Impurities are chemical species that differ from the chemical compositions of desired materials or compounds. Impurities that reveal during quality control or other processes may pose unexpected or adverse effects on the development of products, especially medical devices and pharmaceuticals. In order to minimize the occurrence of unexpected impurities in the manufacturing process, it is important to discover the origins of impurities.
Impurity identification is the process of using various analytical techniques to elucidate the identity of unknown substances in pharmaceuticals, medical devices, combination medicinal products or consumer products. Three types of impurities are commonly evaluated in impurity identification: organic impurities, inorganic impurities, and residual solvents. In fact, identifying and characterizing impurities is important for both product development and safety reasons, as they may be harmful to the health of users.
Various organizations, such as FDA and ICH, have established guidelines for the identification of impurities as well as acceptance criteria, identification thresholds, and identification procedures in medical devices or drug products. Specifically, USP general chapter “Impurities in Drug Substances and Drug Products” and USP "Organic Impurities in Drug Substances and Drug Products" stated regulations for pharmaceutical impurities, while USP and stated guidelines for elemental impurities.
STEMart provides impurity identification services for the medical device, pharmaceutical product, and consumer product industries using a variety of techniques under standard requirements. These Impurity Identification services include but are not limited to the isolation, analysis and identification of impurities. In addition, the scientific team of STEMart can develop and validate strategies to help with impurity monitoring for research customers.
STEMart's Analytical Techniques
1) Chromatography: HPLC, LC/MS, GC/MS, GC/FID, GC/TCD, GPC/SEC
2) Spectroscopy: ICP-MS, NMR, MS, PXRD, TF-XRD, UV-Vis, FTIR, Raman
3) Microscopy: SEM, TEM, AFM, STM, LSCM
4) Other: TGA, DSC, TOC, BET Surface Area/Pore Size Analyzer
STEMart offers comprehensive sterility testing for pyrogen-free products. With extensive expertise in microbiology and sterility testing, STEMart can provide full support for manufacturers in meeting regulatory goals and minimizing compliance risk.
If you have additional questions about API Impurity Identification services for medical devices or would like to know more about STEMart’s medical device development service, please visit https://www.ste-mart.com.
about STEMart
STEMart is an industry-leading eCommerce platform incorporated with an extensive global footprint and a broad portfolio of more than 10,000 products. It aims to provide better lab materials, medical instruments and consumables, excellent technologies, and high-quality services to global customers in the fields of science, technology, and engineering, from the discovery stage upward to the manufacturing process. STEMart is dedicated to making research and biotech production simpler and safer in order to enhance access to better health worldwide.
