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

    Related Conference of Pharmaceutical Drug Impurities

    April 04-05, 2024

    17th European Biosimilars Congress

    Madrid, Spain
    April 11-12, 2024

    5th Annual Congress on Antibiotics and Bacterial Infections

    Amsterdam, Netherlands
    May 09-10, 2024

    4th Global Summit on Pharmaceutical Research

    Barcelona, Spain
    May 16-17, 2024

    18th World Drug Delivery Summit

    Rome, Italy
    May 30-31, 2024

    9th Pharmaceutical Chemistry Conference

    Paris, France
    July 25-26, 2024

    34th Annual European Pharma Congress

    Frankfurt, Germany
    September 11-12, 2024

    9th International Conference on Future Pharma and Innovations

    Amsterdam, Netherlands
    September 25-26, 2024

    4th World Congress on Rare Diseases & Orphan Drugs

    Paris, France
    November 26-27, 2024

    3rd World Conference on Pharma Industry and Medical Devices

    Zurich, Switzerland
    November 26-27, 2024

    3rd World Congress on Precision and Personalized Medicine

    Zurich, Switzerland
    November 28-29, 2024

    39th World Congress on Pharmacology and Therapeutics

    Paris, France
    November 28-29, 2024

    12th International Conference on Clinical Trials

    Vancouver, Canada
    December 05-06, 2024

    17th World Drug Delivery Summit

    Dubai, UAE

    Pharmaceutical Drug Impurities Conference Speakers

      Recommended Sessions

      Related Journals

      Are you interested in