New PDF release: Active Pharmaceutical Ingredients - Development, Mfg. and

By S. Nussim(ed)

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3): (1) fosfomycin from commodity chemicals, (2) lobetalol from 5-bromoacetyl salicylamide. In either total synthesis or semisynthesis processing, sometimes a desired synthetic transformation is best done by an enzyme. Such synthesis step, whether using a preparation of the enzyme or the host microorganism, will be considered a chemical synthesis step (a biotransformation or a biocatalytic step) and not a fermentation for biosynthesis. Whichever of these routes is used to obtain a bulk drug constitutes the chemical process.

Environ ment is distinctly cleaner than most other areas 3. Aseptic finishing area for bulk drugs (includes solids processing). No chemical processing other than salt formation. Includes all of the above finishing area provisions, but largely in an aseptic processing environment for the preparation of sterile bulk drugs. Requires sterilization equipment, special ventilation systems and much greater partitioning of the space 4. Hazardous processing for toxics, hydrogen, nitration, sulfonation, etc.

Larger continuous contacting vessels for devices for gas=liquid, vapor=liquid, solid=liquid, and liquid= liquid systems will perform less well because of maldistribution and bypassing of the phases worsens as the cross-sectional area of the contacting vessel increases. Such scale-up requires that provisions be made with internal parts to alleviate maldistribution. 44 Rosas h. Flow vessels will exhibit different flow patterns and residence time distributions than smaller vessels, which need to be taken into account so as to design the larger vessel accordingly.

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Active Pharmaceutical Ingredients - Development, Mfg. and Regulation by S. Nussim(ed)


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