Scribd Logo
Upload

Welcome to Scribd!

  • 10 views

    Chapter 1.2 Manufacturing Process

    Uploaded by

    Arul Prasaad

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd

    Chapter 1.2 Manufacturing Process

    Uploaded by

    Arul Prasaad
    10 views2 pages

    Copyright

    © © All Rights Reserved

    Available Formats

    DOCX, PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    10 views2 pages

    Chapter 1.2 Manufacturing Process

    Uploaded by

    Arul Prasaad

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 2

    1.

    2 MANUFACTURING PROCESS:

    Fig. No. 1.3 Basic API process layout

    1.2.1 STEP BY STEP OPERATIONS IN API:

    RAW MATERIAL

    API SYNTHESIS

    CHEMICAL /
    BIOLOGICAL PROCESS

    PRELIMINARY
    PURIFICATION

    CENTRIFUGATION

    FILTRATION

    CRYSTALLISATION

    DRYING

    TAP MILL

    MICRONISATION

    BLENDING

    PACKING

    DISPATCH

    Fig. No. 1.4 Step by step process

    4
    Active Pharmaceutical Ingredient (API) is defined by U.S. Food & Drug
    Administration as: any substance or mixture of substances intended to be used as
    the active ingredient in the manufacture of a drug (medicinal) product. Such
    substances are intended to furnish pharmacological activity or other direct effect
    in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect
    the structure or function of the body. API may exist in the form of liquids,
    powders, crystals and extracts that obtained by chemical synthesis, plant
    extraction, or biotechnology and is not taken by patients directly. Only when API
    is processed into a pharmaceutical preparation, can the product be used for
    clinical use. The synthesis of APIs is usually a complicated and multi-step
    process involving numerous chemical transformations and operations on a range
    of raw materials with different physical and chemical properties. Specialized
    expertise is needed to achieve the synthesis of these molecules. 

    You might also like