The QC testing of drug compounds is performed on a worldwide scale by pharmaceutical companies, contract research labs (CRO) and various other institutions. Regulatory requirements are broader and more stringent than ever before and will only increase to protect human and nature. With the Current Good Manufacturing Practices (cGMPs) for human pharmaceuticals quality standards are set to insure product quality and safety. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. Reproducible, reliable and robust methods of analysis play a vital role in regulatory compliance.
Antec’s ALEXYS analyzers are used worldwide to meet USP and EP regulatory and safety standards for a broad range of compounds. Dedicated analyzers have been developed offering exceptional sensitivity, selectivity, and throughput for aminoglycoside and macrolide antibiotics, (di-) sulfides, glycoproteins, carbohydrates and several other pharmaceuticals.
Also in drug development regulatory agencies, such as FDA, USP and EP require more sensitive and accurate testing of drug candidates. The elucidation of the metabolic fate of drug candidates in the human body is one of the major challenges in pharmaceutical research. The main route of drug elimination is an enzymatic biotransformation. These are frequently initiated by oxidation reactions (“phase I metabolism”), which are catalyzed by enzymes of the cytochrome P450 superfamily. With a strongly increasing number of novel chemical entities in recent years, rapid screening techniques that provide both reliable and easily accessible information about the biotransformation of a drug candidate are required.
The ROXY Systems for on-line Electrochemistry (EC)/MS have shown great potential for metabolic profiling of drug compounds and xenobiotics. EC is one of the classical methods to induce oxidation reactions. It is therefore obvious to employ EC as simulation technique in drug metabolism studies. Electrochemical flow-through cells coupled on-line to MS have become the technique of choice for these simulation experiments. They provide exhaustive information about the nature of the electrochemically generated metabolites. The resulting time and cost savings are substantial when compared with daunting in vivo or in vitro experiments.