Analytical Development and Stability Testing
The company division HERMES PHARMA maintains a special department for analytical development and stability testing with a highly qualified team of employees (pharmacists, food chemists, chemical, pharmaceutical engineers, pharmaceutical assistants, and chemical assistants) who work with the latest analytical methods.
We specialize in:
- Development, optimization and validation of analysis methods according to ICH requirements for both chemical-synthetic and active herbal ingredients as well as for the corresponding finished products generated by our galenic development
- Implementation of comprehensive stability testing programs under diverse climatic conditions and in various packaging materials according to ICH requirements
- Regular follow-up stability tests within the scope of our quality assurance program
- Special tests as requested by our customers
For your product development, we can offer you:
- Complete planning and implementation of tests
- Procurement and characterization of active substances and reference substances
- Compilation of test specifications
- Detailed validation reports
- Complete set of stability test reports
Our close contact with the department for Drug Regulatory Affairs ensures that prevailing regulatory requirements are observed, and we maintain air-conditioned storage facilities for stability testing as required by ICH.
We apply the following analytical methods:
- HPLC (high pressure liquid chromatography with UV, DAD and RI detectors)
- HPLC-MS (high pressure liquid chromatography with mass sensitive detectors)
- IC (ion chromatography with the following methods: UV detection, conductometry, pulsed amperometric detection (PAD), post-column derivatization)
- DC (thin-layer chromatography)
- UV/VIS SP (spectral photometry)
- Volumetry (titration stations with different indication methods)
- Dissolution test with paddles/baskets (EP 1&2), reciprocator cylinder (EP 3)
- Methods to record physical, chemical and technological parameters