Application Guide
Ion Exchange Resins for
Pharmaceutical Production
D em ineralisation of W ater
Many pharmaceutical processes require softened, or demineralized, water in theirmanufacturing process. Purolite produces the whole range of cation and anionexchange resins required to soften, or totally demineralize, water. These resins areproduced to meet FDA and EU regulatory requirements, which specify permittedchemicals used in their manufacture, maximum release of TOC and other chemicalsto the product water, together with analytical methods for their detection and theconditions of use of the resin products.
manufacture is often treated by UV radiation, immediately following ion exchange orat the point of use.
D rug Purification
Ion exchange resins and adsorbents can be used in many different drug-processingapplications, stabilisation . Purification alone, for example, may consist of different stages andprocesses: chromatographic separation; decolo rization; deashing; metals removal; andconversion. The process may also take advantage of heterogene ous catalyticreactions The use ion exchange resins and selective adsorbents results in the advantage ofhigher purity of the final product, together with minimization of losses, due the highcapacity and selectivity of the resins.
The most suitable ion exchange resins and adsorbents for a given application areselected on consideration of functional groups (weak or strong, acid or base, neutral),porosity, pore diamete r, hydrophilic / hydrophobic nature, and ability to resist fouling.
Often, the final resin selection is a compromise between the capacity, selectivity andelution profile. Industrial antibiotics production from fermentation broths is a significantarea of both ion exchange and synthetic adsorbent use.
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Telephone: (1) 610-668-9090
Telephone: +44 1443 229334 Telephone: +86 571 876 31385 Fax: (1) 610-668-8139 Fax: +44 1443 227073 www.purolite.com
C ephalosporin-C
The manufacture of Cephalosporin -C typically takes place in a number of sequentialsteps.
A fermentation broth is produced containing 5 to 15 g/l cephalosporin, together withimpurities, which is then passed through a weak base anion exchanger to removeresidual ion s and to decolorize . Decolonization is completed using an adsorbent resin,prior Cephalosporin -C is eluted from the adsorbent resin using isopropyl alcohol, andconverted to the sodium form using a strong acid cation resin. Purolite manufactures allresins and adsorbents for these processes Streptom ycin Sulphate Production
The manufacture of Streptomycin is typically carried out in the following sequential steps.
A fermentation broth is produced containing Streptomycin in the presence ofimpurities. The fermentation broth is filtered, and the clear extract passed through a weakacid cation bed to extract the Streptomycin. The Streptomycin is eluted using hydrochloricacid, decolo rized and converted to the sulphate form using a strong base anionresin. Freezing and drying achieve purification .
O ther Processes and Applications
The extraction of opium alkaloids, enzymes (such as, lysozyme from albumen),heparin, together with the extraction decolo rization and stabilization of vitamins, are further examples of the applicationof Sodium form strong acid cation exchangers are used to remove calcium ions fromcollected blood to inhibit coagulation without the use of additional chemicals.
Carboxylic resins are used to remove zinc ions from blood plasma.
Strong are also used in the analytical determination sodium levels in blood, and in the analysis of urine.
Purolite offers hydrophobic adsorbent products for adsorption and reverse phase
chromatography to separate proteins, insuline, peptides, nucleonic acids, targeted
antibiotics and many more specific pharmaceutica l compounds and solutions.
USA Europe Asia Pacific
Telephone: (1) 610-668-9090
Telephone: +44 1443 229334 Telephone: +86 571 876 31385 Fax: (1) 610-668-8139 Fax: +44 1443 227073 www.purolite.com

Source: http://www.purolite.com/customized/uploads/pdfs/appguide_productionixph_10_15_08.pdf

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