(Ph. Eur. monograph 2238)
56087-11-7
Action and use
Fluid absorber; treatment of burns, wounds and skin ulcers; preparation for skin grafting.
DEFINITION
Three-dimensional network made of dextran chains O,O′-cross-linked with 2-hydroxypropane-1,3-diyl bridges and O- substituted with 2,3-dihydroxypropyl and 2-hydroxy-1-(hydroxymethyl)ethyl groups.
CHARACTERS
Appearance
White or almost white, spherical beads.
Solubility
Practically insoluble in water. It swells in water and in electrolyte solutions.
PRODUCTION
The absorption capacity is determined using a 9.0 g/L solution of sodium chloride R containing 20 μL/L of polysorbate 20 R or another suitable solution, with a suitable, validated method.
The particle size is controlled to a minimum of 80 per cent of the number of dry beads within 100-300 μm and a maximum of 7 per cent of their number below 100 μm using a suitable, validated method.
IDENTIFICATION
A. The substance to be examined is practically insoluble in water R. It swells in water R.
B. Infrared absorption spectrophotometry (2.2.24).
Preparation: Grind the substance to be examined in acetone R. Evaporate the solvent at room temperature and use the residue.
Comparison: dextranomer CRS.
TESTS
pH (2.2.3)
5.3 to 7.5.
Introduce 0.50 g to 30 mL of a freshly prepared 74.6 g/L solution of potassium chloride R. Allow to stand for 2 min.
Determine the pH on the mucilage obtained.
Boron
Maximum 30 ppm.
Inductively coupled plasma-atomic emission spectrometry (ICP-AES) (2.2.57).
Test solution: Introduce 3.0 g into a platinum dish and moisten with 5 mL of a 32.1 g/L solution of magnesium nitrate R in a mixture of equal volumes of ethanol (96 per cent) R and distilled water R. Evaporate to dryness on a water-bath. Ignite at 550 °C for 5 h. Take up the residue with 5 mL of 6 M hydrochloric acid R and transfer to a 50 mL volumetric flask. Add about 20 mL of distilled water R and allow to digest for 1 h on a water-bath. Allow to cool and dilute to 50.0 mL with distilled
water R.
Reference solutions: Prepare the reference solutions using a solution of boric acid R containing 10 ppm of boron. Proceed as described for the test solution.
Wavelength: 249.773 nm.
Loss on drying (2.2.32)
Maximum 10.0 per cent, determined on 1.000 g by drying in an oven at 105 °C for 15 h.
Sulfated ash (2.4.14)
Maximum 0.4 per cent, determined on 1.0 g.
Microbial contamination
TAMC: acceptance criterion 10 CFU/g (2.6.12), determined using the pour-plate method.
