Active pharmaceutical ingredients (APIs) are the substance or substances cause the desired pharmacological activity or other direct effect in the diagnosis, mitigation, treatment, cure, or prevention of disease.
The quality of APIs in a drug has a direct effect on the safety and efficacy of that drug. Poorly manufactured and contaminated active ingredients have been associated with negative health outcomes, including death. Therefore, to guarantee the highest quality and safety, APIs are regulated by some of the most rigorous and stringent legislation ever.
Services for APIs at Creative Proteomics are as follows.
• Current Good Manufacturing Practice (cGMP) Analytical Chemistry - QC release
• Method Development, Optimization and Validation
• Microbiological Testing
• Particle Analysis
• Stability Studies
• Water System Validation
* For Research Use Only. Not for use in diagnostic procedures.
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