Demonstrating that every method is fit for purpose
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. Pharmatek’s chemists focus on developing, qualifying and validating methods or refining existing analytical methods to meet these demands. Pharmatek offers most modes of detection including, UV/VIS, PDA/DAD, size exclusion and has developed particular expertise in Evaporative Light Scattering Detection (ELSD) which can address compounds that lack a UV chromophore.
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Analytical Development & Validation Services
Analytical methods development and validation play important roles in the development and manufacture of pharmaceuticals. We provide analytical chemistry and quality control support for Method Development and Validation in accordance with ICH guidance documents and current Good Manufacturing Practices. With extensive method development and validation experience we offer:
- API and Drug Product methods
- Stability indicating methods
- State of the art technology such as UPLC decreasing run time while increasing sensitivity
- Compliance with ICH under cGMP quality
- API, raw materials and Drug Product testing and release
- API and Drug Product stability testing
- Accelerated stability studies
- Identity, quantitation, potency, content uniformity
- Process contaminants, excipients, impurities, degradants
- Lot release and stability assessment
The Pharmatek Difference
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.