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    Quality Control OF Bulk Drug Formulations
    Quality Control OF Bulk Drug Formulations
    Quality Control OF Bulk Drug Formulations
    Ebook42 pages29 minutes

    Quality Control OF Bulk Drug Formulations

    By NELLORE DHARANI SAI SREEKANTH

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    About this ebook

    The book contains essential information on subjects of impurity profiling in pharmaceuticals, drug stability and theorapeutic actions, quality control tests of various formulations and excipients.

    LanguageEnglish
    PublisherNELLORE DHARANI SAI SREEKANTH
    Release dateFeb 19, 2018
    ISBN9781386179924
    Quality Control OF Bulk Drug Formulations

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      Book preview

      Quality Control OF Bulk Drug Formulations - NELLORE DHARANI SAI SREEKANTH

      QUALITY CONTROL OF BULK DRUG FORMULATIONS:

      UNIT-01

      IMPURITY PROFILING OF PHARMACEUTICALS :

      The ICH guideline for impurities in pharmaceuticals was developed with joint efforts of regulators and industry representatives from the European Union (EU), Japan and United States and it has helped to ensure that different regions have consistent requirements for the data that should be submitted to various regulatory agencies. The guidelines not only aid the sponsors of New Drug Applications (NDA) or Abbreviated New Drug Application (ANDA) with the type of information that should be submitted with their applications, but also assist the FDA reviewers and field investigators in their consistent interpretation and implementation of regulations. The various regulatory guidelines regarding impurities are as follows:

      1. ICH guidelines  stability testing of new drug substances and products"

      2. ICH guidelines  Impurities in New Drug Substances

      3. ICH guidelines Impurities in New Drug Products- Q3B 4. ICH guidelines Impurities: Guidelines for residual solvents

      SOURCES OF IMPURITIES :

      The impurities usually encountered in pharmaceuticals are synthesis-related, formulation-related or degradation-related. There are two types of impurities in medicines:

      1) Impurities associated with active pharmaceutical ingredients (APIs).

      2) Impurities that are formed during formulation and or with ageing or that are related to the formulated forms.

      Synthesis-related impurities

      Impurities in a drug substance or a new chemical entity (NCE) originate mainly during the synthetic process from raw materials, solvents, intermediates, and by-products. The raw materials are generally manufactured to much lower purity requirements than a drug substance. Hence, it is easy to understand why they can contain a number of components that can in turn affect the purity of the drug substance. Similarly, solvents used in the synthesis are likely to contain a number of impurities that may range from trace levels to significant amounts that can react with various chemicals used in the synthesis to produce other impurities. Intermediates are also not generally held to the purity level of the drug substance— hence the remarks made for the raw materials apply. It is not reasonably possible to theorize all by-products; as a result, any such products that may be produced in the synthesis would be hard to monitor. The pot reactions, i.e., when the intermediates are not isolated, are convenient, economical, and timesaving; however, they raise havoc in terms of the generation of impurities because a number of reactions can occur simultaneously. Incidentally, this problem of numerous

      reactions occurring simultaneously can be also encountered in single reactions where intermediate

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