Analytical Method Development

Throughout the development process, the R&D Analytical Laboratory is involved in assessing the physical and chemical characteristics of both the drug substance and the candidate drug product formulations. Mikart’s analytical team works hand in hand with the Formulators throughout the Pre-Formulation and Development stages to assure that the critical quality attributes of the API and product meet requirements.

Our R&D Analytical team develops and optimizes test methods, then validates them to assure that they are suitable for your product. The Quality Control laboratory participates in the validation work so that there are no surprises when the product is ready for commercialization. This unique approach minimizes potential future method transfer hurdles and assures that a reliable method is in place for your product.

Services Offered:

  • Analytical Method Development and Validation
  • Method Transfer
  • Verification of USP Methods
  • DEA Schedule I-V Materials
  • Cleaning Validation Studies
  • Whole and Split Tablet Studies
  • Thermal Cycling Studies
  • Drug Release Profiles (Apparatus I and II)
  • HPLC, UPLC, AA, FTIR, UV-Vis, and much more
  • Quality Control and Microbiology Laboratories
  • Extensive Contract Resources for Specialty Analyses