Analytical Services
Our expert team of analytical scientists can develop or perform technical transfer of IPC and release methods using an extensive range of analytical techniques and equipment.
High Quality Analysis of Chemical Products
Hit Chemics analytical teams in the UK, Switzerland, Slovakia and China work alongside manufacturing to develop and maintain the appropriate techniques and methodologies to support process development, In-Process Control (IPC) testing and product characterization testing for our fine chemical products. This applies to both our catalog products and to those produced for CDMO customers. In the state-of-the-art Swiss GMP QC labs product release testing is also undertaken according to GMP guidelines. Standard documents for our research products include Specifications and Certificates of Analysis (CoAs). Hit Chemics also offers fee-for-service QC testing from our wide range of analytical techniques. We can perform additional analytical tests on products from our catalog, or on any product that you need analyzed.
Techniques and Equipment
Our advanced laboratories and sophisticated equipment mean we can perform rapid, high quality analysis as part of our analytical services offering. From novel chromatographic methods to cutting-edge qNMR analysis and classical wet chemical methods, our expert analytical teams work with our customers to meet their needs.
The techniques we can perform includes determination of product identity and purity by
- Chromatography (HPLC, GC, TLC, IC)
- NMR
- FT-IR
- ICP-OES
- ICP-MS
- UV spectroscopy
- Specific rotation
- Elemental analysis
- Titration
- Determination of water content (Karl Fischer)
- Melting point
- pH value
- Loss on drying
- Sulfated ash
- Conductivity
- Refractive index
- TOC
We are pleased to have advanced NMR capabilities in all our sites across Europe and China, which allows the rapid analysis and consistency of products and methodology in our locations.
In addition to our expertise in physicochemical analysis of chemical substances, we operate a modern and well-equipped bio-laboratory where we can perform a range of biological assays and functional assessments. These include enzymatic activity, microbial growth performance tests, DNAse/RNAse and Endotoxin testing. Our experienced team is also able to develop novel bioassay methods as needed.
Where needed, we also offer management of third party providers, with measurements contracted out to qualified suppliers and overseen by us to complete your data package.
Method Development, Technical Transfer and Validation for GMP Products
As part of our analytical services, products can also be tested according to pharmacopeial methods or to our own established protocols. We are also happy to transfer in any other method provided to us and to discuss your needs and work closely with you to deliver your custom testing package.
By having teams in the UK and Switzerland working across discovery, optimization and development, we are used to performing technical transfers between sites, and work to mitigate risks in the transfer process and in method validation. We have extensive experience in the validation of HPLC, GC, KF and other methods, which have been developed alongside API manufacturing and GMP process development.
Stability Testing
Hit Chemics offer stability programs for GMP products according to ICH guidelines for shelf-life assessment as part of the GMP documentation package. We currently offer a range of conditions and will work with you in determining a suitable protocol.
Peptide Analysis
To find out more about the techniques and services of analysis of our peptide products, visit our dedicated peptide analytics page.
Analysis of Biomolecules and Bioconjugates
Within our offering of Bioconjugation services, we can perform analysis of biomolecules and bioconjugates. To find out more about the techniques and services visit our dedicated analytics page.