Custom Impurity Synthesis
Daicel Pharma Standards offers custom synthesis of target impurities of known structures. The Daicel Pharma Standards highly experienced and qualified scientific team is capable of synthesizing even the most complex impurities (not limited to small molecules) as well as peptides. Our project management system ensures seamless communication with customers and on time deliveries with assured quality.
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 Labeled Synthesis
Daicel Pharma Standards offers custom labeled synthesis of NCEs for customer pharmacokinetic studies. Daicel has the capacity to manufacture these high-purity/quality labeled NCEs in multi-gram scale.
All Daicel Custom synthesized standards are supplied with certificates of analysis (CoA) from our US-FDA compliant analytical lab. Our standard CoA contains:
- Identification by 1H-NMR and mass spectrometry
- Purity test by either HPLC or GC
- Potency assignment post TGA study or Q NMR
- Other tests if requested by customer