The Radiation Sterilization of Ertapenem Sodium in the Solid State

Abstract

For the first time, the influence of ionising radiation on the physicochemical properties of ertapenem in solid state was studied. During our studies, we evaluated the possibility of applying radiosterilization to obtain sterile ertapenem. Spectroscopic (Fourier Transform Infrared (FT-IR)), thermal (differential scanning calorimetry (DSC), chromatography (High-Performance Liquid Chromatography (HPLC) and HPLC-MS), and X-ray powder diffraction (XRPD) studies shown that irradiation of ertapenem with the 25 kGy, the dose required to achieve sterility, does not change the physicochemical properties of the studied compound. The antimicrobial activity of ertapenem irradiated with the dose of 25 kGy was only reduced for one species. Based on the received results, we can conclude that radiostelization is a promising alternative method of obtaining sterile ertapenem. In our studies, ertapenem was also exposed to e-beam radiation with a dose of 400 kGy. It was determined that two novel degradation products that are structurally differently to degradants formed during hydrolysis and thermolysis.

Do Rutin and Quercetin Retain Their Structure and Radical Scavenging Activity after Exposure to Radiation?

“…Because of this, it is important to evaluate the effects of ionizing radiation on drugs. The impact of radiation can be monitored by a variety of analytical methods, such as electron paramagnetic resonance (EPR), Fourier-transform infrared spectroscopy (FT-IR), high-pressure liquid chromatography (HPLC), and liquid chromatography-mass spectrometer (LC-MS) [ 23 , 24 , 33 , 34 , 35 , 36 , 37 ].…”

Antioxidant Potential of Resveratrol as the Result of Radiation Exposition

“…The literature reports on the chemical instability of many compounds of natural and synthetic origin after exposure to ionizing radiation [ 17 , 18 , 19 , 20 ]. There is also evidence that many substances are resistant to ionizing radiation [ 21 , 22 , 23 , 24 ]. Therefore, ionizing radiation can be used to obtain sterile forms of drugs (25 kGy) or to achieve adequate microbiological purity (15 kGy).…”