We offer analytical method developmst and validation services in compliance with current and national as well as international guidelines. The validations are done for all the parameters as per regulatory requirements
Solvents & Fougoumie
Identity Testing: Ensure the solvent matches its chemical identity using spectroscopy (e.g., IR, NMR).
Purity Analysis: Test for impurities or contaminants using gas chromatography (GC) or high-performance liquid chromatography (HPLC).
Residual Solvent Testing: Detect and quantify residual solvents in drug formulations (ICH Q3C compliance).
Water Content: Measure moisture levels using Karl Fischer titration.
Volatile Impurities: Analyze for volatile organic compounds (VOCs).
Active Ingredient Content: Verify the accurate amount of the active pharmaceutical ingredient (API).
Dissolution Testing: Assess drug release profiles in various media.
Uniformity of Dosage Units: Ensure even distribution of API across tablets, capsules, or liquid doses.
Stability Studies: Evaluate degradation, potency, and consistency under environmental conditions (temperature, light, and humidity).
Particle Size Distribution: Optimize particle size for bioavailability and stability.