Analytical Development & Services
Advanced Analytical Services
In addition to our standard solid-state characterization techniques employed to locate the most suitable API solid form, we offer the possibility of obtaining more advanced physchem data by employing techniques such as:
- Single Crystal X-ray Diffractometry (SC-XRD)
- Particle Size Distribution
- Solid State Nuclear Magnetic Resonance (SS-NMR)
- High Performance Chromatography – Mass Spectrometry (HPLC-MS), and more others
SARA Pharm Solutions scientists with considerable research experience have a deep understanding of all these techniques being able to provide clear and concise data interpretation.
Solvation/Hydration (Phase Transition) Studies
As integrated part of solid-state analytical services, SARA Pharm Solutions offers the possibility to investigate the (de)-solvation and (de)-hydration processes of an API.
These processes are studied by XRPD, PLM, DSC, TGA, and DVS, while new anhydrous crystalline forms (new polymorphs) of high thermodynamic stability, may be located.
Our scientists establish the relationship between the identified anhydrous forms, aiming to locate the most suitable solid form for development.
Solving Crystal Structures
At SARA Pharm Solutions we offer two distinct packages for crystal structure determination, consisting of:
- single crystal analysis; we can grow a SC sample or take in for analysis your SC sample
- analysis of powder data; our scientists use computational tools associated with high quality XRPD data.
This analysis includes indexing and space group determination, intensity extraction, model(s) generation, crystal structure solving and refinement.
In this last particular case, we use of a high-resolution (HR)-XRPD instrument.
Advanced characterization techniques such as (both 1 H- and 13 C-) NMR and HPLC are employed for the investigation of drug purity.
This standard service is offered as stand-alone or integrated part of the full developability assessment package. Analysis of standard reference samples (such as known drug impurity references) are considered upon customer request. With this purpose, an HPLC method can be developed and validated in our labs.