ESA Biosciences has a new technical poster describing how the Corona Cad enables routine measurement of low-nanogram levels of organic impurities in active pharmaceutical ingredients
The measurement of the level of organic impurities in an API is critical to the development and manufacturing process.
The level of organic impurities - which may include unreacted starting materials, by-products, intermediates, degradation products, reagents, ligands, and catalysts - is tightly controlled and heavily regulated to ensure patient safety.
Many of the impurities present in pharmaceutical preparations are difficult to measure with traditional technologies because they have poor UV signal or may lack any chromophore at all.
This problem is especially acute with newer pharmaceutical preparations involving the formulation of proteins, peptides, or complex molecules in lipid or polymer-containing formulations.
In this study, the Corona charged aerosol detector (Cad) was tested for its ability to quantitate organic impurities (0.05-10% level) in a series of APIs.
The isocratic HPLC method used in the study reproducibly and accurately measured non-chromophore and chromophore-containing impurities down to the 0.005% level independent of chemical structure.
The method also showed excellent precision (RSD <2.5%) for a nebulisation technique and offered a dynamic detection range from micrograms to nanograms.
The Corona Cad system offers many advantages over other HPLC detection methods (UV, ELSD, CLND, and LC-MS) that historically have been used for impurity testing.
These include low-nanogram sensitivity, a dynamic range exceeding four orders of magnitude, good precision response factors that are independent of structure, and no/low analyte level response 'drop-off'.
The ideal complement to UV detection, Corona Cad provides HPLC detection of non-volatile and many semi-volatile compounds, making it a valuable technique for detecting organic impurities.
Corona Cad is a robust, reliable, plug-and-play device requiring minimal training to operate.
Corona Cad has been adopted widely by many leading pharmaceutical companies worldwide because it addresses analytical challenges that remain unresolved with other technologies.
A copy of this technical poster is available online or by contacting your local ESA Biosciences representative.
