Earlier this month, the US-based contract service provider CD Formulation announced that its management has decided to further optimize its elemental impurities analysis services. Previously, the company has already released a wide array of drug analytical services, covering bioavailability/bioequivalence detection, disintegration test, dosage unit uniformity test, microbial limits test, tablet fragility test, dissolution test, tablet hardness test and more.
Any elements that are not meant to be present in the final formulation of a drug product are called elemental impurities. Proper analysis of elemental impurities is of paramount importance in pharmaceutical formulations in order to avoid potential safety and toxicological risks.
“Risk assessment and management is one of the priority tasks. Pharmaceutical manufacturers must take all the potential sources of impurities into consideration. In addition to container systems and manufacturing processes, impurities can come from excipients, catalysts, formulation ingredients, water, or the active pharmaceutical ingredients themselves,” says a senior scientist from CD Formulation. “It is often a great challenge to find and specify the concentration of the trace elements in drug products.”
After years of practice and with strong expertise knowledge, CD Formulation is now capable of providing cGMP-accredited elemental impurities analysis for pharmaceutical or drug substance manufacturers. The limits of drug elemental impurities are determined by the regulatory agencies of the corresponding countries/regions, such as the USP, ICH, Ph. Eur., ChP and JP.
Many analytical techniques can be used for elemental impurities analysis, including Ion Chromatography (IC), Flame Atomic Absorption Spectroscopy (FLAA), X-ray Fluorescence (XRF), Atomic Absorption Spectrometry (AAS), Atomic Emission Spectrometry (AES), etc. Moreover, via the use of Inductively Coupled Plasma – Mass Spectrometry (ICP-MS) and Inductively Coupled Plasma – Optical Emission Spectroscopy (ICP-OES), metal elemental impurities can be monitored and analyzed.
The elemental impurities analysis services offered by CD Formulation are conducted in strict accordance with the United States Pharmacopeia (USP) and the International Conference on Harmonization (ICH) guidelines. The ultimate goal is to help ensure the safety and quality of either drug substances or finished drug products. Please visit https://www.formulationbio.com/elemental-impurities-analysis.html for more information.
Ever since its establishment, CD Formulation aims to be a science-driven company devoted to drug formulation research. It is now qualified to serve the pharmaceutical industry providing CRO services to develop, produce and design pharmaceutical excipients. It has completed several development projects and proudly extends its capability day by day. The high-profile experts at CD Formulation are striving to address the long-standing issues that come from new active pharmaceutical ingredient (API) development.
