Earlier this month, US-based contract services provider CD Formulation announced that its management has decided to further optimize its elemental impurity analysis services. Previously, the company has already released a wide range of drug analysis services, covering bioavailability / bioequivalence detection, disintegration test, dosage unit uniformity test, microbial limit test, tablet brittleness test, dissolution test, tablet hardness test and Moreover.
All the elements that are not expected 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 should consider all potential sources of impurities. In addition to container systems and manufacturing processes, impurities can come from excipients, catalysts, formulation ingredients, water, or the active pharmaceutical ingredients themselves, ”explains a senior scientist at CD Formulation. “It is often a great challenge to find and specify the concentration of trace elements in pharmaceuticals.”
After years of practice and with a solid knowledge of the expertise, CD Formulation is now able to provide cGMP accredited emental impurities analysis for manufacturers of pharmaceuticals or medicinal substances. The limits of the elemental impurities of the drug are determined by the regulatory bodies of the corresponding countries / regions, such as USP, ICH, Ph. Eur., ChP and JP.
Many analytical techniques can be used for the analysis of elemental impurities including ion chromatography (IC), flame atomic absorption spectroscopy (FLAA), X-ray fluorescence (XRF), atomic absorption spectrometry (AAS) ), atomic emission spectrometry (AES), etc. In addition, through the use of inductively coupled plasma – mass spectrometry (ICP-MS) and inductively coupled plasma – optical emission spectroscopy (ICP-OES), elemental metallic impurities can be monitored and analyzed.
The elemental impurity analysis services offered by CD Formulation are performed in strict accordance with the guidelines of the United States Pharmacopoeia (USP) and the International Conference on Harmonization (ICH). The ultimate goal is to help ensure the safety and quality of drug substances or finished pharmaceutical products. Please visit https://www.formulationbio.com/elemental-impurities-analysis.html for more information.
About CD formulation
Since its inception, CD Formulation has aimed to be a science-driven, drug formulation research company. She is now qualified to serve the pharmaceutical industry by providing CRO services to develop, produce and design pharmaceutical excipients. It has carried out several development projects and is proudly expanding its capacity day by day. The top experts at CD Formulation are working to solve long-standing challenges in the development of new active pharmaceutical ingredients (APIs).