Impurities are normally generated during the formation of Active Pharmaceutical Ingredients and their intermediates. Chances of their generation during Drug Products formation are less as formulation is a physical blending process. Care is taken that these excipients do not react with each other to produce the degradants. They may consist of organic and inorganic, and define levels at which impurities/degradants should be identified.

ICH Q3A covers drug substances and Q3B covers drug products. These guidelines define what investigations and documentation should be made in investigating impurities and degradation products seen in stability studies at recommended storage conditions. Based on the data generated their specification can be arrived at. Depending on their amount the qualification, if required is carried out.

Impurity synthesis involves three steps: Detection, Modes of Formation, Synthesis and Structure elucidation by using various techniques. Determination of Purity of Impurity is mandatory otherwise its quantification in the API and Drug products can be challenged.

Pharmaffiliates can identify the structure of unknown impurities/degradants in active pharmaceutical ingredients, intermediates, or Drug products. We use state-of-art instruments to isolate, analyze and identify impurities. Instruments used include NMR, LC/NMR, FTIR, LC/MS/MS and GC/MS.

A complete package containing characterization for each impurity/degradation product is made available for supporting the Dossiers.