Impurity identification and characterisation.
At Enantia we have over a decade of experience in isolating, characterising and synthesizing impurities. We are able to isolate and characterise impurities which are present not only in a drug product, but also in a drug substance and the preceeding steps. Typically we work in the following manner:
- If the amount of impurity in the sample is deemed to be too low to be directly isolated, the quantity of the impurity in the mixture is enriched using a variety of techniques we have available to us.
- The impurity is then isolated by an appropriate method, e.g. HPLC or MPLC, and with the full support of the analytical department.
- Based on the data and spectra generated from the isolation of the impurity, a structure of the impurity is then proposed.
- Following retrosynthetic analysis, the proposed structure of the impurity is then synthesized de novo. The data and spectra for the isolated impurity and the synthesized proposed impurity are compared for confirmation of the structure.
Upon customers request, we can then scale the impurity to a sufficient quantity in a fast and efficient manner, allowing the customer to perform all relevent toxicology studies.
We also provide HPLC method development in detection of the impurity. This involves submitting the sample to various conditions such as solvents, columns, temperature, and time, and optimising the run so that the impurity is as best separated as can be from the other components of the sample.