Crystallization
The properties of a crystalline compound are significantly different from that of an amorphous one and it is vital to also perform the early phase investigation on the representative form to avoid serious misinterpretations. Crystallization development and scale-up is always a challenge since the product properties must meet up to the intended functionality, stability, and safety of the final product. Our teams have more than 30 years of experience in the field and are leading experts in the area.
API solid form
Our team of experts is highly experienced in supporting well-designed crystallization processes and supporting your product development, by providing deeper insight into the solid-state properties of your drug substance and helping you to ensure high product purity and the consistent delivery of the desired crystal modification.
Since the particle size distribution of the product depends upon both the solvent/solute system used and process parameters and equipment properties, crystallization can be employed to engineer particles precisely and with the right properties that ensure the optimum performance of the drug product. By applying our practical know-how, theoretical understanding and innovative technical approaches, we provide direct support in this area. Integrated into our small-scale approach is not only traditional solvent based methodology but we also perform complementary investigations, based on alternative technologies, and thus significantly increase the success rate of providing you with seeds or a manufacturing protocol.
Capabilities
| DSC / MDSC |
| TGA |
| XRPD |
| IR (microscopy possibility) |
| Raman (microscopy) LALLS (Malvern 3000, Malvern Mastersizer) |
| BET |
| Powder flow |
| Pycnometer |
| GVS |
| TAM (microcalorimetry) Isothermal or Scanning |
| SEM |
| EDS-SEM |
| LM |
| NMR |
| SXRD |
| Reverse engineering |
| Micronization |
| Micro mixing |
| Crystallinity |
| Amorphicity |
| Salt and polymorph screening and selection |
| Crystallization of “difficult-to-crystallize” compounds |
In addition, we also perform a broad range of tailor-made investigation services related to material characterization, understanding, troubleshooting and synthesis of gram and kilo quantities.
Talk to one of our specialists
Thomas Larsson
Thomas has 30 years of experience from working within global pharmaceutical industry. He is expert in solid state characterization of pharmaceutical APIs and formulations and is Solid State Manager within Magle Chemoswed AB since 2019.
