Tergus has been providing analytical expertise and laboratory services for several years now. We can provide analytical method development, validation and testing for your topical and specialty semi-solid dosage form. Our scientists have expertise in analyzing complex semi-solid matrices to support development, informal and ICH stability studies, and release of clinical trial material.
Our Analytical Services Include:
- Analytical method development, validation and testing
- Cleaning validation
- Batch/lot release testing for APIs and formulated drug products
- Stability testing (to support formulation development, preclinical, clinical and ANDA activities)
- USP testing
Tergus has several equipment in place for the testing and analysis of semi-solid products. The lab capabilities continue to grow with customer and business needs.
- HPLC (High Performance Liquid Chromatography)
- UV-Vis Spectroscopy
- FTIR (Fourier-transform Infrared Spectroscopy)
- TLC (Thin-layer Chromatography)
- Karl Fischer
- Texture Analyzer
- Dropping Point Apparatus
Our team works closely with each client to not only meet their specific needs in the most efficient way possible, but also strive to exceed those needs by anticipating obstacles and formulating solutions. The vast array of specialties encompassed in our services for topical products include method development and validation, as well as planning and execution of stability studies for both R&D and GMP purposes. We meticulously gather data throughout the analytical process to insure reliable and robust results for analytical release, validation and method development. We also have the capability to execute method transfers, refining the existing process to meet and/or exceed client needs.