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Application : 2 L.
Development : over 2/3 of the plate.
Drying : in air ; heat at 110 C for 10 min.
Detection : cool then spray with ninhydrin solution R1 ; heat at
B. R = Cl : 6-chloro-2-ethoxyacridin-9-amine,
110 C for 5 min.
System suitability : reference solution (b) :
C. R = O-CH2-CH2-OH : 2-[(9-amino-7-ethoxyacridin-3yl)oxy]ethanol.
the chromatogram shows 2 clearly separated spots.
Limit :
04/2008:0553
impurity A : any spot due to impurity A in the chromatogram
obtained with test solution (a) is not more intense than
ETHAMBUTOL HYDROCHLORIDE
the spot in the chromatogram obtained with reference
solution (a) (1.0 per cent).
Ethambutoli hydrochloridum
Related substances. Liquid chromatography (2.2.29). Prepare
the solutions immediately before use.
Test solution. Suspend 4.0 mg of the substance to be
examined in 4.0 mL of acetonitrile R1 and add 100 L of
triethylamine R. Sonicate the mixture for 5 min. Add 15 L
of (R)-(+)--methylbenzyl isocyanate R and heat at 70 C for
20 min.
C10H26Cl2N2O2
Mr 277.2 Reference solution (a). Dilute 0.50 mL of the test solution to
[1070-11-7]
100.0 mL with acetonitrile R1.
Reference solution (b). Treat 4.0 mg of ethambutol for system
DEFINITION
(2S,2S)-2,2-(Ethylenediimino)dibutan-1-ol dihydrochloride. suitability CRS (containing impurity B) as described for the
test solution.
Content : 99.0 per cent to 101.0 per cent (dried substance).
Column :
CHARACTERS
size : l = 0.10 m, = 4.6 mm ;
Appearance : white or almost white, crystalline powder,
stationary phase : end-capped octadecylsilyl silica gel for
hygroscopic.
chromatography R (3 m) ;
Solubility : freely soluble in water, soluble in ethanol (96 per
temperature : 40 C.
cent).
Mobile phase :
mobile phase A : methanol R, water R (50:50 V/V) ;
IDENTIFICATION
TESTS
Appearance. It is clear (2.2.1) and colourless (2.2.2, Method II)
when compared with water R. Dilute 1.0 mL to 20 mL with
water R. After standing for 5 min, the dilution remains clear
(2.2.1) when compared with water R.
Acidity or alkalinity. To 20 mL add 20 mL of carbon
dioxide-free water R and 0.1 mL of phenolphthalein solution R.
The solution is colourless. Add 1.0 mL of 0.01 M sodium
hydroxide. The solution is pink (30 ppm, expressed as acetic
acid).
Relative density (2.2.5) : 0.805 to 0.812.
A. 2-aminobutan-1-ol,
Absorbance (2.2.25) : maximum 0.40 at 240 nm, 0.30 between
250 nm and 260 nm and 0.10 between 270 nm and 340 nm.
The absorption curve is smooth.
Examine between 235 nm and 340 nm, in a 5 cm cell using
water R as the compensation liquid.
B. R = CH2-OH, R = H : (2R,2S)-2,2-(ethylenediimino)Volatile impurities. Gas chromatography (2.2.28).
dibutan-1-ol (meso-ethambutol),
Test solution (a). The substance to be examined.
C. R = H, R = CH2-OH : (2R,2R)-2,2-(ethylenediimino)Test solution (b). Add 150 L of 4-methylpentan-2-ol R to
dibutan-1-ol ((R,R)-ethambutol),
500.0 mL of the substance to be examined.
Reference solution (a). Dilute 100 L of anhydrous methanol R
to 50.0 mL with the substance to be examined. Dilute 5.0 mL
of the solution to 50.0 mL with the substance to be examined.
D. 1,2-dichloroethane (ethylene chloride).
Reference solution (b). Dilute 50 L of anhydrous methanol R
and 50 L of acetaldehyde R to 50.0 mL with the substance to
be examined. Dilute 100 L of the solution to 10.0 mL with
01/2008:1317 the substance to be examined.
Reference solution (c). Dilute 150 L of acetal R to 50.0 mL
ETHANOL (96 PER CENT)
with the substance to be examined. Dilute 100 L of the
solution to 10.0 mL with the substance to be examined.
Ethanolum (96 per centum)
Reference solution (d). Dilute 100 L of benzene R to 100.0 mL
with the substance to be examined. Dilute 100 L of the
DEFINITION
solution to 50.0 mL with the substance to be examined.
Content :
Column :
ethanol (C2H6O ; Mr 46.07) : 95.1 per cent V/V (92.6 per
material : fused silica ;
cent m/m) to 96.9 per cent V/V (95.2 per cent m/m)
size : l = 30 m, = 0.32 mm ;
at 20 C, calculated from the relative density using the
alcoholimetric tables (5.5) ;
stationary phase : poly[(cyanopropyl)(phenyl)][dimethyl]siloxane R (lm thickness 1.8 m).
water.
Carrier gas : helium for chromatography R.
CHARACTERS
Linear velocity : 35 cm/s.
Appearance : colourless, clear, volatile, ammable liquid,
Split ratio : 1:20.
hygroscopic.
General Notices (1) apply to all monographs and other texts
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