Your needs: analyse the composition of your products using a validated analysis method based on the international ICH Q2 standard
Why validate an analysis method according to the ICH Q2 standard?
The ICH Q2 (R2) international guideline provides a reliable framework for the validation of analytical procedures. It ensures that the analytical technique used is suitable for its intended purpose, whether for identifying active pharmaceutical ingredients (APIs), testing for impurities, or quantifying impurities.
Validation is mandatory for regulatory submissions (CTD Module 3) and ensures the safety and efficacy of drug products. Modern revisions now include principles for spectroscopic data (FTIR, Raman, NMR, MS) and multivariate statistical analysis.
Comprehensive validation parameters
As a specialized ICH Q2 laboratory, FILAB performs full validation protocols covering the core requirements of the guideline:
- Specificity & selectivity: ensuring the method can unequivocally assess the analyte in the presence of components like excipients or impurities.
- Accuracy & linearity: demonstrating that results are directly proportional to the concentration of the analyte.
- Precision: evaluating repeatability (intra-assay), intermediate precision, and reproducibility.
- Detection (LoD) & quantitation (LoQ) limits: essential for trace analysis and impurity profiling.
- Robustness: testing the method's capacity to remain unaffected by small variations in method parameters.
Our solutions: provide you with our expertise in validating analytical methods in accordance with the ICH Q2 guideline
Our laboratory analysis services
FILAB combines over 30 years of experience with state-of-the-art 5,200 m² facilities to support your pharmaceutical development. Our services include:
- Analytical method development: tailored methods for complex matrices.
- Method transfer: seamlessly transitioning methods between laboratories.
- Impurity profiling: compliance with ICH Q3C (residual solvents), ICH Q3D (elemental impurities), and nitrosamine testing.
- Biopharmaceutical characterization: specialized analysis for peptides and oligonucleotides.
Advanced instrumentation for ICH Q2 validation
Our ICH Q2 laboratory utilizes high-performance technology to ensure the highest sensitivity:
- Chromatography: HPLC, GC-MS/MS, LC-MS/MS, and GPC/SEC.
- Elemental Analysis: ICP-MS and ICP-AES for trace metal detection.
- Structural Analysis: NMR, FTIR, and Raman spectroscopy.
Why FILAB ?
As an independent laboratory with a team of experienced doctors and engineers, FILAB guarantees the reliability of its results, rapid response to requests and personalised support for its customers.
Our FAQ
An ICH Q2 laboratory, like FILAB, specializes in verifying that analytical procedures used for pharmaceutical testing are accurate, reliable, and reproducible. This is a critical requirement for FDA, EMA, and other regulatory body approvals.
Yes. FILAB offers complete validation services including specificity, accuracy, linearity, range, and robustness studies tailored to meet international regulatory requirements.
Validation is required for APIs, excipients, finished drug products, and biopharmaceuticals such as therapeutic peptides and oligonucleotides.
Absolutely. Our laboratory routinely develops and validates methods for complex biological samples, including peptide mapping and impurity profiling for biotherapeutics.
To obtain a quote, you can contact our team via our contact form, by phone, or by email.
Simply tell us your requirements (type of material, desired analysis, applicable standards, urgency, quantity of samples, etc.). We will then send you a personalized technical and pricing proposal within 24-48 hours.
Turnaround times vary depending on the nature of the analysis and the complexity of the expert assessment project.
However, FILAB is committed to providing fast turnaround times tailored to your industrial constraints and urgent needs.
