Reference Standards and Small Scale Syntheses

 
 

Substances & More

 
Health Authorities recommend well characterized standards as well as validated analytical methods. However, it is often very difficult to get this substances in a reasonable amount to validate e.g. an HPLC assay.
 
Analytical Services offers small-scale syntheses (up to 500g) of non-pharmacopeial substances and intermediates, full characterization and certification of the reference standards, as well as storage according to GMP/GLP conditions.
 

Customized reference standards.

Services:

 
PAT - Fitting your process into compliance
PAT, Design of Experiments (DOE)
Labelled compounds (stable isotopes)
Glucuronides, metabolites
Isolation, characterization and syntheses of degradation products
Pharmacopeial- and non-pharmacopeial substances
Substance Storage
According to GMP/GLP conditions
 

Relevant Links:

 
- ICH Guideline Q6A (pdf, 163 kB)
- ICH Q6A Decision Tree (pdf, 29 kB)
 

Process of Drug Development: