Method Development & Validation

Method Development & Validation 2018-05-10T07:13:22+00:00

Method Development & Validation, Method Verification, and Method Transfer.

Whitehouse Labs is a contract research lab that has the resources and flexibility to develop analytical methods or improve existing ones to tailor to your specific needs. Our laboratory team has extensive experience in designing and executing method development and validation protocols, Method Verification protocols and Method Transfer protocol. Our knowledgeable and experienced scientists develop methods using a wide range of analytical techniques. Analytical methods developed include procedures for active pharmaceutical ingredients (APIs), drug formulations, cosmetics, personal care products, and raw materials.

Method Development and Validation services for clients are governed by a contract. Each of these activities, when related to client specific needs, will be developed in house utilizing the client’s expertise about the product and Whitehouse Labs testing expertise.

All Method Development and Validation, Method Verification, and Method Transfer services will be:

  • All of our work is performed under strict compliance with cGMP requirements, and our analytical operations are based on formal written, detailed SOPs and stringent quality assurance practices.
  • Carried out by qualified personnel equipped with adequate resources.
  • Handled by utilizing a protocol or plan agreed upon by both the client and by Whitehouse Labs.
  • Communicated effectively and efficiently between Whitehouse Labs and Clients.
  • Upon completion, detailed procedures are summarized in a final comprehensive report that will be signed off by both the client and Whitehouse Labs.
  • Our standard report format includes a copy of the analytical method, a copy of the protocols, all test results, appropriate graphs and calculations, and sample raw data (ie…GC/HPLC chromatograms).

Analytical Techniques uses:

  1. HPLC: UV variable wavelength, Refractive Index (RI), Photo diode array detectors
  2. GC: Flame ionization detector (FID), Thermal conductivity detector (TCD), direct injection, and headspace analysis.
  3. GC/MS: identification of chemical structure and molecular weight determination based on the library of compounds.
  4. Atomic Absorption Spectrophotometry (Flame)
  5. UV/Visible Spectroscopy
  6. ICP-MS

Typical Analytical Characteristics Used in Method Validation, and Method Verification:

  • Accuracy, Precision, Specificity, LOD/LOQ, Linearity, Range, and Robustness.