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Glucose, Liquid

The document outlines the specifications and testing methods for liquid glucose and spray-dried glucose as per the European Pharmacopoeia 11.0. It includes details on preparation, identification tests, and quality parameters such as dextrose equivalent and permissible limits for impurities. The liquid glucose must contain at least 70% dry matter and a minimum dextrose equivalent of 20, while the spray-dried form is described as a white, hygroscopic powder or granules.

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0% found this document useful (0 votes)
9 views1 page

Glucose, Liquid

The document outlines the specifications and testing methods for liquid glucose and spray-dried glucose as per the European Pharmacopoeia 11.0. It includes details on preparation, identification tests, and quality parameters such as dextrose equivalent and permissible limits for impurities. The liquid glucose must contain at least 70% dry matter and a minimum dextrose equivalent of 20, while the spray-dried form is described as a white, hygroscopic powder or granules.

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qa24suresh
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Glucose, liquid EUROPEAN PHARMACOPOEIA 11.

Pipette 25.0 mL of cupri-tartaric solution R into a 250 mL flask


and add 18.5 mL of the test solution from the burette, mix and
add a few glass beads. Place the flask on a hot plate, previously
adjusted so that the solution begins to boil after 2 min ± 15 s.
Allow to boil for exactly 120 s, add 1 mL of a 1 g/L solution of
D. D-arabino-hex-2-ulopyranose (fructose). methylene blue R and titrate with the test solution (V1) until
the blue colour disappears. Maintain the solution at boiling
throughout the titration.
01/2017:1330 Standardise the cupri-tartaric solution using a 6.00 g/L
solution of glucose R (V0).
Calculate the dextrose equivalent using the following
expression :
300 ´ V0 ´ 100
GLUCOSE, LIQUID
V1 ´ M ´ D
Glucosum liquidum V0 = total volume of glucose standard solution, in
millilitres,
DEFINITION
V1 = total volume of test solution, in millilitres,
Aqueous solution containing a mixture of glucose,
oligosaccharides and polysaccharides obtained by hydrolysis M = mass of the sample, in grams,
of starch. D = percentage content of dry matter in the substance.
It contains a minimum of 70.0 per cent dry matter.
The degree of hydrolysis, expressed as dextrose LABELLING
equivalent (DE), is not less than 20 (nominal value). The label states the dextrose equivalent (DE) (= nominal
CHARACTERS value).
Appearance : clear, colourless or brown, viscous liquid.
Solubility : miscible with water. 01/2017:1525
It may partly or totally solidify at room temperature and
liquefies again when heated to 50 °C.
IDENTIFICATION
A. Dissolve 0.1 g in 2.5 mL of water R and heat with 2.5 mL of GLUCOSE, LIQUID, SPRAY-DRIED
cupri-tartaric solution R. A red precipitate is formed.
B. Dip, for 1 s, a suitable stick with a reactive pad containing
glucose-oxidase, peroxidase and a hydrogen-donating
Glucosum liquidum dispersione desiccatum
substance, such as tetramethylbenzidine, in a 5 g/L solution DEFINITION
of the substance to be examined. Observe the colour of the Mixture of glucose, oligosaccharides and polysaccharides,
reactive pad ; within 60 s the colour changes from yellow obtained by the partial hydrolysis of starch.
to green or blue.
The degree of hydrolysis, expressed as dextrose
C. It is a clear, colourless or brown, viscous liquid, miscible equivalent (DE), is not less than 20 (nominal value).
with water. The substance may partly or totally solidify at
room temperature and liquefies again when heated to 50 °C. CHARACTERS
D. Dextrose equivalent (see Tests). Appearance : white or almost white, slightly hygroscopic
powder or granules.
TESTS
Solubility : freely soluble in water.
Solution S. Dissolve 25.0 g in carbon dioxide-free water R and
dilute to 50.0 mL with the same solvent. IDENTIFICATION
pH (2.2.3) : 4.0 to 6.0. A. Dissolve 0.1 g in 2.5 mL of water R and heat with 2.5 mL of
Mix 1 mL of a 223.6 g/L solution of potassium chloride R and cupri-tartaric solution R. A red precipitate is formed.
30 mL of solution S. B. Dip, for 1 s, a suitable stick with a reactive pad containing
glucose-oxidase, peroxidase and a hydrogen-donating
Sulfur dioxide (2.5.29) : maximum 20 ppm ; maximum
substance, such as tetramethylbenzidine, in a 5 g/L solution
400 ppm if intended for the production of lozenges or pastilles
of the substance to be examined. Observe the colour of the
obtained by high boiling techniques, provided that the final
reactive pad ; within 60 s the colour changes from yellow
product contains maximum 50 ppm of sulfur dioxide.
to green or blue.
Loss on drying (2.2.32) : maximum 30.0 per cent, determined C. It is a powder or granules.
on 1.000 g. Triturate the sample with 3.000 g of kieselguhr G R,
previously dried at 80 °C under high vacuum for 2 h, and dry D. Dextrose equivalent (see Tests).
at 80 °C under high vacuum for 2 h. TESTS
Sulfated ash (2.4.14) : maximum 0.5 per cent, determined on Solution S. Dissolve 12.5 g in carbon dioxide-free water R and
1.0 g. dilute to 50.0 mL with the same solvent.
Dextrose equivalent (DE): within 10 per cent of the nominal pH (2.2.3) : 4.0 to 7.0.
value.
Mix 1 mL of a 223.6 g/L solution of potassium chloride R and
Weigh an amount of the substance to be examined equivalent 30 mL of solution S.
to 2.85-3.15 g of reducing carbohydrates, calculated as
dextrose equivalent, into a 500 mL volumetric flask. Dissolve Sulfur dioxide (2.5.29) : maximum 20 ppm.
in water R and dilute to 500.0 mL with the same solvent. Loss on drying (2.2.32) : maximum 6.0 per cent, determined
Transfer the solution to a 50 mL burette. on 10.00 g by drying in an oven at 105 °C.

2898 See the information section on general monographs (cover pages)


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