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.
Custom Labelled Synthesis
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.
Custom Peptide Development
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.
We Synthesize
Impurity standards – Small molecules and Peptides
Stable Isotope Labelled standards using Deuterium and Carbon 13
Metabolites and Glucuronides
Stable isotopes of Metabolites and Glucuronides
We offer Analytical Services from US-FDA compliant Analytical Facility