{"id":16538,"date":"2025-10-20T18:10:28","date_gmt":"2025-10-20T11:10:28","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=16538"},"modified":"2025-10-20T18:14:12","modified_gmt":"2025-10-20T11:14:12","slug":"haemodialysis-solutions","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/haemodialysis-solutions\/","title":{"rendered":"Haemodialysis Solutions"},"content":{"rendered":"

BP 2025 (Ph. Eur. 11.6 update)<\/p>\n

DEFINITION<\/h2>\n
Solutions of electrolytes with a concentration close to the electrolytic composition of plasma. Glucose may be included in the formulation.
\nBecause of the large volumes used, haemodialysis solutions are usually prepared by diluting a concentrated solution with water of suitable quality (see the monograph Haemodialysis solutions, concentrated, water for diluting (1167)), using for example an automatic dosing device.<\/p>\n

CONCENTRATED SOLUTIONS FOR HAEMODIALYSIS<\/h2>\n
Concentrated haemodialysis solutions are prepared and stored using materials and methods designed to produce solutions having as low a degree of microbial contamination as possible. In certain circumstances, it may be necessary to use sterile solutions.
\nDuring dilution and use, precautions are taken to avoid microbial contamination. Diluted solutions are to be used immediately after preparation.<\/p>\n
Concentrated solutions for haemodialysis are supplied in:
\n\u2014 rigid, semi-rigid or flexible plastic containers;
\n\u2014 glass containers.<\/p>\n
3 types of concentrated solutions are used:<\/p>\n
1. Concentrated solutions with acetate or lactate<\/strong>
\nSeveral formulations of concentrated solutions are used. The concentrations of the components in the solutions are such that, after dilution to the stated volume, the concentrations of the components per litre are usually in the following ranges (see Table 0128.-1):<\/p>\n
Table 0128.-1.<\/p>\n\n\n\n\n\n\n\n\n\n\n\n
<\/td>\n Concentration
\n(mmol\/L)<\/td>\n Concentration
\n(mEq\/L)<\/td>\n<\/tr>\n
Sodium<\/td>\n 130 – 145<\/td>\n 130 – 145<\/td>\n<\/tr>\n
Potassium<\/td>\n 0 – 3.0<\/td>\n 0 – 3.0<\/td>\n<\/tr>\n
Calcium<\/td>\n 0 – 2.0<\/td>\n 0 – 4.0<\/td>\n<\/tr>\n
Magnesium<\/td>\n 0 – 1.2<\/td>\n 0 – 2.4<\/td>\n<\/tr>\n
Acetate or lactate<\/td>\n 32 – 45<\/td>\n 32 – 45<\/td>\n<\/tr>\n
<\/td>\n Concentration
\n(mmol\/L)<\/td>\n Concentration
\n(mEq\/L)<\/td>\n<\/tr>\n
Chloride<\/td>\n 90 – 120<\/td>\n 90 – 120<\/td>\n<\/tr>\n
Glucose<\/td>\n 0 – 12.0<\/td>\n <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
Concentrated solutions with acetate or lactate are diluted before use.<\/p>\n
2. Concentrated acid solutions<\/strong><\/p>\n
Several formulations of concentrated solutions are used. The concentrations of the components in the solutions are such that, after dilution to the stated volume and before neutralisation with sodium hydrogen carbonate, the concentrations of the components per litre are usually in the following ranges (see Table 0128.-2):<\/p>\n
Table 0128.-2.<\/p>\n\n\n\n\n\n\n\n\n\n\n
<\/td>\n Concentration
\n(mmol\/L)<\/td>\n Concentration
\n(mEq\/L)<\/td>\n<\/tr>\n
Sodium<\/td>\n 80 – 110<\/td>\n 80 – 110<\/td>\n<\/tr>\n
Potassium<\/td>\n 0 – 3.0<\/td>\n 0 – 3.0<\/td>\n<\/tr>\n
Calcium<\/td>\n 0 – 2.0<\/td>\n 0 – 4.0<\/td>\n<\/tr>\n
Magnesium<\/td>\n 0 – 1.2<\/td>\n 0 – 2.4<\/td>\n<\/tr>\n
Acetic acid<\/td>\n 2.5 – 10<\/td>\n 2.5 – 10<\/td>\n<\/tr>\n
Chloride<\/td>\n 90 – 120<\/td>\n 90 – 120<\/td>\n<\/tr>\n
Glucose<\/td>\n 0 – 12.0<\/td>\n <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
Sodium hydrogen carbonate must be added immediately before use to a final concentration of not more than 45 mmol\/L.<\/p>\n
The concentrated solution of sodium hydrogen carbonate is supplied in a separate container. The concentrated acid solutions and the concentrated solutions of sodium hydrogen carbonate are diluted and mixed immediately before use using a suitable device. Alternatively, sodium hydrogen carbonate in powder form may be used to prepare the solution.<\/p>\n
3. Concentrated solutions without buffer<\/strong>
\nSeveral formulations of concentrated solutions without buffer are used. The concentrations of the components in the solutions are such that, after dilution to the stated volume, the concentrations of the components per litre are usually in the following ranges (see Table 0128.-3):<\/p>\n
Table 0128.-3.<\/p>\n\n\n\n\n\n\n\n\n\n
<\/td>\n Concentration
\n(mmol\/L)<\/td>\n Concentration
\n(mEq\/L)<\/td>\n<\/tr>\n
Sodium<\/td>\n 130 – 145<\/td>\n 130 – 145<\/td>\n<\/tr>\n
Potassium<\/td>\n 0 – 3.0<\/td>\n 0 – 3.0<\/td>\n<\/tr>\n
Calcium<\/td>\n 0 – 2.0<\/td>\n 0 – 4.0<\/td>\n<\/tr>\n
Magnesium<\/td>\n 0 – 1.2<\/td>\n 0 – 2.4<\/td>\n<\/tr>\n
Chloride<\/td>\n 130 – 155<\/td>\n 130 – 155<\/td>\n<\/tr>\n
Glucose<\/td>\n 0 – 12.0<\/td>\n <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
Concentrated solutions without buffer are used together with parenteral administration of suitable hydrogen carbonate solutions.<\/p>\n
The following tests are carried out on the diluted, ready-to-use solutions.<\/p>\n
IDENTIFICATION<\/h2>\n
According to the stated composition, the solution to be examined gives the following identification reactions (2.3.1):
\n\u2014 potassium: reaction (b);
\n\u2014 calcium: reaction (a);
\n\u2014 sodium: reaction (b);
\n\u2014 chlorides: reaction (a);
\n\u2014 lactates;
\n\u2014 carbonates and hydrogen carbonates;
\n\u2014 acetates:
\n\u2014 if the solution is free from glucose, use reaction (b);
\n\u2014 if the solution contains glucose, use the following method: to 5 mL of the solution to be examined add 1 mL of hydrochloric acid R in a test-tube fitted with a stopper and a bent tube, heat and collect a few millilitres of distillate; carry out reaction (b) of acetates on the distillate;
\n\u2014 magnesium: to 0.1 mL of titan yellow solution R add 10 mL of water R, 2 mL of the solution to be examined and 1 mL of a 4.2 g\/L solution of sodium hydroxide R; a pink colour is produced;
\n\u2014 glucose: to 5 mL of the solution to be examined add 2 mL of dilute sodium hydroxide solution R and 0.05 mL of copper sulfate solution R; the solution is blue and clear; heat to boiling; an abundant red precipitate is formed.<\/p>\n
TESTS<\/h2>\n
Appearance of solution<\/strong><\/p>\n
The solution to be examined is clear (2.2.1). If it does not contain glucose, it is colourless (2.2.2, Method I). If it contains glucose, it is not more intensely coloured than reference solution Y7 (2.2.2, Method I).<\/p>\n
Aluminium<\/strong><\/p>\n
Maximum 10 \u03bcg\/L.
\nAtomic absorption spectrometry (2.2.23, Method I or II). Use a matrix modifier (for example, nitric acid R and magnesium nitrate R in water R) in the same quantity for the test solution, the reference solutions and the blank solution.
\nTest solution If necessary, dilute the solution to be examined with water R to a concentration suitable for the instrument to be used.
\nReference solutions. Method I \u2013 direct calibration.
\nPrepare the reference solutions by diluting, for example aluminium standard solution (10 ppm Al) R with acidified water R.
\nReference solutions. Method II \u2013 standard additions.
\nPrepare at least 3 reference solutions in the test solution, in a range spanning the expected aluminium concentration of the test solution, for example by diluting aluminium standard solution (10 ppm Al) R with the test solution.
\nBlank solution water R.
\nSource Aluminium hollow-cathode lamp.
\nWavelength 309.3 nm.
\nAtomisation device Graphite furnace.<\/p>\n
Extractable volume (2.9.17)<\/strong><\/p>\n
The volume measured is not less than the nominal volume stated on the label.<\/p>\n
Microbial contamination<\/strong><\/p>\n
TAMC: acceptance criterion 10 CFU\/mL (2.6.12). Sterility (2.6.1)
\nIf the label states that the concentrated haemodialysis solution is sterile, it complies with the test for sterility.<\/p>\n
Bacterial endotoxins (2.6.14)<\/strong><\/p>\n
Less than 0.25 IU\/mL in the solution diluted for use.<\/p>\n
Pyrogens (2.6.8)<\/strong>
\nSolutions for which a validated test for bacterial endotoxins cannot be carried out comply with the test for pyrogens. Dilute the solution to be examined with water for injections R to the concentration prescribed for use. Inject 10 mL of the solution per kilogram of the rabbit’s mass.<\/p>\n
ASSAY<\/h2>\n
Determine the density (2.2.5) of the concentrated solution and calculate the content in grams per litre and in millimoles per
\nlitre.<\/p>\n
Sodium<\/strong><\/p>\n
97.5 per cent to 102.5 per cent of the content of sodium (Na) stated on the label.
\nAtomic emission spectrometry (2.2.22, Method I).
\nTest solution If necessary, dilute the solution to be examined with water R to a concentration suitable for the instrument to be used.
\nReference solutions Prepare the reference solutions using sodium standard solution (200 ppm Na) R.
\nWavelengths 589.0 nm or 589.6 nm (sodium emits as a doublet).<\/p>\n
Potassium<\/strong><\/p>\n
95.0 per cent to 105.0 per cent of the content of potassium (K) stated on the label.
\nAtomic absorption spectrometry (2.2.23, Method I).
\nTest solution Dilute with water R an accurately weighed quantity of the solution to be examined to a concentration suitable for the instrument to be used. To 100 mL of this solution add 10 mL of a 22 g\/L solution of sodium chloride R.
\nReference solutions Prepare the reference solutions using potassium standard solution (100 ppm K) R. To 100 mL of each reference solution add 10 mL of a 22 g\/L solution of sodium chloride R.
\nSource Potassium hollow-cathode lamp.
\nWavelength 766.5 nm.
\nAtomisation device Air-acetylene flame.<\/p>\n
Calcium<\/strong><\/p>\n
95.0 per cent to 105.0 per cent of the content of calcium (Ca) stated on the label.
\nAtomic absorption spectrometry (2.2.23, Method I).<\/p>\n
Test solution Dilute 5.0 mL of the solution to be examined to 100.0 mL with water R. To 3.0 mL of this solution add 5 mL of lanthanum chloride solution R and dilute to 50.0 mL with water R.
\nReference solutions Into 4 identical volumetric flasks each containing 5 mL of lanthanum chloride solution R, introduce respectively 2.5 mL, 5.0 mL, 7.0 mL and 10.0 mL of calcium standard solution (10 ppm Ca) R and dilute to 50.0 mL with water R.
\nSource Calcium hollow-cathode lamp.
\nWavelength 422.7 nm.
\nAtomisation device Air-acetylene flame.<\/p>\n
Magnesium<\/strong><\/p>\n
95.0 per cent to 105.0 per cent of the content of magnesium (Mg) stated on the label.
\nAtomic absorption spectrometry (2.2.23, Method I).
\nTest solution Dilute 5.0 mL of the solution to be examined to 100.0 mL with water R. To 2.0 mL of this solution add 5 mL of lanthanum chloride solution R and dilute to 50.0 mL with water R.
\nReference solutions Into 4 identical volumetric flasks each containing 5 mL of lanthanum chloride solution R, introduce respectively 1.0 mL, 2.0 mL, 3.0 mL and 4.0 mL of magnesium standard solution (10 ppm Mg) R and dilute to 50.0 mL with water R.
\nSource Magnesium hollow-cathode lamp.<\/p>\n
Wavelength 285.2 nm.
\nAtomisation device Air-acetylene flame.<\/p>\n
Total chloride<\/strong><\/p>\n
95.0 per cent to 105.0 per cent of the content of chloride (Cl) stated on the label.
\nDilute an accurately measured volume of the solution to be examined containing the equivalent of about 0.68 mEq of chloride with an appropriate volume of water R in order to immerse the electrode. Carry out a potentiometric titration (2.2.20), using 0.1 M silver nitrate. Read the volume added between the 2 points of inflexion.
\n1 mL of 0.1 M silver nitrate is equivalent to 3.545 mg of Cl.<\/p>\n
Acetate<\/strong><\/p>\n
95.0 per cent to 105.0 per cent of the content of acetate stated on the label.
\nTo a volume of the solution to be examined, corresponding to about 0.7 mmol of acetate, add 10.0 mL of 0.1 M hydrochloric acid. Carry out a potentiometric titration (2.2.20), using 0.1 M sodium hydroxide. Read the volume added between the 2 points of inflexion.
\n1 mL of 0.1 M sodium hydroxide is equivalent to 0.1 mmol of acetate.<\/p>\n
Lactate<\/strong><\/p>\n
95.0 per cent to 105.0 per cent of the content of lactate stated on the label.
\nTo a volume of the solution to be examined, corresponding to about 0.7 mmol of lactate, add 10.0 mL of 0.1 M hydrochloric acid. Then add 50 mL of acetonitrile R. Carry out a potentiometric titration (2.2.20), using 0.1 M sodium hydroxide. Read the volume added between the 2 points of inflexion.
\n1 mL of 0.1 M sodium hydroxide is equivalent to 0.1 mmol of lactate.<\/p>\n
Sodium hydrogen carbonate<\/strong><\/p>\n
95.0 per cent to 105.0 per cent of the content of sodium hydrogen carbonate stated on the label.<\/p>\n
Titrate with 0.1 M hydrochloric acid a volume of the solution to be examined corresponding to about 0.1 g of sodium hydrogen carbonate, determining the end-point potentiometrically (2.2.20).<\/p>\n
1 mL of 0.1 M hydrochloric acid is equivalent to 8.40 mg of NaHCO3.<\/p>\n
Reducing sugars<\/strong><\/p>\n
(expressed as glucose): 95.0 per cent to 105.0 per cent of the content of glucose stated on the label.
\nTransfer a volume of the solution to be examined containing the equivalent of 25 mg of glucose to a 250 mL conical flask with a ground-glass neck and add 25.0 mL of cupri-citric solution R. Add a few grains of pumice, fit a reflux condenser, heat so that boiling occurs within 2 min and maintain boiling for exactly 10 min. Cool and add 3 g of potassium iodide R dissolved in 3 mL of water R. Carefully add, in small amounts, 25 mL of a 25 per cent m\/m solution of sulfuric acid R.
\nTitrate with 0.1 M sodium thiosulfate using starch solution R, added towards the end of the titration, as indicator. Carry out a blank titration using 25.0 mL of water R.
\nCalculate the content of reducing sugars, expressed as glucose (C_{6<\/sub>H_{12<\/sub>O_{6<\/sub>), using Table 0128.-4.<\/p>\n}}}
Table 0128.-4.<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n
Volume of 0.1 M sodium thiosulfate (mL)<\/td>\n Glucose
\n(mg)<\/td>\n<\/tr>\n
8<\/td>\n 19.8<\/td>\n<\/tr>\n
9<\/td>\n 22.4<\/td>\n<\/tr>\n
10<\/td>\n 25.0<\/td>\n<\/tr>\n
11<\/td>\n 27.6<\/td>\n<\/tr>\n
12<\/td>\n 30.3<\/td>\n<\/tr>\n
13<\/td>\n 33.0<\/td>\n<\/tr>\n
14<\/td>\n 35.7<\/td>\n<\/tr>\n
15<\/td>\n 38.5<\/td>\n<\/tr>\n
16<\/td>\n 41.3<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
STORAGE<\/h2>\n
At 4 \u00b0C or above.<\/p>\n
LABELLING<\/h2>\n
\u2014 The label states:<\/p>\n
\u2014 the formula of the concentrated solution for haemodialysis expressed in grams per litre and in millimoles per litre;<\/p>\n
\u2014 the nominal volume of the solution in the container;<\/p>\n
\u2014 where applicable, that the concentrated solution is sterile;<\/p>\n
\u2014 the storage conditions;<\/p>\n
\u2014 that the concentrated solution is to be diluted immediately before use;<\/p>\n
\u2014 the dilution to be made;<\/p>\n
\u2014 that the volume taken for use is to be measured accurately;<\/p>\n
\u2014 the ionic formula for the diluted solution ready for use in millimoles per litre;<\/p>\n
\u2014 that any unused portion of solution is to be discarded;<\/p>\n
\u2014 where applicable, that sodium hydrogen carbonate is to be added before use;<\/p>\n
\u2014 that the solution is not to be used for intraveneous infusion.<\/p>\n","protected":false},"excerpt":{"rendered":"
BP 2025 (Ph. Eur. 11.6 update) DEFINITION Solutions of electrolytes with a concentration close to the electrolytic composition of plasma. Glucose may be included in the formulation. Because of the large volumes used, haemodialysis solutions are usually prepared by diluting a concentrated solution with water of suitable quality (see the monograph Haemodialysis solutions, concentrated, water…<\/p>\n","protected":false},"author":5,"featured_media":16541,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-16538","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-formulated-preparations-specific-monographs"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16538","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=16538"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16538\/revisions"}],"predecessor-version":[{"id":16548,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16538\/revisions\/16548"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/16541"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=16538"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=16538"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=16538"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

STORAGE<\/h2>\nAt 4 \u00b0C or above.<\/p>\n

STORAGE<\/h2>\n
At 4 \u00b0C or above.<\/p>\n