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Purification and impurities
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Identification and preparation of your impurity
Enantia is able to quickly identify and synthesize your impurity, including nitrosamines, in drug substances and drug products. Reference strandards of the impurities can also be provided.
At Enantia we have twenty years of experience in isolating, characterising and synthesizing impurities, even if these are out of specification impurities or nitrosamines. We are able to isolate and characterise impurities which are present in a drug substance, as well as in a drug product.
Our contract research services related to impurities include:
- Direct analysis of the sample containing the impurity to obtain accurate mass, possible molecular formula and fragmentation patterns with state-of-the art analytical equipment.
- Enrichment of the impurity in the mixture.
- Isolation of the impurity by an appropriate method, e.g. HPLC or MPLC.
- Impurity formation studies, including stress tests.
- Proposal of possible structures of the impurity.
- Custom synthesis of the proposed structure of the impurity. The data and spectra for the isolated impurity and the synthesized proposed impurity are compared for confirmation of the structure. Spiking studies are also performed.
- Preparation of a reference standard of the impurity for analytical method development use.
Furthermore, upon customers request, we can also scale the impurity to a sufficient quantity in a fast and efficient manner, allowing the customer to perform all relevent toxicology studies.
