Process Insight Born Of 45 Years Of Experience

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