Impurities are generally considered to be less than active pharmaceutical ingredients, as they may not have the similar level of pharmacological activity as per the active pharmaceutical ingredients. But, it is not always necessary to be less than active pharmaceutical ingredients. From its use point of view, In the case of purity, the drug substance is compromised, even if there is the additional material with better pharmacological properties. We should evaluate the purity of unrelated material; therefore, some external material there in active pharmaceutical ingredients or drug substance should be considered an impurity, even if it is completely inert or has good pharmacological properties So that its material can be properly evaluated in the drug product. Managing the impurities of the lower level is very important as the drug is taken in huge amounts.
It is significant to separate and characterize degradation products and the number of impurities since it is not all the time possible to characterize unambiguously with generally used hyphenated methods, which is often the first line of defense. These methods use detectors such as the mass spectrometer, diode array UV detector, high-performance liquid chromatography, and capillary electrophoresis, etc. and many others are very useful and can reduce the time required to characterize impurities.
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