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Our Specialized Pharma Product Testing Services include but are not limited to-
Method Establishment
- Method Development and Validation
- Method Transfer
Trace Analysis
- Nitrosamines
- Test all seven FDA identified drug product impurities
- Genotoxic impurity
- Detect genotoxic impurities regardless of mechanism using GC-MS/ LC-MS
- Residual Solvents
- Get accurate levels of organic volatile chemicals that are used or produced in the manufacture of drug substance or excipients or in the preparation of drug products
- Elemental Analysis
- Trace metal analysis using ICP-MS. Trace and ultra-trace elements at part per billion (ppb) levels
Quality Control
- Batch Release Test
- Raw Material & Excipients
- Packaging Testing
Physical Characterization
- Particle Size Distribution -
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