Do you need a working standard or impurity?
Our R&D staff has considerable experience in the preparation of working standards and impurities for our own products since several of them are commercialised in the US pharmaceutical market. Each working standard is provided with its certificate of analysis corresponding with the usual pharmacopeias (USP, EP, JP, etc).
We can help you assess the impurity profile of your product. In our semipreparative and preparative HPLC systems, we are able to isolate and purify impurities from mixtures. Our chromatographic Ø 2,5 cm and Ø 10 cm columns can be packed with a wide range of stationary phases, which allows us to deal with most of the chromatographic separations. Our programmable fraction collectors enable the exact repetition of the purification conditions in order to get the desired amount of the compound.
Additionally, we can propose and develop syntheses of potential impurities of your product, either to confirm the structure of an isolated impurity or to prepare working standards, and degradation products. We may also develop and validate analytical methods in collaboration with our QC department; besides, we could also carry out stability studies under ICH guidelines.
In the event that any additional technique would be needed, we have set an agreement to use the “Scientific and Technical Resources” of the University of Oviedo, located 10 Km away from Asturpharma’s facilities. The University of Oviedo has recently been recognized with an International Campus of Excellence regional award by the Spanish Government.