Solid Phase Extraction (SPE) is one of the sample preparation techniques used in pharmaceutical laboratories. Its main purpose is the purification, concentration, and selective isolation of analytes from complex matrices, such as active pharmaceutical ingredients (APIs) and impurities.
In a GMP environment, SPE plays a significant role in both qualitative and quantitative analyses, including the determination of organic impurities, nitrosamines, degradation products, and trace levels of APIs. Thanks to the high selectivity of sorbents, matrix interferences can be effectively reduced, which directly translates into the reliability and reproducibility of results obtained by HPLC, GC, or LC–MS analyses.
From a GMP perspective, the SPE technique must be:
- validated (recovery, precision, reproducibility),
- reproducible and documented,
- risk-controlled (selection of sorbent, solvent purity, risk of cross-contamination).
The use of SPE standardizes the sample preparation process, which is particularly important during quality control of production batches and stability studies.
In summary, SPE is not only an analytical tool but also an integral part of the GMP quality system, supporting regulatory compliance, data integrity, and high-quality results in a modern pharmaceutical laboratory.
If you are looking for opportunities to apply this technique to your samples, please email contact@mtlab.pl or call +48 577 677 444.
