Impurities can arise from different sources, but synthesis is the clearest source of impurities. Where by-products and intermediates can be taken as an impurity in the active pharmaceutical ingredients or they can result in the source of other impurities, every impurity in the initial material is likely to be the active ingredient of interest. Impurities which are associated with solvents and excipients used throughout synthesis should also be considered. Impurities can be produced during various pharmaceutical product manufacturing phases. During different drug product formulation steps, Impurities can be produced. These impurities are likely to be there in the final drug product.
The impurities attributed inert ingredients or drug substance used in the formulation of the drug product, They can express to the drug product during packaging or the formulation process of the different impurities, which is found in the drug product and they are comparatively few who can influence the performance or stability of the dosage form. These impurities cannot affect the stability or performance of the dosage form, however, should be controlled to produce a secure drug product.
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