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    6 views11 pages

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    Sittie Fahieda Aloyodan

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     Application of quantitative analytical chemistry to:

     The analysis and determination of purity and quality


    of official drugs and chemicals.
     The analysis of chemical constituents found in the
    human body.
     The analysis of medicinal agents and their
    metabolites.

    Quality as Applied to Drug Products:


    Sum of all factors which contribute directly or
    indirectly to the safety, effectiveness and reliability of
    the product.
    Establishment, documentation and implementation
    of an effective system for managing quality which
    involves active participation of management and
    appropriate personnel.
    Quality Assurance
    Covers all matters that influence the quality of a
    product.
    Ensures that pharmaceutical products are of the
    quality required for their intended use.
    Incorporates GMP and other factors i.e. product
    design and development.
    cGMP
    Part of QA; ensures products are consistently
    produced and controlled according to specs or
    quality standards appropriate for intended use
     Part of cGMP; concerned with sampling, specs, testing,
    documentation and release procedures associated with the
    laboratories; follows international and local guidelines
     Guarantees within reasonable limits that a drug product is:
     Free of impurities
     Stable
     Contains the amount of active ingredient/s as stated on
    the label
     Provides optimal release of active ingredient/s when the
    product is administered
    Pharmaceutical Assaying
     Determination of strength, potency & percentage purity
    of pharmaceutical products
    Sets the standards for quality
    Publishes the USP/NF
    Legally recognize compendiums of standards for
    drugs, which include assays and tests for
    determination of strength, quality and purity.
    Monograph
    Specifies the tests to be conducted for a particular
    material or product, the procedures and the
    references for its details and the expected results.
    Certificate of Analysis
    Contains all the tests conducted on a particular
    material or product to show compliance or non-
    compliance with established standards or
    specifications
    Assures that policies inept to economic issues
    associated with manufacturing and distribution
    of products

    With regulatory agencies, serve as final


    authority in product acceptance or rejection

    Identify and prepare SOP’s relative to QC

    Audit and quality monitoring


    Testing of RM’s and representative samples’
    compliance

    In-process tests

    Monitoring of environmental conditions

    Control packaging components

    Main Areas:
    RMQC, IPQC and FPQC
    Capacity of the product to remain:

    Physically Stable

    Chemically Stable

    Microbiologically Stable

    Therapeutically Stable

    Toxicologically Stable

    within specifications
    Established to assure identity, strength, quality
    and purity
    Products must have the same properties and
    characteristics from the time of manufacture
    until its use.
    Minimum acceptable potency level: 90%

    Errors in estimating expiration date:


    a.) alpha error: too early
    b.) beta error: too late
    1.) Volumetric Analysis
    Determination of the volume of a standard solution required to
    react with a given amount of the substance to be analyzed.
    2.) Physicochemical Methods
    Analysis based on physical or chemical properties of the
    substance to be analyzed.
    3.) Gravimetric Analysis
    Separation of the constituent in its natural state or in the form of
    a compound with definite composition to be determined, by
    extraction, precipitation or other means, and then weighing of
    the resulting product.
    4.) Special Methods
    Analysis which require a distinct type of technique.
     Exactly measure a substance’s purity when
    combined with qualitative tests

     Hence, a complete analysis requires not only


    quantitative determinations but also qualitative
    tests to determine strength, potency and purity
    of a drug or pharmaceutical product.

     Mastery of theoretical considerations is required


    and should be applied throughout each step of
    analytical procedures.

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