Chemical
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Pre-formulation
(drug substance and excipient physical/chemical characterization)
- Drug Property Prediction
- Solubility
- pH-rate
- pKa
- DSC – USP <891>
- TGA – USP <891>
- XRD – USP <941>
- Dynamic Vapor Sorption
- Microscopy – Optical, Raman
- Particle Size Analysis
- Laser Diffraction (Mastersizer)
- PCS/DLS/QELS (Zetasizer)
- Solid State Stability
- Forced Degradation
Formulation
- Suspensions/emulsions – Polytron
- Capsules – manual filling
- Small-scale mixing / granulating
Enhanced Performance Formulations
- Lipid-based formulations
- Nano-suspensions
Analytical Analysis
- High Performance Liquid Chromatography (HPLC) – USP <621>
- Mass Spectrometry – USP <736>
- NMR – USP <761>
- FTIR – USP <197>
- Dissolution – USP <711>
- Chiral Analysis – USP <781>
- Endotoxin Content – USP <85>
- Osmolality – USP <785>
- Water by KF Titration – USP <921>
- Residual Solvents – USP <467>
- Particulates – USP <788>, <789>
- Trace Metals – USP <232>, <233>
Stability
- 40°C/75%RH
- 25ºC/60%RH
- 2C-8C (5C)
- -20C
- Photostability – ICH-Q1B-Option2
- 50ºC-80ºC (Stress Testing)
Microbiological Assessments
- Non-sterile Products – USP <1111>, <61>, <62>
- Sterile Products – USP <71>