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At CoreRx™, our services center on small molecule analysis - including preformulation, method development and qualification, drug substance and product release, and stability testing.
- Experimental design and
execution for separation, isolation, and analysis
of pharmaceutical compounds
- HPLC method development and validation for assay,
related substance, and dissolution
- Standard protocol for all development studies
- GMP stability studies
- Method development and validation for identity,
potency, quality, and purity of drug substances and
products
- Impurity profiles
- Photostability determination
- Specification testing
- Stability indicating assays
- Full document traceability
- Cleaning validation
- Specification development
- Stability testing via ICH guidelines
- Forced degradation studies
- Stability testing via ICH guidelines
- Forced degradation studies
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