Proposed changes to USP chapters 232 and 233 on trace impurities would increase drug industry use of automated analysis, creating “huge number” of potential new customers says Thermo Fisher Scientific.
The revisions, as Thermo’s applications specialist Matthew Cassap explained, would see analysis methods like inductively coupled plasma (ICP) MS replace precipitation-based detection methods which can be prone “false positives.”
And, while ICP is an established and relatively straightforward technique compared with GC, correctly implementing it may pose something of a training challenge for pharmaceutical laboratories that are unfamiliar with it.
The pay off for this additional training effort, Cassap continued, is that ICP has a considerably reduced turnaround time that can significantly reduce the cost of analysis work.
Cassap also suggested the revisions would be a boost for Thermo’s ICP business as companies wishing to sell drugs in the US would be required to use one of the proposed analysis techniques.