Reliable and reproducible analytical methods are essential to both the pharmaceutical development process and the evaluation of drug product to meet the standard of potency, purity and stability. Analytical chemists will work to develop, qualify and validate methods or refine existing analytical methods to meet these demands. Pharmatek offers most modes of detection including, UV/VIS, PDA/DAD, RI, Fluorescence and Conductivity detection and has developed particular expertise in Evaporative Light Scattering Detection (ELSD) which can address compounds that lack a UV chromophore.
Analytical Services For Solid Oral Dosage Forms:
- Analytical services
- Methods development and validation
- Identity, quantitation, potency, content uniformity
- Process contaminants, excipients, impurities, degradants
- Lot release and stability assessment
Analytical Services Specifically For Injectable Drug Product
- Stability indicating HPLC method development & qualifications (Reversed Phase, Ion Exhange)
- Accelerated stability studies
- In-use stability studies
- pH solubility & stability assessment
Ultimately, the success of a drug candidate relies not only on its clinical merit but also on the ability of the sponsor to provide data supporting the regulatory requirements of stability, potency and purity. Analytical assays are the foundation of this assessment and the anchor to all ongoing drug development efforts. At Pharmatek, the focus on analytical excellence leads to the development of methods that are robust and easily transferable.