and quantification of impurities and implementing measures to minimize their formation during manufacturing and storage.

Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Diazoxide impurity standards, including 2-Amino-5-chlorobenzenesulfonic Acid hydrochloride. They generate in an analytical facility that complies with cGMP standards. The CoA provides a detailed characterization report with data obtained through techniques such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity analysis². We give additional data like 13C-DEPT upon request. Daicel Pharma synthesizes unknown Diazoxide impurities or degradation products, and labeled compounds, to evaluate the efficacy of generic Diazoxide. Also, Diazoxide-D3, a deuterium-labeled Diazoxide standard, is available for bio-analytical research, including BA/BE studies. Every delivery accompanies a complete characterization report.