At AustinPx we believe analytical data is foundational to drug development, even in the earliest phases. As a pharmaceutics and manufacturing company, we believe our ability to generate and interpret analytical data directly contributes to successful formulation and dose form design. In our analytical development lab, we deploy a variety of techniques to assess the physical properties of drug substances, prototype formulations, drug product intermediates and finished dose forms.
AustinPx maintains two well-equipped analytical facilities: a development laboratory and a GMP Quality Control laboratory. AustinPx’s chemists work to develop, qualify, and validate methods or optimize existing analytical methods to meet these demands.
Capabilities Include:
- Chemical Analysis: UPLC/HPLC
- Assay, ID and Related Substances
- Stability-indicating Methods
- Detection Modes: UV/VIS
- Dissolution/Flux
- USP Apparatus 1/2 Dissolution Systems
- Pion Rainbow and Spectra Systems for in-situ UV Analysis
- pH Dilution Shaker/Ultracentrifuge Systems
- Drug Product Test Methods: In-process and Final Release
- LoD, Karl Fischer, Dissolution, Disintegration
- Preclinical through Commercial: Qualification/Validation
- Release Testing and GMP Stability Studies