Elemental Impurities Analysis
RSSL can support the implementation of the upcoming elemental impurities changes. We can develop and validate methods specific and sensitive enough to determine levels of elemental impurities present in raw materials, APIs and finished products in accordance with ICH Q3D guidance.
Since the ICH Q3D was published in December 2014 the USP and EP have harmonised their approach to reflect these fundamental changes to the analysis of elemental impurities. Winter 17/18 will see these chapters (EP 5.20 in December 17, and USP<232>/<233> in January 18) become effective.
ICH Q3D uses an elemental classification system. The approach to elemental impurities testing is based on toxicity studies and the use of risk based assessments of the materials (API and excipients) and processes used in the finished product manufacture to establish a suitable testing programme for the raw materials/final drug product.
We have a dedicated and experienced metals analysis team who work with our customers to plan and deliver appropriate method development, feasibility, validation and subsequent testing on the required materials for the selected elements established in the risk assessment process.
Our modern, well-equipped laboratory has a wide range of preparation and analytical techniques, allowing for efficient preparation and analysis of samples. This ensures that validations are performed successfully in compliance with all relevant guidelines enabling the final method(s) to be ready for both regulatory submissions and routine testing as part of quality control procedures.
- Inductively Coupled Plasma-Mass Spectroscopy (ICP-MS)
- Inductively Coupled Plasma-Optical Emission Spectroscopy (ICP-OES)