Impurities Identification Tests

Unexpected pollution, impurity, or contamination that suddenly appears in a QC or other analysis can create a lot of stress and anxiety in different departments of a pharmaceutical company.

In many cases, this unexpected contamination is not identified - at first - because they are initially detected by non-specific detectors in generic analytical methods such as HPLC-UV Chromatography.

This contamination can be observed during the full life cycle development of the drug product.

What is pollution?

As the regulatory department and the quality department try to evaluate the impact of this impurity on drug quality and safety, the first question that arises is: "What is it?" At first, this seems like an easy and straightforward question, but it can turn into a nightmare for the analytical chemistry department. For them it means:

• • An uncontrolled in-house approved process.
  • A complete change in priorities due to the high urgency of the problem.
  • Requirement of extensive expertise and access to high-level analytical techniques that allow for structure illumination, including accurate mass measurements such as LC-ToF or GC-ToF or other techniques such as NMR.
  • The need to finally access analytical standards (such as confirmation of retention time by HPLC-UV) to authenticate the impurity in routine QC analysis.

Where does the impurities come from?

"What is this?" Alongside the question, another question will arise: "Where does the unexpected impurity come from?" This is a critical question if the presence of this unexpected impurity must be avoided. The origin of the compound may also determine which guidelines (and relevant control limits) to follow in the final assessment of drug impurity. Relevant guidelines include ICH Q3A (Impurities in New Drug Substances), ICH Q3B (Impurities in New Drug Products), ICH Q3C (Impurities: Guidelines for Residual Solvents), ICH M7 (Assessment and control of DNA reactive impurities in pharmaceuticals to limit potential carcinogens risk), EMA , PQRI-PODP and PQRI-OINDP.

Impurities can be introduced into the drug product through different potential cause pathways, as explained in the root cause approach using Ishikawa fishbone.

EUROLAB, with its highly expert team and internationally accredited laboratories, Impurities Identification Tests It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.