7/23/2021 Chitosan Hydrochloride
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BP2019 (9.7)
Monographs: Medicinal and Pharmaceutical Substances
Chitosan Hydrochloride
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You are viewing the BP 2019 (incorporating Ph.Eur. Supplement 9.7, effective 01/04/2019)
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Chitosan Hydrochloride
General Notices
(Ph. Eur. monograph 1774)
Ph Eur
DEFINITION
Chitosan hydrochloride is the chloride salt of an unbranched binary heteropolysaccharide consisting of the
two units N-acetyl-d-glucosamine and d-glucosamine, obtained by partial deacetylation of chitin normally
leading to a degree of deacetylation of 70.0 per cent to 95.0 per cent. Chitin is extracted from the shells of
shrimp and crab.
PRODUCTION
The animals from which chitosan hydrochloride is derived must fulfil the requirements for the health of
animals suitable for human consumption to the satisfaction of the competent authority. It must have been
shown to what extent the method of production allows inactivation or removal of any contamination by
viruses or other infectious agents.
CHARACTERS
Appearance
White or almost white, fine powder.
Solubility
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Sparingly soluble in water, practically insoluble in anhydrous ethanol.
IDENTIFICATION
A. Infrared absorption spectrophotometry (2.2.24).
Preparation Discs.
Comparison chitosan hydrochloride CRS.
B. It gives reaction (a) of chlorides (2.3.1).
C. Dilute 50 mL of solution S (see Tests) to 250 mL with a 25 per cent V/V solution of ammonia R. A
voluminous gelatinous mass is formed.
D. To 10 mL of solution S add 90 mL of acetone R. A voluminous gelatinous mass is formed.
TESTS
Solution S
Dissolve 1.0 g in 100 mL of water R and stir vigorously for 20 min with a mechanical stirrer.
Appearance of solution
Solution S is not more opalescent than reference suspension II (2.2.1) and not more intensely coloured than
reference solution BY5 (2.2.2, Method II).
Matter insoluble in water
Maximum 0.5 per cent.
Add 2.00 g to 400.0 mL of water R while stirring until no further dissolution takes place. Transfer the
solution to a 2 L beaker, and add 200 mL of water R. Boil the solution gently for 2 h, covering the beaker
during the operation. Filter through a sintered-glass filter (40) (2.1.2), wash the residue with water and dry to
constant weight in an oven at 100-105 °C. The residue weighs a maximum of 10 mg.
pH (2.2.3)
4.0 to 6.0 for solution S.
Viscosity (2.2.10)
80 per cent to 120 per cent of the value stated on the label, determined on solution S.
Determine the viscosity using a rotating viscometer at 20 °C with a spindle rotating at 20 r/min, using a
suitable spindle for the range of the expected viscosity.
Degree of deacetylation
Test solution Dissolve 0.250 g in water R and dilute to 50.0 mL with the same solvent, stirring vigorously.
Dilute 1.0 mL of this solution to 100.0 mL with water R. Measure the absorbance (2.2.25) from 200 nm to
205 nm as the first derivative of the absorbance curve. Determine the pH of the solution.
Reference solutions Prepare solutions of 1.0 µg/mL, 5.0 µg/mL, 15.0 µg/mL and 35.0 µg/mL of N-
acetylglucosamine R in water R. Measure the absorbance (2.2.25) from 200 nm to 205 nm of each solution as
the first derivative of the absorption curve. Make a standard curve by plotting the first derivative at 202 nm
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as a function of the concentration of N-acetylglucosamine, and calculate the slope of the curve by least
squares linear regression. Use the standard curve to determine the equivalent amount of N-acetylglucosamine
for the substance to be examined.
Calculate the degree of deacetylation (molar) using the following expression:
100×M1×(C1-C2)(M1×C1)-[(M1-M3)×C2]
C1 = concentration of chitosan hydrochloride in the test solution in micrograms per millilitre;
C2 concentration of N-acetylglucosamine in the test solution, as determined from the standard
=
curve prepared using the reference solution in micrograms per millilitre;
M1 = 203 (relative molecular mass of N-acetylglucosamine unit (C8H13NO5) in polymer);
M3 = relative molecular mass of chitosan hydrochloride.
M3 is calculated from the pH in solution, assuming a pKa value of 6.8, using the following equations:
M3=f×M2+(1-f)×(M2+36.5)
f=p1+p
p=10(pH-pKa)
161 (relative molecular mass of deacetylated unit (glucosamine) (C6H11NO4) in
M2 =
polymer).
Chlorides
10.0 per cent to 20.0 per cent.
Introduce 0.200 g into a 250 mL borosilicate flask fitted with a reflux condenser. Add 40 mL of a mixture of
1 volume of nitric acid R and 2 volumes of water R. Boil gently under a reflux condenser for 5 min. Cool
and add 25 mL of water R through the condenser. Add 16.0 mL of 0.1 M silver nitrate, shake vigorously and
titrate with 0.1 M ammonium thiocyanate, using 1 mL of ferric ammonium sulfate solution R2 as indicator,
and shaking vigorously towards the end-point. Carry out a blank titration.
1 mL of 0.1 M silver nitrate is equivalent to 3.55 mg of Cl.
Loss on drying (2.2.32)
Maximum 10 per cent, determined on 1.000 g by drying in an oven at 105 °C.
Sulfated ash (2.4.14)
Maximum 1.0 per cent, determined on 1.0 g.
STORAGE
At a temperature of 2 °C to 8 °C, protected from moisture and light.
LABELLING
The label states the nominal viscosity in millipascal seconds for a 10 g/L solution in water R.
Ph Eur
Medicines & Healthcare products Regulatory Agency
© Crown Copyright 2018
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