Method Development, Testing, And Validation
Source: Keata Pharma Inc.
Analytical Method Development, Validation, Stability and Contract Analytical Testing Services
Keata's Analytical and Microbiological Laboratories provide the following services on manufactured products:
- Analytical Method Development, Optimization, and Validation according to the ICH Guidelines
- Raw material, packaging component, chemical intermediate and finished product testing services:
- Analytical capabilities include: HPLC, GC, TLC, dissolution, UV-Vis, IR and many more
- Wet chemical analysis
- Compendia testing such as USP, EP and JP requirements
- USP dissolution testing
- Microbiological testing of pharmaceutical, biotech, nutraceutical, natural health, and consumer products:
- Microbial limits testing to meet USP and EP requirements
- Preservative effectiveness testing
- Cleaning validation and environmental monitoring
- Potable and purified water testing
- Sterility testing
- Atomic absorption
- Stability testing required to support finished packaged and bulk product stability programs:
- Stability studies and testing as per ICH guidelines
- Full stability data evaluation, including statistical evaluation of quantitative data
- Report writing and data compilation for technical progress reporting, GMP reviews and for submission-ready regulatory reports and modules
- Consulting on stability requirements for product development and post approval changes and variations