At AustinPx, Pharmaceutics and Manufacturing, 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.
Chemical Analysis: UPLC/HPLC
- Assay, ID and Related Substances
- Stability-indicating Methods
- Detection Modes: UV/VIS
- 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
Phase Appropriate & Comprehensive
AustinPx employs a phase-appropriate approach to analytics. Realizing the importance of a stability-indicating method, we utilize forced degradation studies in the earliest phase of development. Method parameters are then optimized to improve resolution and recovery of the product-related impurities. As part of method development, key performance criteria such as specificity for degradation products, linearity, precision, system suitability, etc. are evaluated. These development data serve as range-finding tools for subsequent protocol-driven qualification and validation studies.
Our labs also perform chemical and physical stability assessments of drug substances, drug product intermediate and finished dose forms. In the early phases, AustinPx QC typically performs qualification of non-compendial product specific methods to demonstrate their suitability for use in release and stability testing. As you move towards late phase clinical and commercialization, we recommend full method validation for utilization with process validation, conformance lot testing and use in testing drug substance and drug product.
Our QC lab ensures that raw materials used in GMP manufacturing, as well as intermediates and dosage forms manufactured at AustinPx meet applicable quality standards.
If you have any questions about our technologies, capabilities, or want to schedule an introductory discussion, contact us.