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Pharmaceuticals

Accurate testing results with the rapid turnaround you expect. Impact Analytical provides testing support for pharmaceutical companies during preclinical, phase I, phase II, and phase III of the drug development process for both small and large molecule APIs and drug products. We assist our clients with pharmaceutical development, method development, validation, stability, formulation, batch release, and extractables/leachables.

Analytical testing during drug development is required and governed by the FDA. Although the FDA does not specify details of how the tests should be conducted, they do specify how they must be documented and the depth of testing that’s required. We are well versed in the FDA and regulatory guidelines to ensure your testing complies with your specific requirements. As a pharmaceutical manufacturer, it’s important for you to partner with a lab that has a quality system in place and can perform testing per cGMP, following 21 CFR guidelines spelled out by the FDA. To learn more about our rigorous quality system, please visit Impact Analytical Quality System.

Look to a partner who can quickly get you over the hurdles and safely to market in today’s global pharmaceutical industry.

Actives Quantitation

Clinical Release Testing

Elemental Impurities, USP <232>, <233>

Impurity Detected in Major Pharmaceuticals

LC-MS/MS

Raw Material Characterization

REACH Testing

Regulatory Testing

Residual Solvent Testing

Silicon Testing

USP <661>

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