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Final active pharmaceutical

The P-cyanodiester 4 was prepared by condensation of isovaleraldehyde with diethyl malonate followed by the addihon of potassium cyanide. The cyanodiester 4 was hydrolyzed and decarboxylated to give the P-cyano acid 5. Reduction with Raney nickel gave racemic pregabalin (6), which was resolved with (S)-mandelic acid. The diastereomeric salt was split with wet TH F under neutral conditions to give pregabalin, which was recrystallized from isopropanol (IPA) to give the final Active Pharmaceutical Ingredient (API). [Pg.162]

Characterization starts once the synthetic route has been selected, although there will be opportunities to modify the route if the changes do not impact the final solid state or impurity profile of the final active pharmaceutical ingredient. The primary objective is to understand, through experimentation, the chemical and physical chemical processes involved in the transformation of raw materials to intermediates and products. The primary outcome is a process definition that includes the order of manufacturing steps, process parameter control methodology, process parameter limits, raw material specification, and diagnostic metrics. [Pg.53]

Nitrated intermediates are often dangerous to prepare, store, and fully purge from final active pharmaceutical ingredient. [Pg.14]

In addition, even when the reaction is robust, such considerations as catalyst load, and consequently cost, intellectual property restrictions and commercial availability of the catalyst can become major concerns even though the reaction may be very high yielding. Furthermore, after all these issues have been addressed, heavy metal contamination of the final active pharmaceutical ingredient (API) is a major roadblock, and its removal can add significantly to the cost of the manufacturing of the API. [Pg.104]

Basedonarecentreview[14],anaverageof8.1 steps (chemicaltransformation) are usually required for the production of a final active pharmaceutical ingredient (API) from starting materials obtained from the fine chemical industry. Under such... [Pg.1279]

Although in many cases an enantiopure drug can be safer than the racemate, the advantages are clear. The final formulation of the drug product could be reduced inhalf, potential side effects could be minimized, and the resulting pharmokinetic and pharmacodynamic studies could clearly determine the efficacy of the active pharmaceutical ingredient (API) [21]. [Pg.255]

The majority of active pharmaceutical agents are administered as tablets, and as a result the characterization of compact species is of great interest to formulators. During the compression step, a variety of particle-particle interactions take place, which ultimately lead to the formation of a stable entity. One may envision that the compaction process results in such consolidation of the input solids that the final density of the tablet approaches the true density of the component materials. [Pg.24]

To get a better idea of the complexity of a real application scenario in these industries it makes sense to, once, exemplarily depict the planning processes in a typical production of active pharmaceutical ingredients (API production). Most pharmaceutical companies are looking at planning scenarios in which several hundred individual resources or facilities have to be accounted for, with demands and orders for some thousand final products. The planning horizon is often set to 2-5 years. Next to single equipment, there are facility pools, with one pool consisting of several individual units. [Pg.63]

Eventually, the final criterion, i.e. authorization and access to relevant data, led to the selection of three cases in different chemical companies using batch processes and located in The Netherlands. For reasons of confidentiality the names of these companies cannot be revealed, therefore they are named company A, B and C. Their real names are known to the author. These companies produce coating resins, active pharmaceutical ingredients and plastic granules respectively. By selecting these three... [Pg.121]

Formulation of the drug product, which includes active pharmaceutical ingredients and excipients, into final form suitable to be administered to patients... [Pg.162]

Catalysis is a valuable and indispensable tool in organic synthesis. Transition metals, most preferably precious metals, are often used. However, potential residual metal contamination from these heterogeneously or homogeneously catalyzed reactions may be detrimental to product quality or, as in the case of active pharmaceutical ingredients (API s), the metal concentration in the final product may be regulated. Degussa s Deloxan Metal Scavengers recover valuable precious metals from reaction mixtures and reduce the metal concentration in process solutions to an acceptable level (<5 ppm). [Pg.493]

Complete Chemistry, Manufacturing, and Control (CMC) information provided, including evidence of purity, stability, toxicology testing, and integrity of active pharmaceutical ingredient (API), placebo, and final product. [Pg.187]

Chiral auxiliaries can serve as a chiral template, and the structural motif can be incorporated into an active pharmaceutical. Although the chemistry of the chiral unit can be exploited, this is not a true application of an auxiliary as the unit becomes part of the final molecule. [Pg.444]


See other pages where Final active pharmaceutical is mentioned: [Pg.168]    [Pg.234]    [Pg.152]    [Pg.1401]    [Pg.43]    [Pg.479]    [Pg.46]    [Pg.479]    [Pg.291]    [Pg.398]    [Pg.168]    [Pg.234]    [Pg.152]    [Pg.1401]    [Pg.43]    [Pg.479]    [Pg.46]    [Pg.479]    [Pg.291]    [Pg.398]    [Pg.138]    [Pg.27]    [Pg.315]    [Pg.246]    [Pg.235]    [Pg.406]    [Pg.590]    [Pg.729]    [Pg.49]    [Pg.179]    [Pg.260]    [Pg.260]    [Pg.261]    [Pg.262]    [Pg.265]    [Pg.370]    [Pg.779]    [Pg.8]    [Pg.112]    [Pg.398]    [Pg.374]    [Pg.84]    [Pg.257]    [Pg.583]    [Pg.65]   


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