aspirin monograph
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
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