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.
|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|
|Quality control and microbiology laboratories|
|Thermal cycling studies|
|Verification of USP methods|
|Whole and split tablet studies|