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Specialties and Technologies
For nearly twenty years, Boston Analytical has been providing superior testing and analysis to Pharmaceutical, Biotech, Cosmetic, Medical Device and Nutritional product companies worldwide. We assist these companies in the areas of Product Development, Release and Stability Testing. Recent additions to our specialty services include Microbial Identification via Comparative DNA Sequencing Technology and Environmental Monitoring.
Core Services
All of our services are performed by highly educated chemists in our
state-of-the-art analytical laboratories, and all work is ensured to be of the highest
quality -- audited 100 percent for compliance to FDA cGMPs (Current Good
Manufacturing Practices), specific client requirements and our own S.O.P (Standard
Operating Procedures).
Our Technologies Include
- Method Development & Validation per ICH / FDA
- Automated Dissolution / Disintegration Testing
- Stability Studies and Storage per ICH
- Photostability per ICH Option II
- Microbiology Services - USP / EP / JP
- Microbial ID via DNA Sequencing & MicroSeq®
- Antimicrobial Effectiveness Testing <51>
- Microbial Limits Testing <61>
- Sterility Testing <71>
- Bacterial Endotoxin Testing - LAL <85>
- Particle Size Testing <788>
- Water for Pharmaceutical Purposes <1231>
- Environmental Monitoring and Supplies
- Viable and Non-Viable Air Monitoring
- Cleaning Validations / Total Organic Carbon
- HPLC / GC, AA, UV-Vis, FT-IR, Fluorescence, ELSD and TLC
- Polarimetry
- Viscosity
- Consulting Services
You make a great product... Let us prove it!
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