We offer purification services appropriate to support both non-clinical and clinical studies.
Purification techniques routinely utilized include HPLC, flash and lobar chromatography, crystallization as well as preparative gas chromatography.
Purification services include:
Development of achiral and chiral purification method(s), as appropriate, to achieve exceptionally high levels of radiochemical purity, chemical purity, and chiral purity
- Meeting agreed upon purity specifications
- Purification will be done in one of our four state-of-the-art Class 7 cleanrooms for cGMP APIs
- Replacement of all wetted surfaces of the preparative HPLC system for cGMP APIs
- Use of five dedicated Agilent 1260 preparative HPLC systems for purification of cGMP APIs
- Only new HPLC preparative columns are used for purification of cGMP APIs
- Purification of cMP APIs carried out according to a master batch record
Some related services: