Formulation analysis for Safety Testing plays a vital role in regulatory compliance, ensuring that substances are accurately weighted in a vehicle, stable over time, and homogeneously mixed.
Ensuring dosage consistency, stability, and homogeneity
Key formulation analysis services
- Concentration Determination → Verifies the test substance concentration in formulations for accurate dosing.
- Stability Testing → Assesses the dosage stability of the test substance over the administration period and under conservation conditions.
- Homogeneity Assessment → Ensures uniform distribution of the test substance within vehicles.
GenEvolutioN utilizes chromatography techniques (HPLC and GC) to provide precise, GLP-compliant formulation analysis for in vitro safety testing
Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals
The ICH M7 guideline provides a framework for evaluating the potential mutagenicity of impurities in drug substances and drug products, ensuring that the safety of pharmaceuticals is maintained.
Key Genotoxic Impurities Management services
- Impurities evaluation → Analytical determination of impurities generated during the synthesis and storage
- Risk assessment – toxicological evaluation using in silico approaches (QSAR) and in vitro approaches (AMES)
- Control strategy → Testing for impurities in Drug Substances and Drug Products
GenEvolutioN utilizes advanced chromatography techniques (UPLC-MS/MS, UPLC-HRMS and GC-MS) to ensure that the safety of pharmaceuticals is maintained.
Assessing chemical leaching risks from packaging materials
Understanding how product interact with packaging materials is essential for consumer safety and regulatory compliance. GenEvolutioN conducts Extractible and Leachable studies to evaluate the release of chemicals from materials into pharmaceutical products and Migration studies to evaluate migration of chemicals from packaging into the food products.
Key study approaches
- Extractible Studies → Determines the potential for chemical to be extractable when a material is exposed to solvents and evaluate the genotoxicity of identified extractables
- Leachable Studies → Evaluates the transfer of chemicals into pharmaceutical products over the shelf-life.
- Migration Studies -> Assess the transfer of chemicals from food packaging into a food simulant using migration cells
By simulating real-world conditions, GenEvolutioN ensures that materials used in packaging, comply with safety standards such as FDA, EMA and EFSA.
Ensuring Medical devices material safety & regulatory compliance
Chemical characterization is essential for the biocompatibility evaluation of medical devices.
Key chemical characterization services
- Degradation and Residual Products testing → Identifies and quantifies degradation products form materials (ISO 10993-13, 14, 15) and evaluates levels of Ethylene Oxide Sterilisation Residuals (ISO 10993-7)
- Extractables & Leachables Studies → Assesses chemical release in typical and extreme use conditions (ISO 10993-17 & 10993-18).
- Risk Assessment & Toxicological Profiling → Evaluates potential health impacts to ensure regulatory compliance.
By applying ISO 10993 standards, GenEvolutioN ensures that materials meet global regulatory expectations and provide safe, high-quality solutions for patients.
