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

    July 19-20, 2019

    8th International Conference on Clinical Trials

    | Atlanta, USA
    July 29-30, 2019

    7th European Biopharma Congress

    Stockholm, Sweden
    August 02-03, 2019

    9th International Conference on Pharmaceutical GMP, GCP & Regulatory Affairs

    | Pharmaceutical Research, Education, Expo & Networking | Chicago, USA
    August 19-20, 2019

    24th World Congress on Pharmacology

    Vienna, Austria
    September 11-12, 2019

    14th World Congress on Pharmacology and Toxicology

    Singapore
    September 11-12, 2019

    World Congress on Drug Discovery and Drug Design

    Singapore
    September 18-19, 2019

    6th World Congress on Natural Products, Medicinal Plants and Traditional Medicines

    | Radisson Narita | Tokyo, Japan
    September 25-26, 2019 Hong Kong

    17th World Congress on Drug Formulation & Drug Delivery

    Courtyard by Marriott Hong kong
    September 25-26, 2019

    Asia Pacific Pharmaceutics & Drug Delivery Congress

    Singapore
    October 07-08 2019

    Global Congress on Pharmacology and Therapeutics

    Paris, France
    October 07-08, 2019

    Innovation in Drug Design Techniques and pharmacology

    | Paris, France
    October 10-11, 2019

    15th World Congress on Medicinal Chemistry & CADD

    Dubrovnik | Croatia
    October 14-15, 2019

    19th World Congress on Advances in Pharmaceutical Sciences

    Courtyard Marriott Seoul Times Square | Seoul, South Korea
    Oct 23-24 2019

    11th Annual Biomarkers and Clinical Research Congress

    | Amsterdam, Netherlands
    October 25-26, 2019

    14th International Conference on Biopharma and Biotherapeutics

    | Copenhagen, Denmark
    October 23-24, 2019 | Copenhagen, Denmark

    12th Pharma Congress

    November 04-05, 2019

    Advanced Pharmaceutics and Clinical Research

    | Paris, France
    September 11-12, 2019

    2nd Annual Pharmaceutical Biotechnology Congress

    Singapore
    November 11-12, 2019

    20th Annual Pharma Middle East Congress

    Istanbul, Turkey
    November 14-15, 2019

    2nd World Congress on Bioorganic and Medicinal Chemistry

    Cape Town, South Africa
    November 18-19, 2019

    European Congress on Nanomedicine and Pharmaceutical Nanotechnology

    Prague, Czech Republic
    November 18-19, 2019

    European Conference on Pharmacovigilance & Drug Safety

    Prague | Czech Republic
    November 18-19, 2019

    27th Global Experts Meeting on Neuropharmacology

    Rome, Italy
    November 19-20, 2019

    20th Annual Meet on Pharmaceutical Sciences

    Bangkok, Thailand
    December 02-03, 2019

    15th Annual Congress on Pharmacology and Toxicology

    Paris, France
    April 01-02, 2020

    13th European Biosimilars Congress 2020

    London, Uk
    March 23-24, 2020

    23rd Asia Pacific Pharma Congress

    Singapore
    May 06-07, 2020

    15th Annual Meet on Euro Ethnopharmacology

    Prague | Czech Republic
    May 18-19, 2020

    22nd Annual European Pharma Congress

    Berlin, Germany

    Pharmaceutical Drug Impurities Conference Speakers

    Recommended Sessions

    Related Journals

    Are you interested in