The experience acquired over the last 30 years in the analytical area, as well as the investment in state-of-the-art technology, allows LEF to provide its customers with high quality and differentiating service, in the development and validation of methods for the analysis of the final product, product intermediate, APIs and excipients.
We develop and validate methods from scratch as well as validate existing methods in accordance with current ICH Q2 regulatory requirements and in line with ICHQ6A and Q6B. We ensure the transfer of analytical methodology to our clients, fulfilling the requirements of EU-GMP Chapter 6 and using different approaches, which may involve comparative tests, co-validation with the client, or revalidation.
We have several analytical methodologies, namely HPLC, GC, UV-VIS, IR, dissolution, titration, TOC, and ICP-MS.
We develop and validate analytical methods:
- Identification and quantification of active substances (including stability indicator methods)
- Identification and quantification of impurities and related substances (including carrying out stress studies)
- Identification and quantification of residual solvents
- Identification and quantification of preservatives, antioxidants, and dyes
- Dissolution test
- Quantification of waste (API, Detergent) within the scope of cleaning validation
- Carrying out tests to support process validation and cleaning validation
In 2018, we built a laboratory dedicated to the analysis of ICP-MS, with state-of-the-art equipment, which allows us to be at the forefront of the determination of elemental impurities and contaminating metals.
Analysis by ICP-MS:
- Development and validation of methods by ICP-MS;
- Determination of the level of Elementary Impurities (ICH Q3D, USP <232> and <233>, EP (5:20) and (2.4.20);
- Determination of the concentration of Contaminant Metals (Medicines, Food Supplements, Foodstuffs, and packaging materials).
We also support activities of:
- Characterization and performance evaluation of semi-solid formulations through IVRT studies (in vitro release tests), using vertical diffusion cells (Franz type)
- Skin pharmacokinetic evaluation in semi-solid formulations through IVPT studies (in vitro permeation tests), using vertical diffusion cells (Franz type) and human skin (stratum corneum and viable epidermis)
Both tests are carried out in the GMP scope.