top of page

Cleaning Validation Glossary


Technique separating compounds

Chromatography is defined in USP <621>, Chromatography, as "a procedure by which solutes are separated by a dynamic differential migration process in a system consisting of two or more phases, one of which moves continuously in a given direction and in which the individual substances exhibit different mobilities by reason of differences in adsorption, partition, solubility, vapor pressure, molecular size, or ionic charge density. The individual substances thus separated can be identified or determined by analytical procedures". There are many types of chromatography methods such as high pressure liquid chromatography (HPLC), gas chromatography, ion exchange chromatography, ion exchange chromatography, and gel permeation chromatography. The selection of the method depends on the analyte. however, HPLC and gas chromatography are the most widely used. In validation of chromatography methods the system suitability, specificity, accuracy, precision, linearity, LOD and LOQ, range, and ruggedness are validated.

How Can We Help?

Tell us what you're looking to achieve.  We'll put our experience to work to solve your specific problem.  If you have any questions or inquiries, please do not hesitate to contact us. Our team is here to assist you and provide you with the information you need.

bottom of page