There has been ever increasing interest in impurities present in Active Pharmaceutical Ingredient’s
(API’s). Nowadays, not only purity profile but also impurity profile has become mandatory according
to the various regulatory authorities. In the pharmaceutical world, an impurity is considered as
an inorganic or organic material, or residual solvents other than the drug substances, or ingredients,
arising out of synthesis or unwanted chemicals that remains with APIs. Impurity profiling includes identification,
structure elucidation and quantitative determination of impurities and degradation products in
bulk drug materials and pharmaceutical formulation. The control of impurities in Formulated products
and API’s were regulated by various regulatory authorities like ICH, USFDA, Canadian Drug, and
Health Agency. Impurity profiling is very important in the modern pharmaceutical analysis due to the
fact that unidentified, potentially toxic impurities are hazardous to health and in order to increase the
safety of drug therapy, impurities should be identified and determined by the selective method. Nowadays,
it is a mandatory requirement in various pharmacopeias to know the impurities present in APIs
and finished drug products. Thus, impurity profiling can act as a Quality Control tool. It can provide
crucial data regarding the toxicity, safety, various limits of detection and limits of quantitation of several
organic and inorganic impurities, usually accompany with APIs and finished products. There is a
strong requirement to have unique specifications/standards with regard to impurities.
FDA draft guidance on compounding animal drugs from bulk drug substances: a commentary