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Pharmaceutical Testing and
Raw Material Characterization
Pharmaceutical Testing and Material Characterization
The ability to characterize pharmaceutical products and identify any unknown component or impurity is crucial for product development and release. The presence of an unknown or impurity even at trace levels might render the material unusable depending on the product application and toxicological properties. Unknowns and impurities can come from several sources and require various techniques to identify. Element labs like Impact Analytical offer full analytical capabilities to assist in testing at all stages of drug development including:
- Pharmaceutical discovery and development including formulation
- Method validation
- Stability storage and testing
- Lot testing for QC release
- Extractable and Leachable
- Small batch manufacturing for Phase I clinical studies
- Container testing
For clients needing cGMP testing it is important to partner with a lab that has the proper quality system in place and understands the regulatory guidelines in 21 CFR for US, FDA testing. Also, Impact’s quality systems and procedures are compliant with other regulatory bodies such as Health Canada.
Techniques used for the process
Going beyond the commonly used techniques to characterize active pharmaceutical ingredients (APIs) such as LC-MS, GC-MS and ICP-MS, Impact Analytical specialize in techniques such as:
- Scanning Electron Microscopy with EDS Detection
- Imaging of conductive and non-conductive samples
- Elemental Analysis
- Contamination Analysis
- Glass Delamination studies -USP<1660>
- Particle Size Distribution
- Powders, suspensions and emulsions
- Method development, validation and routine testing
- Xray Diffraction (XRD)
- ID and quantification of APIs
- Identification of crystalline form of API
- ID of crystalline unknown samples
- Testing to USP <941> and other monographs
If you are looking for a partner to quickly and reliably clear your testing hurdles, regardless of the developmental stage of your pharmaceutical material, our team can help. Contact us.
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