Analytical development
In addition to synthesis and drug development, we offer a comprehensive range of analytical services (incl. stability testing). Our range includes both routine analysis according to pharmacopoeial methods as well as the development of new analytical methods for drug substances and drug products.
Our analytical services in detail
- Method development and validation of quantitative analyses and purity tests in accordance with ICH Q2
- Determination of impurities (Impurity Profile) in drug substances and drug products in accordance with ICH Q3 A-C
- Quantitative analyses (e. g. by means of HPLC/DAD, GC/MS, titration)
- Studies on drug release (dissolution testing)
- Generation of specifications for APIs and drug products in accordance with ICH Q6A
- Pharmacopoeial analysis (Ph. Eur., USP, JP)
- Development and validation of stability-indicating analytical methods
- Stability testing in accordance with ICH Q1A
- Photostability testing in accordance with ICH Q1B
- In-use stability testing
- Transport and storage stress testing
- Storage of stability samples with external specialist provider
GC residual solvent determination
We have many years of experience in using gas chromatography (GC/MS, GC/FID) to determine residual solvents in pharmaceutical ingredients, drug substances (APIs) and drug products.
- Qualitative and quantitative determination of solvents (e. g. screening in accordance with ICH Q3C)
- Validation of residual solvent determination in various pharmaceutical matrices
Technical apparatus and range of methods
| HPLC with UV/DAD |
| GC MSD with HS and on-column, GC FID |
| UV/VIS spectrophotometry |
| HPLC with UV/DAD |
| GC MSD with HS and on-column, GC FID |
| UV/VIS spectrophotometry |
| Refractive index |
| Dissolution test |
| DSC (differential scanning calorimetry) |
| Capillary viscosimetry |
| Photostability |
| Microscopy |
| Osmolality |
| pH value |
| Polarimetry |
| Melting range |
| Titration |
| Water determination (Karl Fischer method) |
