aspirin monograph

Topics: Sodium hydroxide, Chromatography, PH Pages: 2 (1533 words) Published: October 21, 2014
EUROPEAN PHARMACOPOEIA 5.0

Acetylsalicylic acid

TESTS
Appearance of solution. Dissolve 1.0 g in 9 ml of alcohol R. The solution is clear (2.2.1) and colourless (2.2.2, Method II). Related substances. Examine by liquid chromatography
(2.2.29). Prepare the solutions immediately before use.
Test solution. Dissolve 0.10 g of the substance to be
examined in acetonitrile for chromatography R and dilute
to 10.0 ml with the same solvent.
C. N,N′-diacetyl-L-cystine,
Reference solution (a). Dissolve 50.0 mg of salicylic acid R in the mobile phase and dilute to 50.0 ml with the mobile
phase. Dilute 1.0 ml of this solution to 100.0 ml with the
mobile phase.
Reference solution (b). Dissolve 10.0 mg of salicylic acid R in the mobile phase and dilute to 10.0 ml with the mobile
phase. To 1.0 ml of this solution add 0.2 ml of the test
solution and dilute to 100.0 ml with the mobile phase.
D. N,S-diacetyl-L-cysteine.
The chromatographic procedure may be carried out using :
— a stainless steel column 0.25 m long and 4.6 mm in
internal diameter packed with octadecylsilyl silica gel for
01/2005:0309
chromatography R (5 µm),

as
mobile phase at a flow rate of 1 ml/min a mixture
ACETYLSALICYLIC ACID
of 2 volumes of phosphoric acid R, 400 volumes of
acetonitrile for chromatography R and 600 volumes of
Acidum acetylsalicylicum
water R,
— as detector a spectrophotometer set at 237 nm.
Inject 10 µl of each solution. Continue the chromatography
of the test solution for seven times the retention time
of acetylsalicylic acid. The test is not valid unless in the chromatogram obtained with reference solution (b), the
resolution between the two principal peaks is at least 6.0.
C 9 H 8 O4
Mr 180.2 In the chromatogram obtained with the test solution the area of any peak, apart from the principal peak, is not greater DEFINITION
than the area of the principal peak in the chromatogram
obtained with reference solution (a) (0.1 per cent) ; the sum...
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