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1 AMBERLITE IRC747 Industrial Grade Chelating Resin PRODUCT DATA SHEET Lenntech Tel Fax AMBERLITE IRC747 is a resin of macroporous structure. Its polystyrenic matrix, crosslinked with DVB, contains aminophosphonic groups. The chemical nature of these groups is such that they form complexes with metal ions. The operating capacity for Calcium can be 20 % more than, and the capacity for Strontium and Barium as much as double, that for Duolite C467. This brings improved cycle times, especially for brine with higher Sr content. PROPERTIES Matrix Styrene divinylbenzene copolymer Functional groups -CH 2 -NH-CH 2 -PO 3 Na 2 Physical form Beige beads Ionic form as shipped Na + Total exchange capacity [1] 1.75 eq/l (Na + form) Moisture holding capacity [1] 64 to 69 % (Na + form) Specific gravity 1.10 to 1.14 (Na + form) Shipping weight 755 g/l (47.1 lb/ft 3 ) Harmonic mean size mm Uniformity coefficient 1.8 Fine contents [1] < mm : 2.0% max Coarse beads > mm : 5.0% max Maximum reversible swelling H + Na + : 45 % [1] Contractual value Test methods are available on request SUGGESTED OPERATING CONDITIONS Maximum operating temperature 80 C (175 F) Minimum bed depth 700 mm (28 inches) Service flow rate up to 40 BV/h (5 gpm/ft 3 ) Regeneration HCl (1N to 2N) Conversion to Na + form NaOH (1N to 2N) Operating ph Function of applications * 1 BV (Bed Volume) = 1 m 3 solution per m 3 resin PERFORMANCE Characteristic Reaction R-CH 2 -NH-CH 2 -PO 3 Na 2 + M 2+ R-CH 2 -NH-CH 2 -PO 3 M + 2 Na+ RELATIVE AFFINITY The relative affinity of this resin for the various cations decreases in the order shown below : Pb 2+ > Cu 2+ > Zn 2+ > Mg 2+ > Ca 2+ > Cd 2+ > Ni 2+ > Co 2+ > Sr 2+ > Ba Rohm and Haas Company IE-643 EDS - Jan. 02-1/2

2 OPERATING ph RANGE The resin can operate in a neutral, acidic or alkaline medium, but since its capacity depends on the ph, we recommend the following minimum ph values. ph minimum Cations Cu 2+ Zn 2+ Cd 2+ Mg 2+ Pb 2+ Ca 2+ Ni 2+ Co 2+ APPLICATIONS Brine Purification AMBERLITE IRC747 is a very efficient resin for the removal of Ca, Mg, and other metals present in trace quantities (a few ppm) in concentrated brine, e.g. chlor-alkali electrolysis. Zinc separation Separation of zinc from media in which this metal is present (corrosion preventive products in cooling towers). Lead separation Separation of lead from industrial effluents (oil refinery and battery factory wastes, solvents and wastes from the manufacture of paints and printing inks) HYDRAULIC CHARACTERISTICS Figure 1 shows the bed expansion of AMBERLITE IRC747 as a function of backwash flow rate and temperature. Expansion (%) Figure 1 : % Bed Expansion in Water 10 C Linear velocity (m/h) 20 C 40 C Figure 2 provides the pressure drop profile for AMBERLITE IRC747 in brine. Pressure drop (kg/cm 2 /m) 1 0,8 0,6 0,4 0,2 0 Figure 2 : Pressure Drop in Brine Linear velocity (m/h) LIMITS OF USE 20 C 60 C AMBERLITE IRC747 is suitable for industrial uses. For specific applications such as pharmaceutical, food processing or potable water applications, it is recommended that all potential users seek advice from Rohm and Haas in order to determine the best resin choice and optimum operating conditions. All our products are produced in ISO 9002 certified manufacturing facilities. AMBERJET is a trademark of Rohm and Haas Company and its affiliates, Philadelphia, U.S.A. Ion exchange resins and polymeric adsorbents, as produced, contain by-products resulting from the manufacturing process. The user must determine the extent to which organic by-products must be removed for any particular use and establish techniques to assure that the appropriate level of purity is achieved for that use. The user must ensure compliance with all prudent safety standards and regulatory requirements governing the application. Except where specifically otherwise stated, Rohm and Haas Company does not recommend its ion exchange resins or polymeric adsorbents, as supplied, as being suitable or appropriately pure for any particular use. Consult your Rohm and Haas technical representative for further information. Acidic and basic regenerant solutions are corrosive and should be handled in a manner that will prevent eye and skin contact. Nitric acid and other strong oxidising agents can cause explosive type reactions when mixed with Ion Exchange resins. Proper design of process equipment to prevent rapid buildup of pressure is necessary if use of an oxidising agent such as nitric acid is contemplated. Before using strong oxidising agents in contact with Ion Exchange Resins, consult sources knowledgeable in the handling of these materials. Rohm and Haas Company makes no warranties either expressed or implied as to the accuracy or appropriateness of these data and expressly excludes any liability upon Rohm and Haas arising out of its use. We recommend that the prospective users determine for themselves the suitability of Rohm and Haas materials and suggestions for any use prior to their adoption. Suggestions for uses of our products of the inclusion of descriptive material from patents and the citation of specific patents in this publication should not be understood as recommending the use of our products in violation of any patent or as permission or license to use any patents of the Rohm and Haas Company and its affiliates. Material Safety Data Sheets outlining the hazards and handling methods for our products are available on request Rohm and Haas Company IE-643 EDS - Jan. 02-2/2

3 AMBERLITE IRP64 Pharmaceutical Grade Cation Exchange Resin (Polacrilex Resin) Lenntech Tel Fax Description AMBERLITE IRP64 [1] resin is an insoluble, weakly acidic, hydrogen form, cation exchange resin supplied as a dry, fine powder. AMBERLITE IRP64 resin is suitable for use in pharmaceutical applications, primarily as a carrier for certain basic (cationic) drugs and related substances. It is also used to mask objectionable tastes associated with certain basic drugs. Commercial examples of its use include: Stabilization of Vitamin B12 Sustained Release of Nicotine A Drug Master File for this product is maintained with the United States Food and Drug Administration. Letters of authorization granting access to the file by FDA in support of NDA and ANDA submittals will be provided upon request. Similar assistance can also be offered in support of the registration of formulations containing AMBERLITE IRP64 in many other countries. AMBERLITE IRP64 resin is manufactured in accordance with Good Manufacturing Practices (cgmp) for bulk pharmaceutical chemicals. Identification AMBERLITE IRP64 resin can be identified by infrared spectroscopy, as shown in the sample spectrum in Fig. 1. Table 1: Typical Properties These properties are typical but do not constitute specifications. Ionic form Appearance IR Identification Exchange capacity «as is Hydrogen White to off white fine powder free of foreign matter and any agglomeration Conforms to reference spectrum assay Not less than 10.0 meq/g, on dried basis

4 Purify testing Sodium Not more than 0.20 % Heavy metals Not more than % Iron Not more than 0.01 % Methacrylic acid Not more than 300 ppm Water extractable impurities Not more than 2.0 % Physico-chemical testing Loss on drying Not more than 5.0 % Particle size > mm Not more than 1.0 % > mm to 30.0 % > mm Not more than 70.0 % Microbial purity Total bacterial count Total mold count Not more than 100 cfu/g Not more than 100 cfu/g [1] The use of AMBERLITE pharmaceutical grade ion exchange resins as components of drug formulations is subject to the Food, Drug, and Cosmetic Act as amended. Chemical Structure AMBERLITE IRP64 resin is derived from a porous copolymer of methacrylic acid and divinylbenzene. The chemical structure of AMBERLITE IRP64 is shown in Figure 2. Applications Applications for AMBERLITE IRP64 resin include: Taste Masking Drug Stabilization Carrier for Cationic Drugs Controlled Release Formulations

5 AMBERLITE IRP64 resin provides a means for binding medicinal agents onto an insoluble polymeric matrix. This affords an effective technique for overcoming problems of taste and odor in oral dosage formulations as well as providing a matrix upon which a sustained or controlled release formulation can be developed. The high affinity of AMBERLITE IRP64 resin for the hydrogen ion results in ready desorption of adsorbed species by exposure to an acidic environment, such as that exhibited in the stomach. This accounts for the higher desorption efficiencies versus a strong acid cation resin like AMBERLITE IRP69. Chemical instability problems can sometimes be resolved by adsorption on to AMBERLITE IRP64 resin. For example, complexes of AMBERLITE IRP64 resin with cyanocobalamin (Vitamin B12), a nonionic material, have been used for many years as a means of providing a stable oral dosage form of this vitamin. Drug Loading Batch equilibration is the preferred practice when loading a drug or other sorbate into finely divided ion exchange operations normally used with ion exchange resins, resin powders. Due to its fine particle size, AMBERLITE IRP64 resin does not lend itself to conventional columnar operations normally used with ion exchange resins. The mobile, or exchangeable, cation in IRP64 resin is the hydrogen ion. In acidic environments (generally below ph 4) AMBERLITE IRP64 resin exists as the free acid in an essentially nonionic state. Adsorption (loading) onto this cation exchange resin is usually carried out at ph 6 or higher. The amount of drug loaded onto AMBERLITE IRP64 resin will be influenced by such factors as: The inherent affinity or selectivity between the ion exchange resin and the drug. The concentration of the drug in the loading solution. The concentration and selectivity of competing cations. The ph of the loading solution. The rate of loading will be affected by the activity of the drug and its molecular dimensions as well as the extent to which the polymer phase is swollen during loading. When utilizing a batch or equilibrium contact to load a drug or other anionic sorbate onto AMBERLITE IRP64 resin, it may be desirable to load as much as possible of the substance of value onto the resin. Complete transfer of the drug from the loading solution is not likely in a single equilibrium stage. Accordingly, more than one equilibration may be required in order to achieve the desired loading onto the resin. The use of two or more loading stages, separating the resin from the liquid phase between stages, is an effective means of achieving maximum loading of the drug onto the resin while maintaining minimum loss of drug from the liquid phase of the final stage. Carefully controlled laboratory experiments are required to establish precise loading and elution conditions. Drug Release The rate and completeness of drug desorption in vivo will be controlled by the diffusion rate of the drug through the polymer phase of the resin, (usually a function of molecular weight), the selectivity of the drug for the resin, and the concentration of electrolytes particularly in the hydrogen ion, in the desorption environment. More hydrophobic drugs will usually elute from the resin at a lower rate, as will drugs with a relatively high selectivity for the carboxylic acid functional structure in the resin. Other resin-sorbate interactions are possible, and these can have a pronounced effect upon loading capacities and rates. An example of this might be the presence of a transition metal in the structure of the sorbate molecule which can result in considerable selectivity through the formation of a coordination compound with the resin.

6 Safe Handling Information Material Safety Data Sheets (MSDS) are available for all Rohm and Haas products. These sheets contain pertinent information that you may need to protect your employees and customers against any known health or safety hazards associated with our products. We recommend that you obtain copies of our MSDS by calling RH- AMBER before using our products in your facilities. We also suggest that you contact your suppliers of other materials recommended for use with our products for appropriate health and safety precautions before using them. Caution: Acidic and basic regenerant solutions are corrosive and should be handled in a manner that will prevent eye and skin contact. In addition, the hazards of other organic solvents should be recognized and steps taken to control exposure. Nitric acid and other strong oxidizing agents can cause explosive reactions when mixed with ion exchange resins. Proper design of process equipment to prevent rapid buildup of pressure is necessary if use of an oxidizing agent such as nitric acid is contemplated. Before using strong oxidizing agents in contact with ion exchange resins, consult sources knowledgeable in the handling of these materials. Note: Ion exchange resins and polymeric adsorbents, as produced, contain by-products resulting from the manufacturing process. The user must determine the extent to which organic by-products must be removed for any particular use and establish techniques to assure that the appropriate level of purity is achieved for that use. The user must ensure compliance with all prudent safety standards and regulatory requirements governing the application. Except where specifically otherwise stated, Rohm and Haas Company does not recommend its ion exchange resins or polymeric adsorbents as supplied as being suitable or appropriately pure for any particular use. Consult your Rohm and Haas technical representative for further information. AMBERJET is a trademark of Rohm and Haas Company and its affiliates, Philadelphia, U.S.A. Ion exchange resins and polymeric adsorbents, as produced, contain by-products resulting from the manufacturing process. The user must determine the extent to which organic by-products must be removed for any particular use and establish techniques to assure that the appropriate level of purity is achieved for that use. The user must ensure compliance with all prudent safety standards and regulatory requirements governing the application. Except where specifically otherwise stated, Rohm and Haas Company does not recommend its ion exchange resins or polymeric adsorbents, as supplied, as being suitable or appropriately pure for any particular use. Consult your Rohm and Haas technical representative for further information. Acidic and basic regenerant solutions are corrosive and should be handled in a manner that will prevent eye and skin contact. Nitric acid and other strong oxidising agents can cause explosive type reactions when mixed with Ion Exchange resins. Proper design of process equipment to prevent rapid buildup of pressure is necessary if use of an oxidising agent such as nitric acid is contemplated. Before using strong oxidising agents in contact with Ion Exchange Resins, consult sources knowledgeable in the handling of these materials. Rohm and Haas Company makes no warranties either expressed or implied as to the accuracy or appropriateness of these data and expressly excludes any liability upon Rohm and Haas arising out of its use. We recommend that the prospective users determine for themselves the suitability of Rohm and Haas materials and suggestions for any use prior to their adoption. Suggestions for uses of our products of the inclusion of descriptive material from patents and the citation of specific patents in this publication should not be understood as recommending the use of our products in violation of any patent or as permission or license to use any patents of the Rohm and Haas Company and its affiliates. Material Safety Data Sheets outlining the hazards and handling methods for our products are available on request.