We employ our powerful analytical method development capabilities to determine the solid form(s) of the active drug in formulations and the stability of the drug product and formulation. Most structural changes produced in the formulation process or occurring during storage can be detected and eliminated and the process improved. This is crucial when troubleshooting problems with dosage forms. We routinely develop full quantitative and limit test assays under cGMP to monitor the solid form in drug substances and drug products. We also issue certificates of analysis for lot release on both the drug product and drug substance. We are a leader in developing and analyzing amorphous formulations for enhanced solubility.
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- Drug Discovery Solutions
- Drug Development Solutions
- Analytical Services
- Analytical Method Development and Validation
- Analytical Testing Services
- Sample Submission and Forms
- Biopharmaceutical Analysis
- Chromatography
- Diffraction Studies
- Gas Testing
- Heavy Metals Testing
- Biochemistry Services
- Initial Drug Substance Characterization
- Mass Spectrometry
- Material Testing
- Microbiology
- Micromeritics
- Microscopy
- Personal Care Chemistry
- Residual Solvents
- Sorption and Desorption
- Spectroscopy
- Structural Characterization
- Thermal Analysis and Calorimetry
- Water Analysis
- Glass Delamination – USP 1660
- Unknown Particulate Identification
- Particle Characterization
- Batch Release and Stability Lot Testing
- Solid-State Chemistry and Particle Engineering
- Drug Product and Delivery
- Extractables and Leachables
- Container Closure Integrity
- Container Qualification
- Packaging and Distribution Testing
- ASTM & ISTA Distribution
- Environmental Conditioning, Cycling and Simulation Testing
- Pharmaceutical Package Testing
- Medical Device Packaging Testing
- Consumer Product Packaging
- Shelf Life and Accelerated Aging Testing
- Packaging Materials Testing
- Package Labeling
- Package Strength
- Package Integrity
- Retains and Complaint Resolution
- Environmental Conditioning
- ISTA 6 Amazon Testing
- Medical Device Testing
- Microbiological Laboratory
- Problem Solving
- API Development and Manufacturing Solutions
- Drug Product Solutions
- Government Contracting
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