ICP-MS analysis is routinely used to meet ICH Q3D requirements for Elemental Impurities in accordance with the Ph Eur and USP. It was a logical move to show the equivalence of this test to the established Graphite Furnace Atomic Absorption Spectroscopy (GFAAS) outlined in the monographs for Magnesium Stearate.
The reason for this methodology shift is prompted by a reduction in requests for analysis using GFAAS and AAS, especially following the introduction of ICP-MS in the Elemental Impurities general chapters. As such it is becoming harder for contact laboratories to justify the replacement of Atomic Absorption Spectrophotometers (AAS) as they come to the end of their life cycle.
There are already signs that the pharmacopoeias are replacing older metallic methodologies with elemental impurities analysis and this trend is likely to continue. Validation and verification will be something that outsourcers will need to consider as this change gathers pace. Butterworth are perfectly placed with the right experience and knowledge to help you get one step ahead and to provide more robust methodology.
