Several impurities in the drug product can be produced since the excipients utilize in a drug substance formulation. In addition, there are different conditions in the formulation process of passing through a drug substance, which can cause its degradation or other unwanted reactions. Due to hydrolysis or solvolysis, the suspensions and solutions are prone to degradation.
The same reactions can also occur in the solid dosage form in case of capsules and tablets, as solvent or water is used in the process of granulation. The water utilized in the formulation can not only contribute to its impurities, although can also give an ideal condition for the metal catalyst and hydrolysis. Comparative reactions can be visualized in other solvents which can be used, if there is no caution, then oxidation is fairly possible for oxidizing materials. Similarly, light-sensitive material can maintain photochemical reactions. The mainly reactive impurities are small molecules. In addition to chemical stability, the drug products impurity can cause troubles of performance in the form of toxicity or dosage. It is regularly important to quantitatively determine the level of significant impurities from the drug products and to find the origin of those impurities in their source by using the analytical method.
The same reactions can also occur in the solid dosage form in case of capsules and tablets, as solvent or water is used in the process of granulation. The water utilized in the formulation can not only contribute to its impurities, although can also give an ideal condition for the metal catalyst and hydrolysis. Comparative reactions can be visualized in other solvents which can be used, if there is no caution, then oxidation is fairly possible for oxidizing materials. Similarly, light-sensitive material can maintain photochemical reactions. The mainly reactive impurities are small molecules. In addition to chemical stability, the drug products impurity can cause troubles of performance in the form of toxicity or dosage. It is regularly important to quantitatively determine the level of significant impurities from the drug products and to find the origin of those impurities in their source by using the analytical method.
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