Pharmaceutical Drug Impurities

The impurities may be closely related to the product that is formed during the synthesis of a bulk drug or maybe a decomposition product formed during the storage of the drug. The International Conference on Harmonization (ICH) has published guidelines on impurities in new substances, products, and residual solvents. According to the ICH guidelines, an impurity must not exceed 0.1% and the total impurity must not exceed 1.0% in the manufacture of each batch of the drug. The impurities present in excess of 0.1% must be identified and quantified by sufficiently selective methods. The process of identification and quantification of impurities is known as impurity profile. The process of profiling impurities begins with the detection of impurities by thin layer chromatography, high-performance liquid chromatography or gas chromatography. The presence of impurities in the bulk drug can be identified using the impurity reference standard, which includes the products of predictable side reactions or degradation products. If the retention time of both (impurities present in the reference standard of crude drug and impurities) matches, then the impurities present will be easily identified. In case of incorrect identification, an analytical method is used, either LC / MS or GC / MS. According to the information on MS, the structure of the impurity will be proposed. The important step in the profiling of impurities is the synthesis of the material (standard of impurities) with the proposed structure. The retention and spectral correspondence of the material synthesized with the impurity present in the bulk drug is useful for the development of the analytical method and the validation of the method. It is essential to know the structure of the impurities present in the bulk drug in order to alter the reaction conditions of the drug and reduce the number of impurities to an acceptable level.

  • Biological Evaluation of Some Known and Unknown Impurities
  • Identification and Physicochemical Characteristics of various Process-Related Impurities
  • Synthesis and Characterization of an Impurities In Bulk Drug
  • Various analytical methodologies to measure impurity levels
  • Various ways to control impurities in pharmaceuticals.
  • Chiral and Polymorphic Impurities
  • Genotoxic and Metabolite Impurities
  • Impurities arising from API–excipient interaction during formulation

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