Inorganic Impurities are a critical quality attribute of drug substance and drug products because they have the potential to affect the safety and efficacy of the product. The regulatory and compendial standards for the control of impurities continue to evolve due to advancement in analytical science, technology and toxicology.The International Conference on Harmonisation guidelines defines impurity as any component of the drug substance that is not the chemical entity defined as the drug substance and affects the purity of the active ingredient.

The active pharmaceutical ingredient (API) is produced by organic chemical synthesis. In these processes components like residual solvents and the traces of inorganic and organic components can be generated. The remaining component in API is considered as impurities.

We specialize in the development of methods for –

Identification, Quantification and Control of Impurities

Pharmaceutical impurity testing, identification and quantification are vital to address the purity, safety and control over the quality of drug substances or finished drug products.

Sources of Inorganic Impurities

Pharmaceutical inorganic impurities can arise from several sources which include initial materials and their contaminants, reagents, catalysts, solvents, intermediates, excipients and their contaminants, leachable and degradation products. They can be organic impurities, process and drug-related, inorganic or elemental impurities.