Assay & Related substances test for Raw materials, excipients and Finished products
Multimedia dissolution studies
Titration: Volumetric analysis for acid-base, non-aqueous, or redox determinations of purity.
Spectrophotometry (UV-Vis / FTIR): Measuring light absorbance or infrared spectra for identification and quantitative assay.
Related Substances / Impurity Profiling: Detecting and quantifying organic and inorganic impurities introduced during synthesis or storage.
Residual Solvents Testing: Analyzing volatile organic chemical residues left over from manufacturing .
Heavy Metals & Elemental Impurities: Screening for toxic elements (e.g., lead, cadmium, arsenic, mercury) using ICP-MS or atomic absorption.
Related Substances / Impurity Profiling: Detecting and quantifying organic and inorganic impurities introduced during synthesis or storage.
Residual Solvents Testing: Analyzing volatile organic chemical residues left over from manufacturing (typically via Gas Chromatography per USP <467>).
Extractables & Leachables Testing
Analytical Method Validation: Proving that test procedures are specific, linear, accurate, precise, and robust in compliance with pharmacopeial standards (USP, EP, IP, JP) and ICH guidelines
