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.
A total of twenty-four elemental impurities are listed in the ICH Q3D guideline. The PDE limits are shown in the table below:
|Oral PDE (µg/day)||5||5||15||30||50||100||200||8||100||100||100||100||100||100||150||150||100||550||1200||1400||3000||3000||6000||11000|
|Parenteral PDE (µg/day)||2||5||15||3||5||10||20||8||100||10||10||10||10||10||80||10||10||250||90||700||1500||300||600||1100|
|Inhalation PDE (µg/day)||2||5||2||1||3||1||5||8||1||1||1||1||1||1||130||7||1||25||20||300||10||30||60||3|
If you have a requirement about elemental impurities analysis services, please contact us by phone or email, our colleagues will reply to you within three working days.