Magnesium glycerophosphate EUROPEAN PHARMACOPOEIA 11.

Test solution. Dissolve 20 mg of the substance to be 01/2017:1446

examined in 1 mL of water R.
Reference solution. Dissolve 20 mg of calcium gluconate CRS
in 1 mL of water R, heating if necessary in a water-bath at
60 °C.
Plate : TLC silica gel plate R (5-40 μm) [or TLC silica gel MAGNESIUM GLYCEROPHOSPHATE
plate R (2-10 μm)].
Magnesii glycerophosphas
Mobile phase : concentrated ammonia R, ethyl acetate R,
water R, ethanol (96 per cent) R (10:10:30:50 V/V/V/V).
Application : 1 μL.
Development : over 3/4 of the plate.
Drying : at 105 °C for 20 min, then allow to cool to room C3H7MgO6P Mr 194.4
temperature.
DEFINITION
Detection : spray with a solution containing 25 g/L of
ammonium molybdate R and 10 g/L of cerium sulfate R in Mixture, in variable proportions, of magnesium salts of
dilute sulfuric acid R, then heat at 105 °C for about 10 min. (RS)-2,3-dihydroxypropyl phosphate and 2-hydroxy-1-
(hydroxymethyl)ethyl phosphate, which may be hydrated.
Results : the principal spot in the chromatogram obtained Content : 11.0 per cent to 12.5 per cent of Mg (dried substance).
with the test solution is similar in position, colour and size
to the principal spot in the chromatogram obtained with CHARACTERS
the reference solution. Appearance : white or almost white powder, hygroscopic.
B. To 10 mL of solution S (see Tests) add 3 mL of ammonium Solubility : practically insoluble in ethanol (96 per cent). It
chloride solution R. A slight opalescence may be observed. dissolves in dilute solutions of acids.
Add 10 mL of disodium hydrogen phosphate solution R. A
white precipitate is formed that does not dissolve upon the IDENTIFICATION
addition of 2 mL of dilute ammonia R1. A. Mix 1 g with 1 g of potassium hydrogen sulfate R in
a test tube fitted with a glass tube. Heat strongly and
direct the white vapour towards a piece of filter paper
TESTS impregnated with a freshly prepared 10 g/L solution of
Solution S. Dissolve 1.0 g in water R and dilute to 50 mL with sodium nitroprusside R. The filter paper develops a blue
the same solvent. colour in contact with piperidine R.
Appearance of solution. Solution S is clear (2.2.1) and not B. Ignite 0.1 g in a crucible. Take up the residue with 5 mL of
more intensely coloured than reference solution Y7 (2.2.2, nitric acid R and heat on a water-bath for 1 min. Filter. The
Method II). filtrate gives reaction (b) of phosphates (2.3.1).
Sucrose and reducing sugars. Dissolve 0.5 g in a mixture of C. It gives the reaction of magnesium (2.3.1).
2 mL of hydrochloric acid R1 and 10 mL of water R. Boil for TESTS
5 min, allow to cool, add 10 mL of sodium carbonate solution R
and allow to stand for 10 min. Dilute to 25 mL with water R Solution S. Dissolve 2.5 g in carbon dioxide-free water R
and filter. To 5 mL of the filtrate add 2 mL of cupri-tartaric prepared from distilled water R and dilute to 50 mL with the
solution R and boil for 1 min. Allow to stand for 2 min. No same solvent.
red precipitate is formed. Appearance of solution. Solution S is not more opalescent
Chlorides (2.4.4): maximum 500 ppm. than reference suspension III (2.2.1).
Acidity. Dissolve 1.0 g in 100 mL of carbon dioxide-free
Dilute 5 mL of solution S to 15 mL with water R. water R. Add 0.1 mL of phenolphthalein solution R. Not more
Sulfates (2.4.13) : maximum 500 ppm. than 1.5 mL of 0.1 M sodium hydroxide is required to change
the colour of the indicator.
Dissolve 2.0 g in a mixture of 10 mL of acetic acid R and 90 mL
of distilled water R. Glycerol and ethanol (96 per cent)-soluble substances :
maximum 1.5 per cent.
Water (2.5.32) : maximum 12.0 per cent, determined on Shake 1.0 g with 25 mL of ethanol (96 per cent) R for 2 min.
80 mg. Filter and wash the residue with 5 mL of ethanol (96 per
Microbial contamination cent) R. Combine the filtrate and the washings, evaporate to
3
dryness on a water-bath and dry the residue at 70 °C for 1 h.
TAMC : acceptance criterion 10 CFU/g (2.6.12). The residue weighs a maximum of 15 mg.
TYMC : acceptance criterion 102 CFU/g (2.6.12). Chlorides (2.4.4): maximum 0.15 per cent.
Dissolve 1.0 g in water R and dilute to 100 mL with the same
ASSAY solvent. Dilute 3.5 mL of this solution to 15 mL with water R.
Phosphates (2.4.11) : maximum 0.5 per cent.
Dissolve 0.350 g in 100 mL of water R and carry out the
complexometric titration of magnesium (2.5.11). Dilute 4 mL of solution S to 100 mL with water R. Dilute 1 mL
of this solution to 100 mL with water R.
1 mL of 0.1 M sodium edetate is equivalent to 41.46 mg Sulfates (2.4.13) : maximum 0.1 per cent.
of C12H22MgO14.
Dilute 3 mL of solution S to 15 mL with distilled water R.
Iron (2.4.9) : maximum 150 ppm.
STORAGE
Dissolve 67 mg in water R and dilute to 10 mL with the same
In an airtight container. solvent.

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EUROPEAN PHARMACOPOEIA 11.0 Magnesium lactate dihydrate

Loss on drying (2.2.32) : maximum 12.0 per cent, determined Loss on ignition : 29.0 per cent to 32.5 per cent.
on 1.000 g by drying in an oven at 150 °C for 4 h. Heat 0.5 g gradually to 900 ± 50 °C and ignite to constant
ASSAY mass.
Dissolve 0.200 g in 40 mL of water R. Carry out the ASSAY
complexometric titration of magnesium (2.5.11).
Dissolve 0.100 g in a mixture of 2 mL of dilute hydrochloric
1 mL of 0.1 M sodium edetate is equivalent to 2.431 mg of Mg. acid R and 20 mL of water R. Carry out the complexometric
STORAGE titration of magnesium (2.5.11).
In an airtight container. 1 mL of 0.1 M sodium edetate is equivalent to 5.832 mg of
Mg(OH)2.

01/2021:0039
01/2017:2160

MAGNESIUM HYDROXIDE
Magnesii hydroxidum MAGNESIUM LACTATE DIHYDRATE
Mg(OH)2 Mr 58.32 Magnesii lactas dihydricus
[1309-42-8]
DEFINITION
Content : 95.0 per cent to 100.5 per cent of Mg(OH)2.
CHARACTERS C6H10MgO6,2H2O Mr 238.5
Appearance : white or almost white, fine, amorphous powder. DEFINITION
Solubility : practically insoluble in water. It dissolves in dilute
Magnesium bis(2-hydroxypropanoate) or mixture of
acids.
magnesium (2R)-, (2S)- and (2RS)-2-hydroxypropanoate
IDENTIFICATION dihydrate.
A. Dissolve about 15 mg in 2 mL of dilute nitric acid R and Content : 98.0 per cent to 102.0 per cent (dried substance).
neutralise with dilute sodium hydroxide solution R. The
solution gives the reaction of magnesium (2.3.1). CHARACTERS
B. Loss on ignition (see Tests). Appearance : white or almost white, crystalline or granular
powder.
TESTS Solubility : slightly soluble in water, soluble in boiling water,
Solution S. Dissolve 5.0 g in a mixture of 50 mL of acetic practically insoluble in ethanol (96 per cent).
acid R and 50 mL of distilled water R. Not more than slight
effervescence is produced. Boil for 2 min, cool and dilute to IDENTIFICATION
100 mL with dilute acetic acid R. Filter, if necessary, through a A. It gives the reaction of lactates (2.3.1).
previously ignited and tared porcelain or silica filter crucible B. It gives the reaction of magnesium (2.3.1).
of suitable porosity to give a clear filtrate. Keep the residue for
the test for substances insoluble in acetic acid. TESTS
Appearance of solution. Solution S is not more intensely Solution S. Dissolve 5.0 g with heating in carbon dioxide-free
coloured than reference solution B3 (2.2.2, Method II). water R prepared from distilled water R, allow to cool and
Soluble substances : maximum 2.0 per cent. dilute to 100 mL with the same solvent.
Mix 2.00 g with 100 mL of water R and boil for 5 min. Filter Appearance of solution. Solution S is not more opalescent
whilst hot through a sintered-glass filter (40) (2.1.2), allow than reference suspension II (2.2.1) and not more intensely
to cool and dilute to 100 mL with water R. Evaporate 50 mL coloured than reference solution BY6 (2.2.2, Method II).
of the filtrate to dryness and dry at 100-105 °C. The residue pH (2.2.3): 6.5 to 8.5 for solution S.
weighs a maximum of 20 mg.
Chlorides (2.4.4) : maximum 200 ppm.
Substances insoluble in acetic acid : maximum 0.1 per cent.
Dilute 5 mL of solution S to 15 mL with water R.
Any residue obtained during the preparation of solution S,
washed, dried, and ignited at 600 ± 50 °C, weighs not more Sulfates (2.4.13): maximum 400 ppm.
than 5 mg. Dilute 7.5 mL of solution S to 15 mL with distilled water R.
Chlorides (2.4.4): maximum 0.1 per cent. Iron (2.4.9) : maximum 50 ppm.
Dilute 1 mL of solution S to 15 mL with water R. Dilute 4 mL of solution S to 10 mL with water R.
Sulfates (2.4.13) : maximum 1.0 per cent. Loss on drying (2.2.32) : 14.0 per cent to 17.0 per cent,
Dilute 0.3 mL of solution S to 15 mL with distilled water R. determined on 0.500 g by drying in an oven at 125 °C.
Calcium (2.4.3) : maximum 1.5 per cent. ASSAY
Dilute 1.3 mL of solution S to 150 mL with distilled water R. Dissolve 0.180 g in water R and dilute to 300 mL with the
Iron (2.4.9) : maximum 0.07 per cent. same solvent. Carry out the complexometric titration of
Dissolve 0.15 g in 5 mL of dilute hydrochloric acid R and dilute magnesium (2.5.11).
to 10 mL with water R. Dilute 1 mL of the solution to 10 mL 1 mL of 0.1 M sodium edetate is equivalent to 20.25 mg
with water R. of C6H10MgO6.

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