Elemenal Impurities

ALS laboratories offer drug manufacturers with metal analysis tailored to individual needs - from the determination of a single element through element sets defined in ICH Q3D or USP <232> up to final protocols with over 60 elements.

The ICH Q3D Guideline, which addresses the determination of metals as impurities in pharmaceutically significant substances, has already reached an implementation phase; ICH Q3D covers both new drugs and new products containing pre-existing medicinal substances.

The Guideline has also been adopted by the European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) and the corresponding USP chapters come into effect on 1 January 2018. Hence, drug manufacturers are faced with the need to take into account all 24 elements identified in ICH Q3D in risk analysis and to act responsibly concerning determination of selected elements. The most significant threat, of course, are the metals used in the manufacturing of a drug as a catalyst; however, other sources, for example, manufacturing equipment, solvents used, water or excipients also need to be considered.

During the risk analysis, a general analytical method can be used and, based on the results, the elements to be analysed regularly using a specifically validated method can be selected.

Thanks to modern ICP-MS instrumentation and many years of experience with pharmaceutical matrices, specific validations according to ICH Q2 (R1), USP <233> and Ph.Eur 2.4.20 are included in the routinely service provided by ALS Czech Republic.