- Impurity standards – Small molecules and Peptides
- Stable Isotope Labelled standards using Deuterium and Carbon 13
- Metabolites and Glucuronides
- Stable isotopes of Metabolites and Glucuronides
Daicel Pharma Standards offers custom synthesis of target impurities of known structures. Our technical expertise and capabilities extend to characterization and isolation of unknown impurities. Our process starts with direct communication with our customers, discussing data and determining feasibility. After full characterization, the target impurity is then isolated through preparative HPLC/SFC chromatography or directly synthesized. The desired amount is delivered with a CoA from our FDA-compliant analytical lab.
We offer custom labelled synthesis of NCEs for customer pharmacokinetic studies. Daicel has the capacity to manufacture these high-purity/quality labelled NCEs in multi-gram scale.
We now also offer development of peptides from the stage of Feasibility, finding a patent free process, developing the whole Process including purification of peptides and supported by process and analytical validation and up to Technology Transfer to our clients.