EUROPEAN PHARMACOPOEIA 11.

0 Sodium starch glycolate (type C)

cent) R and filter. Collect the residue and place it in an oven at cool, add a few drops of ammonium carbonate solution R,
105 °C for 4 h. Place the dried residue in a mortar and crush. evaporate to dryness and incinerate cautiously. Allow to cool
Determine the sulfated ash content (C) (2.4.14) on 1.000 g of and dissolve the residue in 50 mL of water R.
the powder obtained. Appearance of gel. The gel obtained in identification test B is
Calculate the degree of sodium carboxymethyl substitution (S) colourless (2.2.2, Method II).
using the following expression :
pH (2.2.3) : 5.5 to 7.5 for the gel obtained in identification
( 162 + 58A)C test B.
S=
( 7102 - 80C ) Sodium glycolate : maximum 2.0 per cent. Carry out the test
protected from light.
The degree of substitution is the sum of A and S.
Test solution. Place 0.20 g in a beaker. Add 5 mL of acetic
Particle-size distribution (2.9.31 or 2.9.38).◊ acid R and 5 mL of water R. Stir until dissolution is complete
(about 10 min). Add 50 mL of acetone R and 1 g of sodium
chloride R. Filter through a fast filter paper impregnated
with acetone R, rinse the beaker and filter with acetone R.
01/2020:1566
Combine the filtrate and washings and dilute to 100.0 mL
with acetone R. Allow to stand for 24 h without shaking. Use
the clear supernatant.
Reference solution. Dissolve 0.310 g of glycolic acid R,
previously dried in a desiccator (2.2.32), in water R and dilute
SODIUM STARCH GLYCOLATE to 500.0 mL with the same solvent. To 5.0 mL of this solution,
(TYPE C)(7) add 5 mL of acetic acid R and allow to stand for about 30 min.
Add 50 mL of acetone R and 1 g of sodium chloride R and
dilute to 100.0 mL with acetone R.
Carboxymethylamylum natricum C Heat 2.0 mL of the test solution on a water-bath for
DEFINITION 20 min. Cool to room temperature and add 20.0 mL of
2,7-dihydroxynaphthalene solution R. Shake and heat on a
Sodium salt of a partly O-carboxymethylated starch, water-bath for 20 min. Cool under running water, transfer to
cross-linked by physical dehydration. a volumetric flask and dilute to 25.0 mL with sulfuric acid R,
Content : 2.8 per cent to 5.0 per cent of Na (Ar 22.99) maintaining the flask under running water. Within 10 min,
(substance washed with ethanol (80 per cent V/V) and dried). measure the absorbance (2.2.25) at 540 nm using water R as
the compensation liquid. The absorbance of the solution
CHARACTERS prepared with the test solution is not greater than that of a
Appearance : white or almost white, fine, free-flowing powder, solution prepared at the same time and in the same manner
very hygroscopic. with 2.0 mL of the reference solution.
Microscopic examination : it is seen to consist of granules, Sodium chloride : maximum 1 per cent.
irregularly shaped, ovoid or pear-shaped, 30-100 μm in size,
Shake 1.00 g with 20 mL of ethanol (80 per cent V/V) R for
or rounded, 10-35 μm in size ; compound granules consisting
10 min and filter. Repeat the operation 4 times. Dry the
of 2-4 components occur occasionally ; the granules have
residue to constant mass at 100 °C and set aside for the assay.
an eccentric hilum and clearly visible concentric striations ;
Combine the filtrates. Evaporate to dryness, take up the
between crossed nicol prisms, the granules show a distinct
residue with water R and dilute to 25.0 mL with the same
black cross intersecting at the hilum ; small crystals are visible
solvent. To 10.0 mL of the solution add 30 mL of water R and
at the surface of the granules. The granules show considerable
5 mL of dilute nitric acid R. Titrate with 0.1 M silver nitrate,
swelling in contact with water.
determining the end-point potentiometrically (2.2.20), using
Solubility : soluble in water, practically insoluble in methylene a silver-based indicator electrode and a double-junction
chloride. It gives a translucent gel-like product in water. reference electrode containing a 100 g/L solution of potassium
nitrate R in the outer jacket and a standard filling solution in
IDENTIFICATION the inner jacket.
A. pH (see Tests).
1 mL of 0.1 M silver nitrate is equivalent to 5.844 mg of NaCl.
B. Prepare with shaking and without heating a mixture of
4.0 g of the substance to be examined and 20 mL of carbon Iron (2.4.9) : maximum 20 ppm, determined on solution S.
dioxide-free water R. The mixture has the appearance of a Loss on drying (2.2.32) : maximum 7.0 per cent, determined
gel. Add 100 mL of carbon dioxide-free water R and shake : on 1.000 g by drying in an oven at 105 °C for 4 h.
the gel remains stable (difference from types A and B). Microbial contamination. It complies with the test for
Keep the gel for the tests for appearance of gel and pH. Escherichia coli and Salmonella (2.6.13).
C. To 5 mL of the gel obtained in identification test B add
0.05 mL of iodine solution R1. A dark blue colour is ASSAY
produced.
To 0.500 g of the dried and crushed residue obtained in the
D. Solution S (see Tests) gives reaction (a) of sodium (2.3.1). test for sodium chloride add 80 mL of anhydrous acetic acid R
and heat under a reflux condenser for 2 h. Cool the solution
TESTS
to room temperature. Titrate with 0.1 M perchloric acid,
Solution S. Place 2.5 g in a silica or platinum crucible and determining the end-point potentiometrically (2.2.20). Carry
add 2 mL of a 500 g/L solution of sulfuric acid R. Heat on a out a blank test.
water-bath, then cautiously over a naked flame, raising the
1 mL of 0.1 M perchloric acid is equivalent to 2.299 mg of Na.
temperature progressively, and then incinerate in a muffle
furnace at 600 ± 25 °C. Continue heating until all black
particles have disappeared. Allow to cool, add a few drops STORAGE
of sulfuric acid R, heat and incinerate as above. Allow to In an airtight container, protected from light.
(7) In contrast to sodium starch glycolate type A and type B, this monograph has NOT undergone pharmacopoeial harmonisation.

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