Mikart’s analytical services begin with accurate measurements of formulation characteristics and are informed by our dedicated team’s mastery of process — the precise changes that maximize your product’s performance and market adoption.
Our R&D laboratory assesses the physical and chemical characteristics of both the drug substance and the candidate drug product formulations while our analytical team works hand-in-hand with formulators throughout the pre-formulation and development stages to ensure the critical quality attributes of the API and product meet requirements.
Test method development and optimization precede quality control lab validation — our sequential and rigorous methodology discovers, addresses, and eliminates potential commercial-scale production issues before they can occur.
Capabilities
| Analytical method development and analytical method validation |
| Cleaning validation studies |
| Contract resources for specialty analyses |
| DEA schedule I-V materials |
| Drug release profiles (apparatus I and II) |
| HPLC, UPLC, AA, FTIR, UV-Vis, and more |
| Method transfer |
| Quality control and microbiology laboratories |
| Thermal cycling studies |
| Verification of USP methods |
| Whole and split tablet studies |