EUROPEAN PHARMACOPOEIA 11.
0 Zinc gluconate
pH (2.2.3) : 4.6 to 5.5.
Dissolve 1.0 g in 9 mL of carbon dioxide-free water R, ignoring
any slight turbidity.
Oxychlorides. Dissolve 10.0 g in 10 mL of carbon dioxide-free
water R. The solution is not more opalescent than reference
suspension II (2.2.1). To 1.5 mL of the solution add 7.5 mL
of ethanol (96 per cent) R. The solution may become cloudy
within 10 min. Any cloudiness disappears on the addition of
0.2 mL of dilute hydrochloric acid R.
Sulfates (2.4.13) : maximum 200 ppm.
Dilute 5 mL of solution S to 15 mL with distilled water R.
Prepare the standard using a mixture of 5 mL of sulfate
standard solution (10 ppm SO4) R and 10 mL of distilled
water R.
Aluminium, calcium, iron, magnesium. To 8 mL of
solution S add 2 mL of concentrated ammonia R and shake.
The solution is clear (2.2.1) and colourless (2.2.2, Method II).
Add 1 mL of disodium hydrogen phosphate solution R. The
solution remains clear for at least 5 min. Add 0.2 mL of
sodium sulfide solution R. A white precipitate is formed and
the supernatant remains colourless.
Ammonium (2.4.1) : maximum 400 ppm.
Dilute 0.5 mL of solution S to 15 mL with water R.
ASSAY
Dissolve 0.250 g in 5 mL of dilute acetic acid R. Carry out the
complexometric titration of zinc (2.5.11).
1 mL of 0.1 M sodium edetate is equivalent to 13.63 mg
of ZnCl2.
STORAGE
In a non-metallic container.
01/2022:2164 and filter. To 5 mL of the filtrate add 2 mL of cupri-tartaric
ZINC GLUCONATE
Zinci gluconas
C12H22ZnO14,xH2O Mr 455.7 (anhydrous substance)
DEFINITION
Zinc D-gluconate.
Content : 98.0 per cent to 102.0 per cent (anhydrous substance).
It may be anhydrous or contain a variable quantity of water.
CHARACTERS
Appearance : white or almost white, hygroscopic, crystalline
powder.
Solubility : soluble in water, practically insoluble in anhydrous
ethanol and in methylene chloride.
IDENTIFICATION
A. Thin-layer chromatography (2.2.27).
Test solution. Dissolve 20 mg of the substance to be
examined in 1 mL of water R.
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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
plate R (2-10 μm)].
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 100-105 °C for 20 min, then allow to cool to
room temperature.
Detection : spray with a solution containing 25 g/L of
ammonium molybdate R and 10 g/L of cerium sulfate R
in dilute sulfuric acid R, and heat at 100-105 °C for about
10 min.
Results : the principal spot in the chromatogram obtained
with the test solution is similar in position, colour and size
to the principal spot in the chromatogram obtained with
the reference solution.
B. Dissolve 0.1 g in 5 mL of water R. Add 0.5 mL of potassium
ferrocyanide solution R. A white precipitate is formed that
does not dissolve upon the addition of 5 mL of hydrochloric
acid R.
TESTS
Solution S. Dissolve 0.50 g in water R and dilute to 25 mL
with the same solvent.
Appearance of solution. Solution S is not more opalescent
than reference suspension II (2.2.1) and not more intensely
coloured than reference solution Y6 (2.2.2, Method II).
Sucrose and reducing sugars. Dissolve 0.5 g in a mixture of
2 mL of hydrochloric acid R1 and 10 mL of water R. Boil for
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 R and boil for 1 min. Allow to stand for 2 min. No
red precipitate is formed.
Chlorides (2.4.4) : maximum 500 ppm.
Dilute 5 mL of solution S to 15 mL with water R.
Sulfates (2.4.13): maximum 500 ppm.
Dissolve 2.0 g in a mixture of 10 mL of acetic acid R and 90 mL
of distilled water R.
Elemental impurities. Any method that fulfils the
requirements of general chapter 2.4.20. Determination of
elemental impurities may be used.
Element Maximum content (ppm)
Cadmium 1
Lead 2
Thallium 2
Water (2.5.32): maximum 12.0 per cent, determined on
80.0 mg.
ASSAY
Dissolve 0.400 g in 5 mL of dilute acetic acid R. Carry out the
complexometric titration of zinc (2.5.11).
1 mL of 0.1 M sodium edetate is equivalent to 45.57 mg
of C12H22ZnO14.
STORAGE
In a non-metallic, airtight container.
4425
Zinc oxide EUROPEAN PHARMACOPOEIA 11.0

01/2022:0252 07/2021:0306

ZINC OXIDE ZINC STEARATE

Zinci oxidum Zinci stearas

ZnO Mr 81.4 [557-05-1]

[1314-13-2]
DEFINITION
DEFINITION Zinc stearate [(C17H35COO)2Zn ; Mr 632] may contain varying
Content : 99.0 per cent to 100.5 per cent (ignited substance). proportions of zinc palmitate [(C15H31COO)2Zn ; Mr 576.2]
and zinc oleate [(C17H33COO)2Zn ; Mr 628].
CHARACTERS Content : 10.0 per cent to 12.0 per cent of Zn.
Appearance : soft, white or faintly yellowish-white, amorphous
CHARACTERS
powder, free from gritty particles.
Appearance : light, white or almost white, amorphous powder,
Solubility : practically insoluble in water and in ethanol (96 per free from gritty particles.
cent). It dissolves in dilute mineral acids.
Solubility : practically insoluble in water and in anhydrous
IDENTIFICATION ethanol.

A. It becomes yellow when strongly heated ; the yellow colour IDENTIFICATION

disappears on cooling.
A. Freezing point (2.2.18) : minimum 53 °C, determined on
B. Dissolve 0.1 g in 1.5 mL of dilute hydrochloric acid R and the residue obtained in the preparation of solution S (see
dilute to 5 mL with water R. The solution gives the reaction Tests).
of zinc (2.3.1).
B. Neutralise 5 mL of solution S to red litmus paper R with
strong sodium hydroxide solution R. The solution gives the
TESTS reaction of zinc (2.3.1).
Alkalinity. Shake 1.0 g with 10 mL of boiling water R. Add
0.1 mL of phenolphthalein solution R and filter. If the filtrate TESTS
is red, not more than 0.3 mL of 0.1 M hydrochloric acid is
required to change the colour of the indicator. Solution S. To 5.0 g add 50 mL of ether R and 40 mL of a
7.5 per cent V/V solution of nitric acid R in distilled water R.
Carbonates and substances insoluble in acids. Dissolve Heat under a reflux condenser until dissolution is complete.
1.0 g in 15 mL of dilute hydrochloric acid R. It dissolves Allow to cool. In a separating funnel, separate the aqueous
without effervescence and the solution is not more opalescent layer and shake the ether layer with 2 quantities, each of
than reference suspension II (2.2.1) and is colourless (2.2.2, 4 mL, of distilled water R. Combine the aqueous layers, wash
Method II). with 15 mL of ether R and heat on a water-bath until ether is
Elemental impurities. Any method that fulfils the completely eliminated. Allow to cool and dilute to 50.0 mL
requirements of general chapter 2.4.20. Determination of with distilled water R (solution S). Evaporate the ether layer to
elemental impurities may be used. dryness and dry the residue at 105 °C.
Appearance of solution. Solution S is not more intensely
Element Maximum content (ppm)
coloured than reference solution Y6 (2.2.2, Method II).
Cadmium 5
Appearance of solution of fatty acids. Dissolve 0.5 g of
Lead 10 the residue obtained in the preparation of solution S in
10 mL of chloroform R. The solution is clear (2.2.1) and not
Thallium 5 more intensely coloured than reference solution Y5 (2.2.2,
Method II).
Acidity or alkalinity. Shake 1.0 g with 5 mL of ethanol (96 per
Iron (2.4.9) : maximum 200 ppm. cent) R and add 20 mL of carbon dioxide-free water R and
Dissolve 50 mg in 1 mL of dilute hydrochloric acid R and 0.1 mL of phenol red solution R. Not more than 0.3 mL of
dilute to 10 mL with water R. Use 0.5 mL of thioglycollic acid R 0.1 M hydrochloric acid or 0.1 mL of 0.1 M sodium hydroxide
in this test. is required to change the colour of the indicator.
Acid value of the fatty acids (2.5.1) : 195 to 210.
Loss on ignition : maximum 1.0 per cent, determined on Dissolve 0.20 g of the residue obtained in the preparation of
1.00 g by ignition to constant mass at 500 ± 50 °C. solution S in 25 mL of the prescribed mixture of solvents.
Chlorides (2.4.4) : maximum 250 ppm.
ASSAY Dilute 2 mL of solution S to 15 mL with water R.
Dissolve 0.150 g in 10 mL of dilute acetic acid R. Carry out the Sulfates (2.4.13) : maximum 0.6 per cent.
complexometric titration of zinc (2.5.11).
Dilute 1 mL of solution S to 50 mL with distilled water R.
1 mL of 0.1 M sodium edetate is equivalent to 8.14 mg of ZnO. Dilute 12.5 mL of this solution to 15 mL with distilled water R.

4426 See the information section on general monographs (cover pages)

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