Our laboratories, equipped with the most modern instrumentation including UPLC, HPLC, LCMS, LC-MS/MS, LC-TOF-HRMS, GC, GC-MS and dissolution systems is operated by a well trained and highly motivated staff with an average of over 10 years of practical experience. The Pharmaceutical Analytical Laboratory is GMP inspected and under control of the respective authorities. |
We deliver analytical services on: Active Pharmaceutical Ingredients (API) Raw materials Excipients Solid formulations Liquid formulations (solutions, suspensions, injectables) Semi-solid formulations (gels, creams, ointments, suppositories)
Our services include but are not limited to: Analysis according to official monographs (PhEur, USP, AOCS) Method development/implementation/optimization & validation Stability studies Cleaning method development and validation Forced degradation studies Impurity profiles Structural Elucidation of Unknowns Reference Standard Characterization Solubility studies Respons factor studies Extractable/Leachables Residual solvent analysis Batch control Release analysis Process support Container closure integrity testing Dissolution and disintergration Technology Transfer to QA at Contract Manufacturing partner QP- Qualified person service Patent Infridgement – Analytical support FDA Dietary Supplements Consulting
|
 |