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The unit of osmolality is osmole per kilogram (osmol/kg), but the submultiple milliosmole per kilogram (mosmol/kg) is usually used.
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EUROPEAN PHARMACOPOEIA 7.3 2.2.35. Osmolality
Osmolality is a practical means of giving an overall measure of the contribution of the various solutes present in a solution to the osmotic pressure of the solution.
An acceptable approximation for the osmolality ξm of a given aqueous solution is given by :
number of ions already present or formed by solvolysis from 1 molecule of solute.
m (^) = molality of the solution, that is the number of moles
of solute per kilogram of solvent ; = molal osmotic coefficient which takes account of the interactions between ions of opposite charge in the solution. It is dependent on the value of m. As the complexity of solutions increases, becomes difficult to measure.
The unit of osmolality is osmole per kilogram (osmol/kg), but the submultiple milliosmole per kilogram (mosmol/kg) is usually used.
Unless otherwise prescribed, osmolality is determined by measurement of the depression of freezing point. The following relationship exists between the osmolality and the depression of freezing point ∆ T :
Apparatus. The apparatus (osmometer) consists of :
— a means of cooling the container used for the measurement ;
— a system for measuring temperature consisting of a resistor sensitive to temperature (thermistor), with an appropriate current or potential-difference measurement device that may be graduated in temperature depression or directly in osmolality ; — a means of mixing the sample is usually included. Method. Prepare reference solutions as described in Table 2.2.35.-1, as required. Determine the zero of the apparatus using water R. Calibrate the apparatus using the reference solutions : introduce a suitable volume of sample into the measurement cell, as indicated by the equipment supplier, and start the cooling system. Usually, the mixing device is programmed to operate at a temperature below that expected through cryoscopic depression to prevent supercooling. A suitable device indicates attainment of equilibrium. Before each measurement, rinse the measurement cell with the solution to be examined. Table 2.2.35.-1. – Reference solutions for osmometer calibration Mass in grams of sodium chloride R per kilogram of water R
Real osmolality (mosmol/kg)
Ideal osmolality (mosmol/kg)
Molal osmotic coefficient
Cryoscopic depression (°C)
3.087 100 105.67 0.9463 0. 6.260 200 214.20 0.9337 0. 9.463 300 323.83 0.9264 0. 12.684 400 434.07 0.9215 0. 15.916 500 544.66 0.9180 0. 19.147 600 655.24 0.9157 1. 22.380 700 765.86 0.9140 1.
Carry out the same operations with the test sample. Read directly the osmolality or calculate it from the measured depression of freezing point. The test is not valid unless the value found is within 2 values of the calibration scale.
General Notices (1) apply to all monographs and other texts 3777
3778 See the information section on general monographs (cover pages)
3780 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 7.3 2.4.13. Sulfates
corrected 7.
All solutions used for this test must be prepared with distilled water R.
Add 3 mL of a 250 g/L solution of barium chloride R to 4.5 mL of sulfate standard solution (10 ppm SO 4 ) R1. Shake and allow to stand for 1 min. To 2.5 mL of this suspension, add 15 mL of the solution to be examined and 0.5 mL of acetic acid R. Prepare a standard in the same manner using 15 mL of sulfate standard solution (10 ppm SO 4 ) R instead of the solution to be examined.
After 5 min, any opalescence in the test solution is not more intense than that in the standard.
General Notices (1) apply to all monographs and other texts 3781