11.11.2014: Q3D elemental analysis: BioChem establishes ICP-MS technology
With the successful commissioning of our new ICP-MS system in July 2014, we have extended further element-specific determination procedures to the BioChem portfolio. Now that the ICH Q3D Guideline is progressing towards finalisation…
…the verification and quantification of trace quantities of metallic and other inorganic impurities in pharmaceutical raw materials and drug products will become increasingly important.
In separate rooms equipped specifically for ICP-MS, the qualification procedures were successfully completed in June 2014.
In a so-called 3-room concept, the weighing of the samples, preparation of the samples including sample digestion, and sample measurement were set up separately in order to ensure that an optimum laboratory environment for the avoidance of contamination was created.
ICP-MS technology serves as the perfect addition to the wet-chemical and spectrometric testing procedures such as, e.g. atomic absorption spectrometry (AAS), already used for many years at BioChem.
This means that BioChem is now in a position to meet the requirements of Ph. Eur. section 5.20 “Metal Catalyst or Metal Reagent Residues” and 2.4.20 “Determination of Metal Catalyst or Metal Reagent Residues”, as well as USP section <232> Elemental Impurities – Limits and <233> Elemental Impurities – Procedures.
At the present time (November 2014) the Q3D Guideline is currently in Step 4 as a draft version, the finalisation of which is expected before the end of the year.
Our elemental analysis team, headed by Annette Burkhard, can assist you firstly
– with the elemental screening of your raw materials and drug products, using a simple method in order to obtain a valid overview of the contamination profiles of your samples
– with the method establishment and validation pursuant to Ph. Eur. and USP, in order to establish routine measurements which are in compliance with your registration files, or to verify a Skip-Lot testing procedure by verification of compliance with the 30% control threshold based upon the PDE (Permitted Daily Exposure).
We can also assist you with the performance of risk analyses on the basis of Q3D, as well as the determination of relevant concentration limits on the basis of PDE limits.
All you have to do is contact us.
Dr. Jürgen Branke