ANALYTICAL SERVICES

ANALYTICAL SERVICES

Using our newly built laboratories, we provide a wide range of analytical services to help support your team in compliance with ICH/FDA/EMA guidelines. Our facility is FDA registered and has full European GMP certification.

 

The analytical team supports our customers on a number of different projects including analytical method development and validation. We develop robust and rugged methods through:

  • Developing potency and purity methods;

  • Accuracy and recovery studies;

  • Precision (test/re-test reliability & intermediate precision)

  • Specificity & Selectivity

  • Limit of Detection (LOD)

  • Limit of Quantitation (LOQ)

  • Linearity & Range 

  • Stability of Analytical Solutions

  • Specificity

  • Robustness

 

We also provide analytical support services to transfer methods to third-party laboratories or contract manufacturing partners, ensuring a smooth transfer of knowledge.

 

Our analytical chemistry support is available as part of our drug development programs or on a stand-alone basis to help bolster your existing team.

Contact us today to see how the J. Molner team can help you solve your analytical chemistry challenges!

Check out the virtual tour of our GMP laboratory here.

KEY ANALYTICAL SERVICES

  • Method Development and Validation as per ICH/FDA/EMA guidelines

    • Assay (HPLC/GC)​

    • Impurities (HPLC/GC)

    • Dissolution/Drug Release (UV/HPLC/GC)

    • Residual Solvents (GC)

  • Raw Material & Product Release​

  • Stability Studies

    • Refrigerated​

    • Controlled Room Temperature Conditions

    • Intermediate Conditions

    • Accelerated Conditions

  • Degradation Studies

  • Physical & Chemical Characterization

  • API Analytical Profiling

  • Technical Consulting

  • Method Transfer

  • Pharmacopeial Method Verification

  • Cleaning Method Validation

  • In-Vitro Release Testing (IVRT) to support Topical Formulation development using Franz Cell technique

  • In-Vitro Release Testing (IVRT) to support Topical Formulation development using Immersion Cell technique

  • IVRT Comparative Studies between Innovator and Developed Product