GMP Pharmaceutical Product Testing The testing of your API or finished pharmaceutical product is far too important to entrust to a contract laboratory having a compliance record that is anything less than exceptional. That’s why companies of all sizes choose Eurofins AvTech Laboratories when they need to outsource GMP-compliant analysis of their pharmaceutical materials. They realize that our exemplary FDA compliance record, conservative philosophy, quality systems, and scientific excellence combine to provide peace of mind in knowing that their critical analyses will be done right the first time, and in a fully compliant manner. Whether you require us to analyze your product or material using your analytical method, a USP Monograph, or a method developed and validated by our method development experts, the results will be the same — the highest quality data available, on time, with no worries. Special Offerings - Consent Decree Support
- Expedited Sample Analysis
- Analysis of Controlled Substances
- DEA schedule II-V license
General Capabilities - Release Testing
- ICH Stability Storage & Stability Testing
- Testing of API & In-Process Materials
- Manufacturing Process Validation
- Cleaning Verification
Specific Expertise - Potency and Stability-indicating Assays
- Identification by FTIR, TLC and HPLC
- Release of Active Component
- USP dissolution testing
- Drug diffusion (creams & ointments)
- Single point & profile analysis
- Content Uniformity
- Residual Organic Solvents
- Karl Fischer Moisture
- Disintegration
- Tablet Friability & Hardness
- Microbiological Testing
Equipment & Systems- HPLC-UV, Fluorescence, Diode Array
- UV/Vis Spectrometry
- GC-FID, Head Space
- GC-MS
- USP Dissolution Apparatuses
- Franz Cell Diffusion Chambers
- FTIR Spectrometry
- Electrochemical Titration
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