We are conducting the last operation in API Prossessing method that is LOD Or MC… What is the difference between both selection of last operations…
Manul pH
Moisture content plays a major role for the growth of microbes and is MC is more in a product is susceptible and provide optimal environment for growth of organisms. Also MC enhances the degradation of API and may lead to failure for assay and generation of impurities
Review flow chart and ROS,which solvents are using for the process of manufacturing accordingly your product might be solvated with that solvent.For quantification of product you should consider this.
LOD and Karl Fisher are primary methods of Analysis for determining moisture content
Using Halogen (or IR) moisture analyzer is a secondary method of Analysis for determining moisture content, so it needs standardization of its parameters (Drying temperature, Drying profile and shut off criterion, Sample size) depending on a primary method
Thanks, but it’s may not related to my question.
Download this Mettler white paper from the following link
The white paper title is:
Drying Oven vs. Halogen Moisture Analyzer: A Practical Guide to Compare Methods
It definitely contains the answer of your question
Thanks, but it’s may not related to my question.
what do you mean by the last operation in the API Processing method that is LOD Or MC? Is it for raw material or finished product?
It’s about finished,
Mostly last test completed with LOD or MC in inprocess controls. Depends on which basis we perform LOD or MC