Method for detecting the extraction material of bio-pharmaceutical product

摘要

The present invention, by using a liquid chromatography mass spectrometry, manufacturing, to verify the presence or absence of extractables taken beyond a certain concentration biopharmaceutical product during filtration or storage. Using the methods disclosed herein are not to substitute the solvent system, it is possible to detect the presence of extractables in the actual biopharmaceutical product. Detection of extractables in the actual drug product provides an accurate content of leachable substances profiles that may be incorporated into a human or animal patient. In one embodiment, the extraction material is taken up by filtration of the biopharmaceutical product.