Over the last 25 years LEF’s acquired experience in the analytical field, allied to a continuous investment in state of the art technology, has allowed our company to offer differentiated and high-quality services, in the development and validation of analytical methods for finished and intermediate products, APIs and excipients.
We develop and validate proprietary and non-proprietary analytical methods following the on-going regulatory demands such as ICH Q2, ICH Q6A and ICHQ6B. We guarantee the transfer of analytical methodology fulfilling of all the EU-GMP Chapter 6 requirements, through the implementation of the most appropriate approach which can encompass comparative testing, co-validation with the client or re-validation.
LEF has available many analytical methodologies which include HPLC, GC, UV-VIS, IV, LC-MS/MS, dissolution, titration, TOC and ICP-MS.
Analytical development and validation services available:
- Identification and quantification of active pharmaceutical ingredients;
- Identification and quantification of impurities and related substances;
- Identification and quantification of residual solvents;
- Identification and qualification of preservatives, antioxidants and colouring substances;
- Dissolution assay;
- Residues quantification (API, Detergent) under the cleaning validation scope;
- Support assays under the process and cleaning validation scope.
Recently, LEF has invested in building a new laboratory with last generation equipment, which is dedicated to ICP-MS analysis. This investment puts LEF at the forefront of analytical innovation in determining Elemental Impurities and contaminant metals.
- Development and validation of ICP-MS methods;
- Elemental Impurities quantification (ICH Q3D, USP <232> and <233>, EP (5:20) and (2.4.20);
- Determination of Contaminant Metals concentration (Finished Product, Food Supplements and Food Substances).