If you ever wondered why the limit of detection (LOD) is actually calculated using the formula
LOD = 3.3 x standard deviation / slopecalibration curve
and where the 3.3 actually comes from, this article may shed some light on the subject.
In case analytical methods are evaluated for their suitability, the parameter "trueness" must also be considered during method validation for quantitative analyses of impurities as well as for content determinations and potency assays according to the method validation guideline ICH Q2(R1).
The various techniques of Raman spectroscopy find a wide range of applications in the different areas of the pharmaceutical industry, be it for the detection of counterfeits, as an in-process control (IPC) during the production of the active pharmaceutical ingredient, for content determinations, as an ID test for vaccines, for the simultaneous determination of several product quality attributes (PQAs) as part of a rapid release strategy, up to sterility tests, to name just a few examples [1-4].
Risk assessments are a good thing and can make life easier in the pharmaceutical environment. Everywhere it is said that this or that has to be or has been defined "risk-based"...
Hmm, all well and good, but where are the potential applications in the validation of analytical methods?
We’d like to make a deep dive into this question in today's blog post.