A general scheme is set for the estimation of the
impurities in bulk drug substances by the rational use of chromatographic,
spectroscopic and analytical techniques. The various parameters to be fulfilled
in an impurity profiling of drug substances are discussed. Impurity is definedas any substance coexisting with the original drug, such as starting materialor intermediates or these formed, due to any side reactions. The presence of
these unwanted chemicals, even in small amounts, may influence the efficacy and
safety of the pharmaceutical products. Impurity profiling (i.e., the identity
as well as the quantity of impurity in the pharmaceuticals), is now gaining
critical attention from regulatory authorities.
The different Pharmacopoeias,
such as the British Pharmacopoeia (BP), United States Pharmacopeia (USP), and
Indian Pharmacopoeia (IP) are slowly incorporating limits for allowable levels
of impurities present in the APIs or formulations. The process-relatedimpurities in an active pharmaceutical ingredient (API) can have a significantimpact on the quality and safety of the drug products. The impurity levels in
any drug substance are described as per its biological or toxicological data. It
is quite important for “regulatory” aspect of drug approval to provide
limitation of “related impurities.” Therefore, it is necessary to study the
impurity profile of any API and control it during the manufacturing of a drug
product.
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