12/11/24, 11:17 PM Aspirin - British Pharmacopoeia
Quality standards
Entries in this edition will be effective from 01 January 2025
Aspirin
General Notices
(Acetylsalicylic Acid, Ph. Eur. monograph 0309)
C 9H 8O 4 180.2 50-78-2
Action and use
Salicylate; non-selective cyclo-oxygenase inhibitor; antipyretic; analgesic; anti-inflammatory.
Preparations
Aspirin Tablets
Aspirin Dispersible Tablets
Aspirin Effervescent Soluble Tablets
Aspirin Gastro-resistant Tablets
Aspirin and Caffeine Tablets
Co-codaprin Tablets
Co-codaprin Dispersible Tablets
Ph Eur
DEFINITION
2-(Acetyloxy)benzoic acid.
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Content
99.5 per cent to 101.0 per cent (dried substance).
CHARACTERS
Appearance
White or almost white, crystalline powder or colourless crystals.
Solubility
Slightly soluble in water, freely soluble in ethanol (96 per cent).
mp
About 143 °C (instantaneous method).
IDENTIFICATION
First identification: A, B.
Second identification: B, C, D.
A. Infrared absorption spectrophotometry (2.2.24).
Comparison acetylsalicylic acid CRS.
B. To 0.2 g add 4 mL of dilute sodium hydroxide solution R and boil for 3 min. Cool and add
5 mL of dilute sulfuric acid R. A crystalline precipitate is formed. Filter, wash the precipitate and
dry at 100-105 °C. The melting point (2.2.14) is 156 °C to 161 °C.
C. In a test tube mix 0.1 g with 0.5 g of calcium hydroxide R. Heat the mixture and expose to
the fumes produced a piece of filter paper impregnated with 0.05 mL of nitrobenzaldehyde
solution R. A greenish-blue or greenish-yellow colour develops on the paper. Moisten the paper
with dilute hydrochloric acid R. The colour becomes blue.
D. Dissolve with heating about 20 mg of the precipitate obtained in identification test B in 10 mL
of water R and cool. The solution gives reaction (a) of salicylates (2.3.1).
TESTS
Appearance of solution
The solution is clear (2.2.1) and colourless (2.2.2, Method II).
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Dissolve 1.0 g in 9 mL of ethanol (96 per cent) R.
Related substances
Liquid chromatography (2.2.29). Prepare the solutions immediately before use.
Test solution Dissolve 0.100 g of the substance to be examined in acetonitrile for
chromatography R and dilute to 10.0 mL with the same solvent.
Reference solution (a) Dissolve 50.0 mg of salicylic acid R (impurity C) in the mobile phase and
dilute to 50.0 mL with the mobile phase. Dilute 1.0 mL of the solution to 100.0 mL with the mobile
phase.
Reference solution (b) Dissolve 10 mg of salicylic acid R (impurity C) in the mobile phase and
dilute to 10.0 mL with the mobile phase. To 1.0 mL of the solution add 0.2 mL of the test solution
and dilute to 100.0 mL with the mobile phase.
Reference solution (c) Dissolve with the aid of ultrasound the contents of a vial of acetylsalicylic
acid for peak identification CRS (containing impurities A, B, D, E and F) in 1.0 mL of
acetonitrile R.
Column:
— size: l = 0.25 m, Ø = 4.6 mm;
— stationary phase: octadecylsilyl silica gel for chromatography R (5 µm).
Mobile phase phosphoric acid R, acetonitrile for chromatography R, water R (2:400:600 V/V/V).
Flow rate 1 mL/min.
Detection Spectrophotometer at 237 nm.
Injection 10 µL.
Run time 7 times the retention time of acetylsalicylic acid.
Identification of impurities Use the chromatogram obtained with reference solution (a) to identify
the peak due to impurity C; use the chromatogram supplied with acetylsalicylic acid for peak
identification CRS and the chromatogram obtained with reference solution (c) to identify the
peaks due to impurities A, B, D, E and F.
Relative retention With reference to acetylsalicylic acid (retention time = about 5 min):
impurity A = about 0.7; impurity B = about 0.8; impurity C = about 1.3; impurity D = about 2.3;
impurity E = about 3.2; impurity F = about 6.0.
System suitability Reference solution (b):
— resolution: minimum 6.0 between the peaks due to acetylsalicylic acid and impurity C.
Limits:
— impurities A, B, C, D, E, F: for each impurity, not more than 1.5 times the area of the
principal peak in the chromatogram obtained with reference solution (a) (0.15 per cent);
— unspecified impurities: for each impurity, not more than 0.5 times the area of the principal
peak in the chromatogram obtained with reference solution (a) (0.05 per cent);
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— total: not more than 2.5 times the area of the principal peak in the chromatogram obtained
with reference solution (a) (0.25 per cent);
— disregard limit: 0.3 times the area of the principal peak in the chromatogram obtained with
reference solution (a) (0.03 per cent).
Loss on drying (2.2.32)
Maximum 0.5 per cent, determined on 1.000 g by drying in vacuo.
Sulfated ash (2.4.14)
Maximum 0.1 per cent, determined on 1.0 g.
ASSAY
In a flask with a ground-glass stopper, dissolve 1.000 g in 10 mL of ethanol (96 per cent) R. Add
50.0 mL of 0.5 M sodium hydroxide. Close the flask and allow to stand for 1 h. Using 0.2 mL of
phenolphthalein solution R as indicator, titrate with 0.5 M hydrochloric acid. Carry out a blank
titration.
1 mL of 0.5 M sodium hydroxide is equivalent to 45.04 mg of C9H8O4.
STORAGE
In an airtight container.
IMPURITIES
Specified impurities A, B, C, D, E, F.
A. 4-hydroxybenzoic acid,
B. 4-hydroxybenzene-1,3-dicarboxylic acid (4-hydroxyisophthalic acid),
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C. 2-hydroxybenzenecarboxylic acid (salicylic acid),
D. 2-[[2-(acetyloxy)benzoyl]oxy]benzoic acid (acetylsalicylsalicylic acid),
E. 2-[(2-hydroxybenzoyl)oxy]benzoic acid (salsalate, salicylsalicylic acid),
F. 2-(acetyloxy)benzoic anhydride (acetylsalicylic anhydride).
Ph Eur
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