Dialysis composition

Abstract

The present invention relates to an acid concentrate dialysis composition comprising a mixture of citric acid and citrate, having pH of less than 3.0, wherein the total concentration of citrate is between 35 mM and 450 mM, and wherein the amount of citric acid is more than 50% of the total concentration of citrate. The acid concentrate dialysis composition is to be combined to form a dialysis solution having a total concentration of citrate of between 1 and 6 mM.

Claims

1. An acid concentrate dialysis composition comprising: 3500-4622 mM sodium chloride; 105-180 mM potassium chloride; greater than 56.3 and up to 96.75 mM calcium chloride; 17.5-22.5 mM magnesium chloride; 35-45 g/L glucose; chloride determined by electroneutrality; and a mixture of citric acid and citrate, wherein the total concentration of citrate is 35 mM to 270 mM, the amount of citric acid is about 75% or more of the total concentration of citrate, and the acid concentrate dialysis composition has a pH of less than 3.0.

2. The acid concentrate dialysis composition according to claim 1, wherein the amount of citric acid is about 80% or more of the total concentration of citrate.

3. The acid concentrate dialysis composition according to claim 1, wherein the dialysis composition has a pH of less than 2.8.

4. The acid concentrate dialysis composition according to claim 1, wherein the citrate is selected from sodium, potassium, calcium, or magnesium salt of citric acid.

5. The acid concentrate dialysis composition according to claim 1, wherein the citrate is selected from sodium dihydrogen citrate, disodium hydrogen citrate, trisodium citrate, trisodiumcitrate dihydrate, potassium dihydrogen citrate, dipotassium hydrogen citrate, calcium citrate, and magnesium citrate.

6. The acid concentrate dialysis composition according to claim 1, wherein the dialysis composition has a pH of less than 2.6.

7. The acid concentrate dialysis composition according to claim 1, wherein the dialysis composition has a pH of less than 2.5.

8. The acid concentrate dialysis composition according to claim 1, wherein the citrate is selected from trisodium citrate, disodium hydrogen citrate, and monosodium dihydrogencitrate.

9. A package comprising the acid concentrate dialysis composition of claim 1.

10. A process for manufacturing the acid concentrate dialysis composition of claim 1, the process comprising: a) dissolving sodium chloride in water; b) dissolving electrolytes by mixing with the mixture of a); c) dissolving citric acid; d) mixing the sodium chloride, electrolytes, and citric acid as of a, b and c to obtain a mixture; and e) adding citrate to the mixture obtained in d) to obtain the acid concentrate dialysis composition, wherein step a), b), c), and d) are performed sequentially, in any order, or two or more steps simultaneously.

11. A method of preparing a dialysis solution, the method comprising: providing the acid concentrate dialysis composition of claim 1; and mixing the acid concentrate dialysis composition with a bicarbonate-containing solution.

Description

DETAILED DESCRIPTION OF THE INVENTION

(1) For patients having a chronic kidney dysfunction there is a need of improved therapies. For dialysis patients who shall avoid heparin, the selection of possible procedures of treatment is limited. A possible alternative may be a combination of treatment with heparin together with citrate. However, it would be an improved patient compliance to be able to completely replace the heparin with citrate. As stated above, when using citrate within dialysis compositions, one specific effect has to be taken into account, namely its ability to form a complex with, in particular, divalent electrolytes like calcium and magnesium and precipitate in the fluid. It is a challenge to provide dialysis solutions comprising citrate in a concentration of more than 1 mM of citrate. Most desirable is a solution having a concentration of at least 3 mM, then it would be possible to replace the heparin with citrate.

(2) In one embodiment the acid concentrate dialysis composition of the present invention comprises a mixture of citric acid and citrate having pH of less than 3.0.

(3) It has surprisingly been found that the acid concentrate dialysis composition comprising citric acid solution shall also comprise citrate in a specific concentration and/or ratio, and be acidic with a pH less than 3.0. There are other options available to obtain desired pH of the acid concentrate dialysis composition, for example by adding a base in an amount to provide a fluid with the specified pH. Examples of suitable bases are sodium hydroxide (NaOH) and bicarbonate, such as sodium bicarbonate.

(4) It has been found that when an acid concentrate including citric acid and citrate, and the solution is kept at pH less than 3.0, the solution is less prone to precipitate and the formation of salt complexes (for example of calcium and magnesium) is reduced. The precipitation may be substantially reduced, or completely avoided.

(5) The acid concentrate dialysis composition comprising citric acid and citrate may comprise the components in amounts where the amount of citric acid in the composition is more than 50% of the total concentration of citrate. For example, the amount of citric acid is equal or more than 60% of the total concentration of citrate; further example more than 70% of the total concentration, or more than 75 of the total concentration, for example 80% of the total concentration. The acid concentrate dialysis composition comprising citric acid and citrate may comprise the components in amounts where the citric acid on the composition is between 70 and 85%, such as between 75 and 85%. The acid concentrate may comprise citric acid in an amount of 70, 75, 80, or 85%.

(6) In one embodiment of the invention is an acid concentrate dialysis composition comprising a mixture of citric acid and citrate; wherein the amount of citric acid in the composition is equal or more than 60% of the total concentration of citrate; having pH of less than 2.8.

(7) Further, an acid concentrate dialysis solution as has been described herein comprises the citric acid and the citrate in a specified ratio. The acid concentrate dialysis composition comprises the citric acid and citrate in a balanced form, wherein the ratio of citric acid to citrate is more than 1:1, thus equal amounts of the two specified components. Another example is where the ratio of citric acid to citrate is more than 2:1.

(8) Another example is where the ratio of citric acid to citrate is between about 1:1 to about 10:1, for example about 1:1 to about 6:1. Examples of suitable ratios are 1:1, 1.5:1, 2:1, 2.5:1, 3:1, 3.5:1, 4:1, 4.5:1, 5:1, 5.5:1, 6:1, 7:1, 8:1, 9:1, and 10:1.

(9) It has been shown advantageously to select a specific ratio of the content of citric acid and the citrate, to avoid precipitation of calcium complex with citrate.

(10) Another embodiment of the invention is an acid concentrate dialysis composition comprising a mixture of citric acid and citrate; wherein the ratio of citric acid to citrate is more than 1:1; having pH of less than 3.0.

(11) Further stability of the acid concentrate dialysis composition may be achieved in compositions comprising a mixture of citrate and citric acid in a specified concentration, with a specific ratio between the citric acid and citrate, together with a determined total concentration of citrate.

(12) In one embodiment of the invention is an acid concentrate dialysis composition comprising a mixture of citric acid and citrate; wherein the amount of citric acid in the composition is more than 50% of the total concentration of citrate; wherein the ratio of citric acid to citrate is more than 1:1; having pH of less than 3.0.

(13) The pH of the acid concentrate dialysis composition shall be less than 3.0, to avoid the forming of calcium complex, and to obtain a more stable concentrate composition. The acid concentrate dialysis composition as described herein shall have a pH of less than 2.8, for example the pH of the concentrate composition is less than 2.6, such as less than 2.5. For example, the acid concentrate dialysis composition has a pH of between 0.5 and 2.8; preferably pH between 1.0 and 2.6; more preferably, pH between 1.5 and 2.5.

(14) For example the pH is more than pH 1.5, and less than pH 2.6; preferably pH is between 1.5 and 2.5; more preferably pH is between 2 and 2.4, for example between 2 and 2.2.

(15) Further, in one embodiment of the invention an acid concentrate dialysis composition is provided wherein the total concentration of citrate is up to 450 mM; the ratio of citric acid to citrate is more than 1:1; and pH is less than 3.0, preferably the total concentration of citrate is up to 270 mM.

(16) Further, in one embodiment of the invention an acid concentrate dialysis composition is provided wherein the total concentration of citrate is up to 450 mM; the ratio of citric acid to citrate is between 1:1 and about 10:1; and pH is between 1.5 and 2.5, preferably the total concentration of citrate is up to 270 mM.

(17) The acid concentrate dialysis composition provided may have a total concentration of citrate of between 35-270 mM; a ratio of citric acid to citrate between 2:1 and about 6:1; and pH is between 1.5 and 2.5.

(18) In the acid concentrate dialysis composition described herein, the total concentration of citric acid and citrate may be selected between 35 mM and 270 mM.

(19) The citrate may be present in form of sodium, potassium, calcium, or magnesium salt of citric acid. Also salts of iron, selenium and zinc are suitable for the acid concentrate dialysis composition illustrated herein. There are different salts available for the acid concentrate dialysis composition as defined herein. These are, for example, selected from sodium dihydrogen citrate, disodium hydrogen citrate, trisodium citrate, trisodiumcitrate dehydrate, potassium dihydrogen citrate, dipotassium hydrogen citrate, calcium citrate, and magnesium citrate. More specifically, the acid concentrate dialysis composition is selected from trisodium citrate, disodium hydrogencitrate, and monosodium dihydrogencitrate.

(20) In one embodiment an acid concentrate dialysis composition comprising trisodium citrate is provided.

(21) Another embodiment of the invention an acid concentrate dialysis composition is provided wherein the citrate is trisodium citrate; total concentration of citrate is less than 270 mM; citric acid is present in an amount of 60% of total concentration of citrate; pH is between 0.5 and 2.8.

(22) Another embodiment of the invention an acid concentrate dialysis composition is provided wherein the citrate is trisodium citrate; total concentration of citrate is between 35 mM and 270 mM; concentration of the citric acid is equal or more than 35 mM; and pH is between 0.5 and 2.8, preferably pH is between 1.0 and 2.6; more preferably pH is between 1.5 and 2.5.

(23) Salts of citric acid to be used in the acid concentrate dialysis composition may be formed by forming sodium, potassium, calcium, or magnesium salt, citrates. As citrate is trivalent there are different forms available for salts of citric acid. All these different forms are intended to be included in the invention presented herein. The different forms of citrates are sodium dihydrogen citrate, disodium hydrogen citrate, trisodium citrate, trisodiumcitrate di hydrate, potassium dihydrogen citrate, dipotassium hydrogen citrate, calcium citrate, and magnesium citrate.

(24) Preferably, citrate to be included in composition described herein is selected from trisodium citrate, disodium hydrogencitrate, and monosodium dihydrogencitrate.

(25) The acid concentrate dialysis compositions may also comprise one or more electrolytes to form a suitable dialysis solution. Components to be included together with the citric acid and the citrate are physiologically acceptable cations such as sodium (Na.sup.+), potassium (K.sup.+), calcium (Ca.sup.2+), magnesium (Mg.sup.2+), and chloride (Cl.sup.).

(26) Dialysis solutions may also contain components like glucose. Therefore the present acid concentrate dialysis composition may contain certain amount of glucose, for example in a concentration of 0-11 mM.

(27) The acid concentrate dialysis composition may also comprise components like physiologically acceptable buffering anions. Examples of such suitable components are acetate and lactate, or salts thereof. These components may be present in the acid concentrate dialysis composition in an amount of 0.01 to 150 mM. The dialysis fluid prepared from the acid concentrate dialysis composition may comprise the physiologically acceptable buffering anions in a concentration of 0.2 to 0.5 mM.

(28) Thus, the acid concentrate compositions may comprise, besides the citrate and citric acid, further components like: sodium, potassium, magnesium, chloride, glucose, calcium, to form an acid concentrate composition intended to be combined and mixed with a base, for example a basic solution comprising bicarbonate to form a final dialysis composition. The solution provided is then suitable for the dialysis treatments described herein.

(29) An example of acid concentrate dialysis composition is an acid concentrate comprising:

(30) The compositions of the invention are acid concentrate dialysis solution intended to be diluted before use in a dialysis treatment. The concentrated compositions shall be diluted more than 30 times before its use (thus 1 part concentrate to be mixed with 29 parts water). For example, the acid concentrate dialysis composition is diluted 35 times (1:35), thus dilution according to 1+34. Another option is to dilute the acid concentrate dialysis composition 45 times (1:45), thus to dilute according to 1+44. A further option is an acid concentrate for dilution 200 times (1:200). This acid concentrate does not contain any sodium chloride. Sodium chloride is provided from a separate source when preparing the ready-to-use dialysis solution. These dilutions shall be considered as examples, not any limitation.

(31) An acid concentrate dialysis composition may have the following general composition:

(32) TABLE-US-00001 General Composition for dilution 1:35 and 1:45, respectively (amounts in mM): in concentrate in concentrate0 in diluted solution (1:35) (1:45) Sodium (Na.sup.+) 95-115 3320-4030 4270-5180 Potassium (K.sup.+) 0-4 0-140 0-180 Calcium (Ca.sup.2+) 0-3 0-105 0-135 Magnesium (Mg.sup.2+) .sup.0-1.5 0-53 0-68 Citrate 1-6 35-210 45-270 Glucose 0-11 0-390 0-500 Chloride present in amount to obtain electroneutrality.

(33) An acid concentrate dialysis composition may have the following compositions shown by Compositions I, II, III, IV, V, and VI. The concentrates presented are suitable for 1.35 and 1:45 dilution, respectively.

(34) TABLE-US-00002 in concentrate in concentrate in diluted solution (1:35) (1:45) Composition I (amounts in mM): Sodium (Na.sup.+) 103 3600 4640 Potassium (K.sup.+) 3.0 105 135 Calcium (Ca.sup.2+) 1.4 49 63 Magnesium (Mg.sup.2+) 0.5 18 23 Citrate 1.0 35 45 Glucose 5.5 190 250 Composition II (amounts in mM): Sodium (Na.sup.+) 103 3600 4640 Potassium (K.sup.+) 3.0 105 135 Calcium (Ca.sup.2+) 1.4 50 65 Magnesium (Mg.sup.2+) 0.5 18 23 Citrate 1.25 44 56 Glucose 5.5 190 250 Composition III (amounts in mM): Sodium (Na.sup.+) 103 3600 4640 Potassium (K.sup.+) 3.0 105 135 Calcium (Ca.sup.2+) 1.5 52 67 Magnesium (Mg.sup.2+) 0.5 18 23 Citrate 1.5 53 68 Glucose 5.5 190 250 Composition IV (amounts in mM): Sodium (Na.sup.+) 103 3600 4640 Potassium (K.sup.+) 3.0 105 135 Calcium (Ca.sup.2+) 1.5 53 68 Magnesium (Mg.sup.2+) 0.5 18 23 Citrate 1.75 61 79 Glucose 5.5 190 250 Composition V (amounts in mM): Sodium (Na.sup.+) 103 3600 4640 Potassium (K.sup.+) 3.0 105 135 Calcium (Ca.sup.2+) 1.6 54 70 Magnesium (Mg.sup.2+) 0.5 18 23 Citrate 2.0 70 90 Glucose 5.5 190 250 Composition VI (amounts in mM): Sodium (Na.sup.+) 103 3600 4640 Potassium (K.sup.+) 3.0 105 135 Calcium (Ca.sup.2+) 1.6 52 72 Magnesium (Mg.sup.2+) 0.5 18 23 Citrate 2.25 79 101 Glucose 5.5 190 250 Chloride present in amount to obtain electroneutrality.

(35) The acid concentrate dialysis solution is intended to be used in hemodialysis, for example in dialysis methods like hemofiltration or hemodiafiltration.

(36) A content of citrate and citric acid below 6 mM in a solution ready-to-use as dialysis solution is considered suitable and intended to be used for providing a complete anticoagulation effect. Preferably, the heparin usually used in hemodialysis treatments is replaced with citrate containing products.

(37) The acid concentrate dialysis composition as herein described is intended to be mixed with a physiologically acceptable diluent.

(38) Another embodiment of the invention is a citrate containing dialysis solution comprising the acid concentrate dialysis composition and a physiologically acceptable diluent.

(39) The physiologically acceptable diluent is, for example, a bicarbonate containing solution.

(40) The acid concentrate dialysis composition is to be diluted into a dialysis solution having a total concentration of citrate, thus total concentration of citrate and citric acid, being between 1 mM and 6 mM, for example, the total concentration is between 1 and 5 mM; preferably between 1.5 and 4 mM, for example between 1.5 and 3 mM. For example, the dialysis solution may comprise 1.5, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, or 6 mM.

(41) Another embodiment of the invention is a citrate containing dialysis solution comprising 1 to 6 mM citrate.

(42) The acid concentrate dialysis composition provided wherein the acid concentrate dialysis composition is to be diluted and mixed with a bicarbonate-containing solution into a dialysis solution having a total concentration of citrate between 1 and 6 mM; preferably between 1 and 5 mM; more preferably between 1.5 and 4 mM, and has a physiologically acceptable pH of between 6.5-8, more preferably pH of 6.8-7.5, for example pH of 7.0-7.4.

(43) The acid concentrate dialysis composition is intended to be mixed with a base solution into a final dialysis fluid which may contain

(44) up to 6 mM of citrate,

(45) about 130-150 mM sodium, preferably 135-145 mM sodium, or more preferably 140 mM sodium; and 20-40 mM bicarbonate, preferably 25-35 mM bicarbonate, or more preferably 34 mM bicarbonate;

(46) 0-4 mM potassium;

(47) 0-1.5 mM magnesium;

(48) 0-3 mM calcium;

(49) 0-2 g/L glucose; and

(50) chloride determined by electroneutrality, and has a physiologically acceptable pH of between 6.5-8, more preferably pH of 6.8-7.5, for example pH of 7.0-7.4.

(51) The dialysis fluid may comprise potassium ions in a concentration of 0-4 mM. For example the dialysis fluid comprises 0, 1, 2, 3, or 4 mM of potassium. The potassium ions may be added as potassium chloride, or any other physiologically acceptable form.

(52) The dialysis fluid may comprise magnesium ions in a concentration of 0-1.5, for example in a concentration of 0, 0.5, 0.75, 1.0, 1.25, or of 1.5 mM. The magnesium ions may be added as magnesium chloride, or any other physiologically acceptable form.

(53) The dialysis fluid may comprise calcium ions in a concentration of 0-3 mM, for example in a concentration of 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, and 3 mM. The calcium ions may be added as calcium chloride, or any other physiologically acceptable form.

(54) When increasing the amount of total citrate within the dialysis fluid, the amount of bicarbonate has to be adjusted towards the lower end of the ranges given above. This applies especially when citrate is added to the composition.

(55) A citrate containing dialysis solution comprising the acid concentrate dialysis composition as herein described is one of the embodiments of the invention. This dialysis solution may have a total concentration of citrate of between 1 to 6 mM.

(56) In an embodiment illustrated is an acid concentrate dialysis composition comprising citric acid and citrate wherein total concentration of citrate is between 35 mM and 270 mM; concentration of citric acid is more than 50% or the total concentration of citrate; the ratio of citric acid to total concentration of citrate is more than 1:1; and pH is less than 3.0.

(57) In another embodiment illustrated is an acid concentrate dialysis composition comprising citric acid and citrate wherein total concentration of citrate is between 35 mM and 270 mM; concentration of citric acid is equal or more than 60% or the total concentration of citrate; the ratio of citric acid to total concentration of citrate is more than 1:1; and pH is equal or less than 2.8.

(58) The acid concentrate dialysis composition may be manufactured by a process comprising the following steps: a) dissolve the sodium chloride in water b) dissolve the electrolytes (i.e. potassium, calcium, magnesium) by mixing with the mixture of a) c) dissolve the citric acid; d) mix the dissolved ions of a, b and c; e) dissolve the citrate and add the dissolved citrate to the product obtained in d) and wherein step a), b), c), and d) are performed sequentially, in any order, or two or more steps simultaneously.
The acid concentrate dialysis composition may be provided in a package. The package may be for example a bag, or canister. The package may also be in form of a multicompartment bag, or in form of separate bags containing the above defined components. In one embodiment illustrated herein is a multicompartment bag wherein the acid concentrate dialysis composition comprising the citric acid and citrate is held in one compartment; and calcium and magnesium are kept in a separate compartment of the package. More specifically, the first compartment comprises sodium chloride, potassium chloride, glucose, citric acid, and citrate; and the second compartment comprises calcium chloride, and magnesium chloride.

EXAMPLES

(59) By way of example, without any limitation of the scope, the following examples identify a variety of dialysis compositions pursuant to embodiments of the present invention.

(60) Acid concentrates of the dialysis fluid contain further components in addition to the citric acid and citrate. These additional components may be sodium, potassium, magnesium, chloride, glucose. More specifically the components may be present as sodium chloride (NaCl); potassium chloride (KCl); magnesium Chloride (MgCl.sub.2), glucose; calcium chloride, citric acid, and citrate, preferably in form of trisodium citrate.

(61) For magnesium chloride and calcium chloride there are different hydrated forms available, for example MgCl.sub.26H.sub.2O, MgCl.sub.24.5H.sub.2O, and MgCl.sub.2 anhydrous; CaCl.sub.22H.sub.2O, and CaCl.sub.2. Glucose may be present as anhydrous glucose or hydrous glucose.

(62) In the following examples, compositions as above have been prepared. The amounts of each component as were included in the compositions are specified the following Examples.

(63) The compositions described herein were manufactured according to the following scheme: dissolving the sodium chloride in water; adding citric acid, calcium chloride, and magnesium chloride; and adding citrate to the mixture.
The amounts added of citric acid, citrate and calcium have been varied while the sodium chloride, potassium chloride, magnesium chloride, and glucose were kept constant.

(64) Tests of pH of the compositions have then followed. The pH measurements were performed with pH meter Orion, Model 420 A.

Example 1

(65) TABLE-US-00003 Diluted Concentrate Ingredient: solution (1:35) Sodium chloride (NaCl) 100 mM 3500 mM Potassium chloride (KCl) 3.00 mM 105 mM Magnesium Chloride 0.50 mM 17.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 35.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.40 mM 49.0 mM Citric acid (anhydrous) 1.0 mM 35.0 mM Citrate (trisodium citrate) 0 mM 0 mM pH of the dialysis composition 1.6 Total amount citrate 1.0 mM 35.0 mM Content of citric acid (% of total 100 concentration of citrate)

Example 2

(66) TABLE-US-00004 Diluted Concentrate Ingredient: solution (1:35) Sodium chloride (NaCl) 100 mM 3500 mM Potassium chloride (KCl) 3.0 mM 105 mM Magnesium Chloride 0.50 mM 17.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 35.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.44 mM 50.3 mM Citric acid (anhydrous) 1.25 mM 43.8 mM Citrate (trisodium citrate) 0 mM 0 mM pH of the dialysis composition 1.5 Total amount citrate 1.25 mM 43.8 mM Content of citric acid (% of total 100 concentration of citrate)

Example 3

(67) TABLE-US-00005 Diluted Concentrate Ingredient: solution (1:35) Sodium chloride (NaCl) 100 mM 3500 mM Potassium chloride (KCl) 3.0 mM 105 mM Magnesium Chloride 0.50 mM 17.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 35.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.44 mM 50.3 mM Citric acid (anhydrous) 1.00 mM 35.0 mM Citrate (trisodium citrate) 0.25 mM 8.75 mM pH of the dialysis composition 2.3 Total amount citrate 1.25 mM 43.8 mM Content of citric acid (% of total 80 concentration of citrate)

Example 4

(68) TABLE-US-00006 Diluted Concentrate Ingredient: solution (1:35) Sodium chloride (NaCl) 100 mM 3500 mM Potassium chloride (KCl) 3.0 mM 105 mM Magnesium Chloride 0.50 mM 17.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 35.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.48 mM 51.7 mM Citric acid (anhydrous) 1.25 mM 43.8 mM Citrate (trisodium citrate) 0.25 mM 8.75 mM pH of the dialysis composition 2.2 Total amount citrate 1.50 mM 52.5 mM Content of citric acid (% of total 83 concentration of citrate)

Example 5

(69) TABLE-US-00007 Diluted Concentrate Ingredient: solution (1:35) Sodium chloride (NaCl) 100 mM 3500 mM Potassium chloride (KCl) 3.0 mM 105 mM Magnesium Chloride 0.50 mM 17.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 35.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.51 mM 53.0 mM Citric acid (anhydrous) 1.50 mM 52.5 mM Citrate (trisodium citrate) 0.25 mM 8.75 mM pH of the dialysis composition 2.1 Total amount citrate 1.75 mM 61.3 mM Content of citric acid (% of total 86 concentration of citrate)

Example 6

(70) TABLE-US-00008 Diluted Concentrate Ingredient: solution (1:35) Sodium chloride (NaCl) 100 mM 3500 mM Potassium chloride (KCl) 3.0 mM 105 mM Magnesium Chloride 0.50 mM 17.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 35.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.55 mM 54.3 mM Citric acid (anhydrous) 1.50 mM 52.5 mM Citrate (trisodium citrate) 0.50 mM 17.5 mM pH of the dialysis composition 2.5 Total amount citrate 2.00 mM 70.0 mM Content of citric acid (% of total 75 concentration of citrate)

Example 7

(71) TABLE-US-00009 Diluted Concentrate Ingredient: solution (1:35) Sodium chloride (NaCl) 100 mM 3500 mM Potassium chloride (KCl) 3.0 mM 105 mM Magnesium Chloride 0.50 mM 17.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 35.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.55 mM 54.3 mM Citric acid (anhydrous) 1.60 mM 56.0 mM Citrate (trisodium citrate) 0.40 mM 14.0 mM pH of the dialysis composition 2.3 Total amount citrate 2.00 mM 70.0 mM Content of citric acid (% of total 80 concentration of citrate)

Example 8

(72) TABLE-US-00010 Diluted Concentrate Ingredient: solution (1:35) Sodium chloride (NaCl) 100 mM 3500 mM Potassium chloride (KCl) 3.0 mM 105 mM Magnesium Chloride 0.50 mM 17.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 35.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.59 mM 55.6 mM Citric acid (anhydrous) 1.50 mM 52.5 mM Citrate (trisodium citrate) 0.75 mM 26.3 mM pH of the dialysis composition 2.8 Total amount citrate 2.25 mM 78.8 mM Content of citric acid (% of total 67 concentration of citrate) Precipitation occurred after a week

Example 9

(73) TABLE-US-00011 Diluted Concentrate Ingredient: solution (1:35) Sodium chloride (NaCl) 100 mM 3500 mM Potassium chloride (KCl) 3.0 mM 105 mM Magnesium Chloride 0.50 mM 17.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 35.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.59 mM 55.6 mM Citric acid (anhydrous) 1.75 mM 61.3 mM Citrate (trisodium citrate) 0.50 mM 17.0 mM pH of the dialysis composition 2.5 Total amount citrate 2.25 mM 78.8 mM Content of citric acid (% of total 78 concentration of citrate)

Example 10

(74) TABLE-US-00012 Diluted Concentrate Ingredient: solution (1:35) Sodium chloride (NaCl) 100 mM 3500 mM Potassium chloride (KCl) 3.0 mM 105 mM Magnesium Chloride 0.50 mM 17.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 35.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.48 mM 51.7 mM Citric acid (anhydrous) 1.00 mM 35.0 mM Citrate (trisodium citrate) 0.50 mM 17.5 mM pH of the dialysis composition 2.8 Total amount citrate 1.50 mM 52.5 mM Content of citric acid (% of total 67 concentration of citrate)

Example 11

(75) TABLE-US-00013 Diluted Concentrate Ingredient: solution (1:35) Sodium chloride (NaCl) 100 mM 3500 mM Potassium chloride (KCl) 3.0 mM 105 mM Magnesium Chloride 0.50 mM 17.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 35.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.51 mM 53.0 mM Citric acid (anhydrous) 1.25 mM 43.8 mM Citrate (trisodium citrate) 0.50 mM 17.5 mM pH of the dialysis composition 2.6 Total amount citrate 1.75 mM 61.3 mM Content of citric acid (% of total 71 concentration of citrate)

Example 12

(76) TABLE-US-00014 Diluted Concentrate Ingredient: solution (1:35) Sodium chloride (NaCl) 100 mM 3500 mM Potassium chloride (KCl) 3.00 mM 105 mM Magnesium Chloride 0.50 mM 17.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.00 g/l.sup. 35.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.48 mM 51.7 mM Citric acid (anhydrous) 1.25 mM 43.8 mM Citrate (trisodium citrate) 0.25 mM 8.75 mM pH of the dialysis composition 2.2 Total amount citrate 1.50 mM 52.5 mM Content of citric acid (% of total 83 concentration of citrate)

Example 13

(77) TABLE-US-00015 Diluted Concentrate Ingredient: solution (1:45) Sodium chloride (NaCl) 100 mM 4500 mM Potassium chloride (KCl) 3.0 mM 135 mM Magnesium Chloride 0.50 mM 22.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 45.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.44 mM 64.7 mM Citric acid (anhydrous) 1.00 mM 45.0 mM Citrate (trisodium citrate) 0.25 mM 11.3 mM pH of the dialysis composition 2.2 Total amount citrate 1.25 mM 56.3 mM Content of citric acid (% of total 80 concentration of citrate)

Example 14

(78) TABLE-US-00016 Diluted Concentrate Ingredient: solution (1:45) Sodium chloride (NaCl) 100 mM 4500 mM Potassium chloride (KCl) 3.0 mM 135 mM Magnesium Chloride 0.50 mM 22.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 45.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.48 mM 66.4 mM Citric acid (anhydrous) 1.25 mM 56.3 mM Citrate (trisodium citrate) 0.25 mM 11.3 mM pH of the dialysis composition 2.1 Total amount citrate 1.50 mM 67.5 mM Content of citric acid (% of total 83 concentration of citrate)

Example 15

(79) TABLE-US-00017 Diluted Concentrate Ingredient: solution (1:45) Sodium chloride (NaCl) 100 mM 4500 mM Potassium chloride (KCl) 3.0 mM 135 mM Magnesium Chloride 0.50 mM 22.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 45.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.51 mM 68.1 mM Citric acid (anhydrous) 1.5 mM 67.5 mM Citrate (trisodium citrate) 0.25 mM 11.3 mM pH of the dialysis composition 2.0 Total amount citrate 1.75 mM 78.8 mM Content of citric acid (% of total 86 concentration of citrate)

Example 16

(80) TABLE-US-00018 Diluted Concentrate Ingredient: solution (1:45) Sodium chloride (NaCl) 100 mM 4500 mM Potassium chloride (KCl) 3.0 mM 135 mM Magnesium Chloride 0.50 mM 22.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 45.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.55 mM 69.8 mM Citric acid (anhydrous) 1.50 mM 67.5 mM Citrate (trisodium citrate) 0.50 mM 22.5 mM pH of the dialysis composition 2.4 Total amount citrate 2.00 mM 90.0 mM Content of citric acid (% of total 75 concentration of citrate)

Example 17

(81) TABLE-US-00019 Diluted Concentrate Ingredient: solution (1:45) Sodium chloride (NaCl) 100 mM 4500 mM Potassium chloride (KCl) 3.0 mM 135 mM Magnesium Chloride 0.50 mM 22.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 45.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.25 mM 64.7 mM Citric acid (anhydrous) 1.00 mM 45.0 mM Citrate (trisodium citrate) 0.75 mM 33.8 mM pH of the dialysis composition 3.0 Total amount citrate 1.75 mM 78.8 mM Content of citric acid (% of total 57 concentration of citrate) The solution was stored at room temperature. Precipitation observed after 1 day.

Example 18

(82) TABLE-US-00020 Diluted Concentrate Ingredient: solution (1:45) Sodium chloride (NaCl) 100 mM 4500 mM Potassium chloride (KCl) 3.0 mM 135 mM Magnesium Chloride 0.50 mM 22.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 45.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.25 mM 56.3 mM Citric acid (anhydrous) 1.25 mM 56.3 mM Citrate (trisodium citrate) 0.75 mM 33.8 mM pH of the dialysis composition 2.8 Total amount citrate 2.00 mM 90.0 mM Content of citric acid (% of total 63 concentration of citrate) The solution was stored at room temperature. Precipitation observed after 4 days.

Example 19

(83) TABLE-US-00021 Diluted Concentrate Ingredient: solution (1:45) Sodium chloride (NaCl) 100 mM 4500 mM Potassium chloride (KCl) 3.0 mM 135 mM Magnesium Chloride 0.50 mM 22.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 45.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.25 mM 56.3 mM Citric acid (anhydrous) 1.00 mM 45.0 mM Citrate (trisodium citrate) 0.50 mM 22.5 mM pH of the dialysis composition 2.7 Total amount citrate 1.50 mM 67.5 mM Content of citric acid (% of total 67 concentration of citrate) The solution was stored at 40 degrees Celsius. Precipitation observed after 4 days.

Example 20

(84) TABLE-US-00022 Diluted Concentrate Ingredient: solution (1:45) Sodium chloride (NaCl) 100 mM 4500 mM Potassium chloride (KCl) 3.0 mM 135 mM Magnesium Chloride 0.50 mM 22.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 45.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.25 mM 56.3 mM Citric acid (anhydrous) 1.00 mM 45.0 mM Citrate (trisodium citrate) 0.75 mM 33.8 mM pH of the dialysis composition 3.0 Total amount citrate 1.75 mM 78.8 mM Content of citric acid (% of total 57 concentration of citrate) Precipitation observed directly after preparation.

Example 21

(85) TABLE-US-00023 Diluted Concentrate Ingredient: solution (1:45) Sodium chloride (NaCl) 100 mM 4500 mM Potassium chloride (KCl) 3.0 mM 135 mM Magnesium Chloride 0.50 mM 22.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 45.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.25 mM 56.3 mM Citric acid (anhydrous) 1.25 mM 56.3 mM Citrate (trisodium citrate) 0.50 mM 22.5 mM pH of the dialysis composition 2.5 Total amount citrate 1.75 mM 67.5 mM Content of citric acid (% of total 71 concentration of citrate) The solution was stored at 40 degrees Celsius. Precipitation observed after 4 days.

Example 22

(86) TABLE-US-00024 Diluted Concentrate Ingredient: solution (1:45) Sodium chloride (NaCl) 100 mM 4500 mM Potassium chloride (KCl) 3.0 mM 135 mM Magnesium Chloride 0.50 mM 22.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 45.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.25 mM 56.3 mM Citric acid (anhydrous) 1.25 mM 56.3 mM Citrate (trisodium citrate) 0.75 mM 33.8 mM pH of the dialysis composition 2.8 Total amount citrate 2.00 mM 90.0 mM Content of citric acid (% of total 63 concentration of citrate) Precipitation observed directly after preparation of solution.

Example 23

(87) TABLE-US-00025 Diluted Concentrate Ingredient: solution (1:45) Sodium chloride (NaCl) 100 mM 4500 Mm Potassium chloride (KCl) 3.0 mM 135 mM Magnesium Chloride 0.50 mM 22.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 45.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.25 mM 56.3 mM Citric acid (anhydrous) 1.50 mM 67.5 mM Citrate (trisodium citrate) 0.50 mM 22.5 mM pH of the dialysis composition 2.2 Total amount citrate 2.00 mM 90.0 mM Content of citric acid (% of total 75 concentration of citrate) The solution was stored at 40 degrees Celsius. Precipitation observed after after 4.5 months. Contamination of sample is not excluded.

Example 24

(88) TABLE-US-00026 Diluted Concentrate Ingredient: solution (1:45) Sodium chloride (NaCl) 100 mM 4500 mM Potassium chloride (KCl) 3.0 mM 135 mM Magnesium Chloride 0.50 mM 22.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 45.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.4 mM .sup.63 mM Citric acid (anhydrous) 1.0 mM .sup.45 mM Citrate (trisodium citrate) .sup.0 mM 0 mM pH of the dialysis composition 1.29 Total amount citrate 1.0 mM 45.0 mM Content of citric acid (% of total 100 concentration of citrate)

Example 25

(89) TABLE-US-00027 Diluted Concentrate Ingredient: solution (1:45) Sodium chloride (NaCl) 100 mM 4500 mM Potassium chloride (KCl) 3.0 mM 135 mM Magnesium Chloride 0.50 mM 22.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 45.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.44 mM 64.7 mM Citric acid (anhydrous) 1 mM 45.0 mM Citrate (trisodium citrate) 0.25 mM 11.3 mM pH of the dialysis composition 2.21 Total amount citrate 1.25 mM 66.3 mM Content of citric acid (% of total 80 concentration of citrate)

Example 26

(90) TABLE-US-00028 Diluted Concentrate Ingredient: solution (1:45) Sodium chloride (NaCl) 100 mM 4500 mM Potassium chloride (KCl) 3.0 mM 135 mM Magnesium Chloride 0.50 mM 22.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 45.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.48 mM 66.4 mM Citric acid (anhydrous) 1.25 mM 56.3 mM Citrate (trisodium citrate) 0.25 mM 11.2 mM pH of the dialysis composition 2.07 Total amount citrate 1.50 mM 67.5 mM Content of citric acid (% of total 83 concentration of citrate)

Example 27

(91) TABLE-US-00029 Diluted Concentrate Ingredient: solution (1:45) Sodium chloride (NaCl) 100 mM 4500 mM Potassium chloride (KCl) 3.0 mM 135 mM Magnesium Chloride 0.50 mM 22.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 45.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.51 mM 68.1 mM Citric acid (anhydrous) 1.50 mM 67.5 mM Citrate (trisodium citrate) 0.25 mM 11.2 mM pH of the dialysis composition 1.96 Total amount citrate 1.75 mM 78.7 mM Content of citric acid (% of total 86 concentration of citrate)

Example 28

(92) TABLE-US-00030 Diluted Concentrate Ingredient: solution (1:45) Sodium chloride (NaCl) 100 mM 4500 mM Potassium chloride (KCl) 3.0 mM 135 mM Magnesium Chloride 0.50 mM 22.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 45.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.55 mM 69.8 mM Citric acid (anhydrous) 1.50 mM 67.5 mM Citrate (trisodium citrate) 0.50 mM 22.5 mM pH of the dialysis composition 2.24 Total amount citrate 2.00 mM 90.0 mM Content of citric acid (% of total 75 concentration of citrate)

Example 29

(93) TABLE-US-00031 Diluted Concentrate Ingredient: solution (1:45) Sodium chloride (NaCl) 102 mM 4604 mM Potassium chloride (KCl) 4.0 mM 180 mM Magnesium Chloride 0.50 mM 22.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 45.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.75 mM 78.8 mM Citric acid (anhydrous) 0.75 mM 33.8 mM Citrate (trisodium citrate) 0.25 mM 11.2 mM pH of the dialysis composition 2.37 Total amount citrate 1.0 mM 45.0 mM Content of citric acid (% of total 75 concentration of citrate)

Example 30

(94) TABLE-US-00032 Diluted Concentrate Ingredient: solution (1:45) Sodium chloride (NaCl) 102 mM 4608 mM Potassium chloride (KCl) 4.0 mM 180 mM Magnesium Chloride 0.50 mM 22.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 45.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.75 mM 78.8 mM Citric acid (anhydrous) 0.80 mM 36.0 mM Citrate (trisodium citrate) 0.20 mM 9.0 mM pH of the dialysis composition 2.18 Total amount citrate 1.0 mM 45.0 mM Content of citric acid (% of total 80 concentration of citrate)

Example 31

(95) TABLE-US-00033 Diluted Concentrate Ingredient: solution (1:45) Sodium chloride (NaCl) 103 mM 4615 mM Potassium chloride (KCl) 4.0 mM 180 mM Magnesium Chloride 0.50 mM 22.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 45.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.75 mM 78.8 mM Citric acid (anhydrous) 0.85 mM 38.2 mM Citrate (trisodium citrate) 0.15 mM 6.8 mM pH of the dialysis composition 2.06 Total amount citrate 1.0 mM 45.0 mM Content of citric acid (% of total 85 concentration of citrate)

Example 32

(96) TABLE-US-00034 Diluted Concentrate Ingredient: solution (1:45) Sodium chloride (NaCl) 103 mM 4622 mM Potassium chloride (KCl) 4.0 mM 180 mM Magnesium Chloride 0.50 mM 22.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 45.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.75 mM 78.8 mM Citric acid (anhydrous) 0.90 mM 40.5 mM Citrate (trisodium citrate) 0.10 mM 4.5 mM pH of the dialysis composition 1.77 Total amount citrate 1.0 mM 45.0 mM Content of citric acid (% of total 90 concentration of citrate)

Example 33

(97) TABLE-US-00035 Diluted Concentrate Ingredient: solution (1:35) Sodium chloride (NaCl) 102 mM 3584 mM Potassium chloride (KCl) 3.0 mM 105 mM Magnesium Chloride 0.50 mM 17.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (monohydrate) 1.1 g/l.sup. 38.5 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.40 mM 49.0 mM Citric acid (monohydrate) 0.80 mM 35.0 mM Citrate (trisodium citrate) 0.20 mM 0 mM pH of the dialysis composition 2.4 Total amount citrate 1.00 mM 35.0 mM Content of citric acid (% of total 80 concentration of citrate)

Example 34

(98) TABLE-US-00036 Diluted Concentrate Ingredient: solution (1:35) Sodium chloride (NaCl) 102 mM 3580 mM Potassium chloride (KCl) 3.0 mM 105 mM Magnesium Chloride 0.50 mM 17.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (monohydrate) 1.1 g/l.sup. 38.5 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.44 mM 50.3 mM Citric acid (monohydrate) 1.00 mM .sup.35 mM Citrate (trisodium citrate) 0.25 mM 8.8 mM pH of the dialysis composition 2.4 Total amount citrate 1.25 mM 43.8 mM Content of citric acid (% of total 80 concentration of citrate)

Example 35

(99) TABLE-US-00037 Diluted Concentrate Ingredient: solution (1:35) Sodium chloride (NaCl) 102 mM 3570 mM Potassium chloride (KCl) 3.0 mM 105 mM Magnesium Chloride 0.50 mM 17.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (monohydrate) 1.1 g/l.sup. 38.5 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.48 mM 51.6 mM Citric acid (monohydrate) 1.20 mM .sup.42 mM Citrate (trisodium citrate) 0.30 mM 10.5 mM pH of the dialysis composition 2.3 Total amount citrate 1.50 mM 52.5 mM Content of citric acid (% of total 80 concentration of citrate)

Example 36

(100) TABLE-US-00038 Diluted Concentrate Ingredient: solution (1:35) Sodium chloride (NaCl) 102 mM 3570 mM Potassium chloride (KCl) 3.0 mM 105 mM Magnesium Chloride 0.50 mM 17.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (monohydrate) 1.1 g/l.sup. 38.5 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.51 mM 52.9 mM Citric acid (monohydrate) 1.40 mM .sup.49 mM Citrate (trisodium citrate) 0.35 mM 12.3 mM pH of the dialysis composition 2.3 Total amount citrate 1.75 mM 61.3 mM Content of citric acid (% of total 80 concentration of citrate)

Example 37

(101) TABLE-US-00039 Diluted Concentrate Ingredient: solution (1:35) Sodium chloride (NaCl) 102 mM 3560 mM Potassium chloride (KCl) 3.0 mM 105 mM Magnesium Chloride 0.50 mM 17.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (monohydrate) 1.1 g/l.sup. 38.5 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.55 mM 54.3 mM Citric acid (monohydrate) 1.60 mM 56.0 mM Citrate (trisodium citrate) 0.40 mM 14.0 mM pH of the dialysis composition 2.5 Total amount citrate 2.00 mM 70.0 mM Content of citric acid (% of total 80 concentration of citrate)

Example 38

(102) TABLE-US-00040 Diluted Concentrate Ingredient: solution (1:35) Sodium chloride (NaCl) 102 mM 3550 mM Potassium chloride (KCl) 3.0 mM 105 mM Magnesium Chloride 0.50 mM 17.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (monohydrate) 1.1 g/l.sup. 38.5 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.59 mM 55.6 mM Citric acid (monohydrate) 1.75 mM 61.3 mM Citrate (trisodium citrate) 0.50 mM 17.5 mM pH of the dialysis composition 2.4 Total amount citrate 2.25 mM 78.8 mM Content of citric acid (% of total 78 concentration of citrate)

Example 39

(103) TABLE-US-00041 Diluted Concentrate Ingredient: solution (1:45) Sodium chloride (NaCl) 102 mM 4610 mM Potassium chloride (KCl) 3.0 mM 135 mM Magnesium Chloride 0.50 mM 22.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 45.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.40 mM 63.0 mM Citric acid (anhydrous) 0.80 mM 36.0 mM Citrate (trisodium citrate) 0.20 mM 9 mM pH of the dialysis composition 2.23 Total amount citrate 1.00 mM 45.0 mM Content of citric acid (% of total 80 concentration of citrate)

Example 40

(104) TABLE-US-00042 Diluted Concentrate Ingredient: solution (1:45) Sodium chloride (NaCl) 102 mM 4600 mM Potassium chloride (KCl) 3.0 mM 135 mM Magnesium Chloride 0.50 mM 22.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 45.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.44 mM 64.8 mM Citric acid (anhydrous) 1.00 mM .sup.45 mM Citrate (trisodium citrate) 0.25 mM 11.2 mM pH of the dialysis composition 2.22 Total amount citrate 1.25 mM 56.2 mM Content of citric acid (% of total 80 concentration of citrate)

Example 41

(105) TABLE-US-00043 Diluted Concentrate Ingredient: solution (1:45) Sodium chloride (NaCl) 102 mM 4590 mM Potassium chloride (KCl) 3.0 mM 135 mM Magnesium Chloride 0.50 mM 22.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. .sup.45 g/l Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.48 mM 66.6 mM Citric acid (anhydrous) 1.20 mM .sup.54 mM Citrate (trisodium citrate) 0.30 mM 13.5 mM pH of the dialysis composition 2.23 Total amount citrate 1.50 mM 67.5 mM Content of citric acid (% of total 80 concentration of citrate)

Example 42

(106) TABLE-US-00044 Diluted Concentrate Ingredient: solution (1:45) Sodium chloride (NaCl) 102 mM 4590 mM Potassium chloride (KCl) 3.0 mM 135 mM Magnesium Chloride 0.50 mM 22.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 45.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.51 mM 67.95 mM Citric acid (anhydrous) 1.40 mM 63.0 mM Citrate (trisodium citrate) 0.35 mM 15.8 mM pH of the dialysis composition 2.22 Total amount citrate 1.75 mM 78.8 mM Content of citric acid (% of total 80 concentration of citrate)

Example 43

(107) TABLE-US-00045 Diluted Concentrate Ingredient: solution (1:45) Sodium chloride (NaCl) 102 mM 4580 mM Potassium chloride (KCl) 3.0 mM 135 mM Magnesium Chloride 0.50 mM 22.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 45.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.55 mM 69.8 mM Citric acid (anhydrous) 1.60 mM 72.0 mM Citrate (trisodium citrate) 0.40 mM 18.0 mM pH of the dialysis composition 2.21 Total amount citrate 2.00 mM 90.0 mM Content of citric acid (% of total 80 concentration of citrate)

Example 44

(108) TABLE-US-00046 Diluted Concentrate Ingredient: solution (1:45) Sodium chloride (NaCl) 101 mM 4570 mM Potassium chloride (KCl) 3.0 mM 135 mM Magnesium Chloride 0.50 mM 22.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 45.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.70 mM 76.5 mM Citric acid (anhydrous) 2.4 mM 108 mM Citrate (trisodium citrate) 0.6 mM 27 mM pH of the dialysis composition 2.2 Total amount citrate 3.0 mM 135 mM Content of citric acid (% of total 80 concentration of citrate)

Example 45

(109) TABLE-US-00047 Diluted Concentrate Ingredient: solution (1:45) Sodium chloride (NaCl) 101 mM 4550 mM Potassium chloride (KCl) 3.0 mM 135 mM Magnesium Chloride 0.50 mM 22.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 45.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.70 mM 76.5 mM Citric acid (anhydrous) 2.4 mM 108 mM Citrate (trisodium citrate) 0.60 mM 27 mM pH of the dialysis composition 2.2 Total amount citrate 3.0 mM 135 mM Content of citric acid (% of total 80 concentration of citrate)

Example 46

(110) TABLE-US-00048 Diluted Concentrate Ingredient: solution (1:45) Sodium chloride (NaCl) 101 mM 4530 mM Potassium chloride (KCl) 3.0 mM 135 mM Magnesium Chloride 0.50 mM 22.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 45.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.85 mM 83.2 mM Citric acid (anhydrous) 3.2 mM 144 mM Citrate (trisodium citrate) 0.80 mM 36 mM pH of the dialysis composition 2.1 Total amount citrate 4.0 mM 108 mM Content of citric acid (% of total 80 concentration of citrate)

Example 47

(111) TABLE-US-00049 Diluted Concentrate Ingredient: solution (1:45) Sodium chloride (NaCl) 100 mM 4500 mM Potassium chloride (KCl) 3.0 mM 135 mM Magnesium Chloride 0.50 mM 22.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 45.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 2.00 mM 90.0 mM Citric acid (anhydrous) 4.0 mM 180 mM Citrate (trisodium citrate) 1.0 mM 45 mM pH of the dialysis composition 2.2 Total amount citrate 5.0 mM 225 mM Content of citric acid (% of total 80 concentration of citrate)

Example 48

(112) TABLE-US-00050 Diluted Concentrate Ingredient: solution (1:45) Sodium chloride (NaCl) 99.4 mM 4470 mM Potassium chloride (KCl) 3.0 mM 135 mM Magnesium Chloride 0.50 mM 22.5 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 45.0 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 2.15 mM 96.75 mM.sup. Citric acid (anhydrous) 4.8 mM 216 mM Citrate (trisodium citrate) 1.2 mM 54 mM pH of the dialysis composition 2.1 Total amount citrate 6.0 mM 270 mM Content of citric acid (% of total 80 concentration of citrate)

Example 49

(113) TABLE-US-00051 Diluted Concentrate Ingredient: solution (1:200) Potassium chloride (KCl) 3.0 mM 600 mM Magnesium Chloride 0.50 mM 100 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 200 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.51 mM 303 mM Citric acid (anhydrous) 1.5 mM 300 mM Citrate (trisodium citrate) 0.25 mM 50 mM pH of the dialysis composition 2.1 Total amount citrate 1.75 mM 350 mM Content of citric acid (% of total 86 concentration of citrate)

Example 50

(114) TABLE-US-00052 Diluted Concentrate Ingredient: solution (1:200) Potassium chloride (KCl) 3.0 mM 600 mM Magnesium Chloride 0.50 mM 100 mM Hexahydrate(MgCl.sub.2*6H.sub.2O) Glucose (anhydrous) 1.0 g/l.sup. 200 g/l.sup. Calciumchloride dihydrate (CaCl.sub.2*2H.sub.2O) 1.55 mM 310 mM Citric acid (anhydrous) 1.6 mM 320 mM Citrate (trisodium citrate) 0.4 mM 80 mM pH of the dialysis composition (calculated) 2.2 Total amount citrate 2.0 mM 400 mM Content of citric acid (% of total 80 concentration of citrate)

(115) Solutions prepared according to Examples 1 to 12 are intended for dilution 135. They were stored in 402 degrees Celsius, and 302 degrees Celsius, respectively. Precipitation was observed in Example 8.

(116) The solutions prepared according to Examples 13 to 16 were intended for dilution according to 145. The concentrated solutions were stored at 402 degrees Celsius, and 302 degrees Celsius, respectively during one month. No precipitation was observed.

(117) Examples 17 to 23 were prepared for dilution according to 145. The concentrated solutions were stored at room temperature and 402 degrees Celsius, respectively. Precipitation was observed in these examples.

(118) The solutions according to Examples 24 to 28 were intended for dilution according to 145. The concentrated solutions were stored at 302 degrees Celsius, and at 402 degrees Celsius, respectively during two months. No precipitation was observed.

(119) Also the concentrates according to Examples 29 to 32 are intended for dilution 145.

(120) Acid concentrates for dilution 135 were prepared according to Examples 33 to 38. Of those, acid concentrates according to Examples 33, 36 and 38 were stored under accelerated ageing conditions at 402 C. in an atmosphere with 755% RH. No precipitations were found.

(121) Acid concentrates for dilution 145 were prepared according to Examples 39 to 48.

(122) An acid concentrate for dilution 1200 was prepared according to Example 49.

(123) The acid concentrate 49 was stored at 302 C. during 30 days. No precipitation was found.

(124) If not otherwise specified, the acid concentrates above stored at 30 degrees Celsius were kept in an atmosphere with 655% RH, while the acid concentrates stored at 40 degrees Celsius were kept in an atmosphere with 405% RH.

(125) Test of pH Stability

(126) pH measurement were performed of concentrated solutions according to Examples 1-6 and 8-9. The results are presented in Table 1. The solutions according to Examples 1-6 and 8-9 were stored in glass bottles in a temperature of 40 degrees Celsius. The pH values of the solutions were measured during a time period of four weeks.

(127) TABLE-US-00053 TABLE 1 Solution pH after 1 pH after 2 pH after 3 pH after 4 according pH at day week weeks weeks weeks to: 0 storage storage storage storage Example 1 1.55 1.55 1.57 1.55 Example 2 1.50 1.50 1.59 1.49 1.5 Example 3 2.33 2.33 2.38 2.32 2.38 Example 4 2.22 2.23 2.21 2.21 2.28 Example 5 2.12 2.15 2.12 2.11 2.17 Example 6 2.53 2.55 2.54 2.53 2.59 Example 8 2.82 2.83 Finished Finished Finished precipitation Example 9 2.50 2.40

(128) The acid concentrate dialysis compositions are intended to be diluted to suitable concentration. For example, the concentrated acid dialysis compositions are diluted according to 1 part dialysis composition+34 parts water (total 35 parts) water (135), alternatively 1 part with 44 parts water 145).

(129) The water is of quality suitable for dialysis, either available as tap water or purified in water cleaning systems into water having quality suitable for dialysis.

(130) The acid dialysis compositions were mixed with a base composition comprising bicarbonate (sodium bicarbonate, NaHCO.sub.3).

(131) However, all these dialysis fluids, both acetate and citrate containing dialysis fluids, further contain about 130-150 mM sodium, 135-145 mM sodium or 140 mM sodium, and 20-40 mM bicarbonate, 25-35 mM bicarbonate or 34 mM bicarbonate, and chloride determined by electro-neutrality.

(132) While the invention has been described in connection with what is presently considered to be the most practical and preferred embodiments, it is to be understood that the invention is not to be limited to the disclosed embodiments, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and the scope of the appended claims.