Elemental Impurities Analysis
The elemental impurities in drugs are trace metals that can be found in final products,
which may be harmful and must be controlled in the production process. 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. The
sources of elemental impurities include raw materials, production process, packaging
and container sealing system (CCS). They can interfere with the efficacy of drugs or
have a direct toxic effect on patients. Therefore, the elemental impurities analysis of
drugs is very important for drug quality control.
CD Formulation laboratory is cGMP-compliant and equipped with state of the art
analytical instruments. We have experienced analysis experts who can work with our
formulation and manufacturing team to provide you with drug elemental impurities
analysis services. Our elemental impurities analysis is performed in accordance with
pharmacopeia methods to give you reliable, independent data, which can help you to
make an appropriate risk assessment for your final drug products. In addition, we are
also able to develop and validate tailored methods of elemental impurities analysis
that will meet your specific needs.
