At EP our team of scientists routinely provides assistance with R&D method development, validation, method transfer and analysis services. We offer proprietary assays and assay development to analyze biological samples including but not limited to blood plasma, serum, tissue, urine and feces, as well as raw materials, formulated products and environmental samples. Alternatively, we can also follow already established methods that have been validated.
Analysis by USP monograph procedures, such as HPLC assay, related substance, identification, uniformity, loss on drying, osmolality and pH are available.
Preparative Liquid Chromatography (Prep-LC) Purification Services
At Emery Pharma, we offer small to large scale reverse-phase (prep-LC) and normal-phase (flash chromatography), which is used to isolate desired compounds or impurities for subsequent evaluation and/or structural determination. Our wide range of reverse-phase columns (C18 columns up to 3 inches internal diameter and 2 feet long!) allows us to work with sample sizes from 10 mg to 5 grams per run. If you have an R&D project that requires isolation of natural products from complex matrices, such as plant material or microbial culture media, we can help. Isolation of decomposition impurities from a drug product is another one of our specialties. If you are at the pre-registration stage with the FDA, EMA, or Japan PMDA and there are specific requirements for characterization, we can provide you with full service characterization of your active pharmaceutical ingredient (API) and minor impurities.