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
Analytical Problem Solving and 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
A wide range of spectroscopic determinations are available by means of Infrared (IR) and Nuclear magnetic Resonance (NMR). NMR instruments up to 600MHz are used associated to a variety of NMR probes (including high sensitivity cryo-probes) for applications which cover from simple Proton NMR acquisition up to full packages of 1D and 2D experiments and spectra interpretation. Among the available methods we offer are:
- Variable temperature experiments
- Heteronuclear NMR (19F, 51P, 11B etc)
- Stereochemistry determination
- Enantiomeric determination
- Quantitative NMR
- Ligand-target interaction studies
- Host-guest interactions in solution
- Self association in solution
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, peptide mapping and sequencing services. In addition, our staff have 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 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