Whether there is a requirement for full proof-of-structure and preformulation profiling, rapid identification of unknowns, detailed protein characterization, or simply sample analysis, we can effectively address the requirement.
Salt Screening and Preformulation
Aptuit offers a wide range of preformulation services designed to facilitate dosage form development and assist the development of drugs exhibiting inadequate solubility, stability, and/or polymorphic behavior. Our highly trained team of skilled scientists is focused on providing data critical to rapid drug development and can conduct the following:
- Salt screening/selection
- Polymorphism screening
- pH solubility profiling
- pKa determinations
- Partitioning
- Hygroscopicity
- Stability prediction and kinetic profiling
- Intrinsic dissolution
- Heats of solution/complexation
- Qualitative/quantitative determination of amorphous and/or polymorphic content in either API or drug product
Troubleshooting
We provide solutions tailored to address your challenges. Whether it is a question of explaining low assay results, identifying unknown chromatographic peaks, or isolating and characterizing unknown particulates, our scientists consistently provide clients with rapid, high quality solutions to encountered problems using a wide range of analytical technologies, including IC, ICP, FTIR, GCMS, LCMS, NMR, PLM, SSNMR, SEM-EDXS, and XRPD. If there’s a problem, we have a solution.
Spectroscopy
Elucidation of structure, reference standard characterization, identification of unknowns, development and validation of spectroscopic identity, and control methods are all readily available at Aptuit. With a broad range of closely aligned services, we provide a seamless interface for clients requiring anything from simple sample analysis to full drug development.
LCMS Services
Our highly capable LCMS department provides extensive large molecule support, including protein characterization, glycosylated peptide analysis, oligonucleotide ID and impurity profiling, and peptide mapping and sequencing services. In addition, our staff has the skill and experience necessary for the rapid identification of drug impurities and degradants for both large and small molecule drug development programs.
Mass Spectrometry
The mass spectrometry group at Aptuit provides a wide range of techniques to analyze, characterize, and identify small to large molecules. Utilizing a range of GC/MS, LCMS, LC/MS/MS, and TOF mass spectrometry instrumentation, we support stability studies, characterize biomolecules, identify impurities, and quantify small molecules
The mass spectrometry group at Aptuit provides:
- Method development and validation
- Impurity or degradation identification
- Structural elucidation of unknowns
- Peptide mapping and sequencing
- MS/MS and de novo sequencing
- Protein characterization
- Degradation pathways, disulfide bond, post translational modifications
- Lot-to-lot comparisons
- ARS characterization – accurate mass determination
- Quantitative and qualitative analysis
- Glycosylated peptide analysis
- Oligonucleotide ID and impurity profile
- Support to stability studies