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FAMOTIDINE
Famotidinum
Mobile phase A
(per cent V/V)
100 96
Mobile phase B
(per cent V/V)
04
Flow rate
(mL/min)
1
23 - 27
96
12
27 - 47
96 78
4 22
disregard
limit : 0.5 times the area of the principal peak in
mobile phase A.
the chromatogram obtained with reference solution (a)
Reference solution (a). Dilute 1.0 mL of the test solution to
(0.05 per cent).
100.0 mL with mobile phase A. Dilute 1.0 mL of this solution
Heavy metals (2.4.8): maximum 10 ppm.
to 10.0 mL with mobile phase A.
Solvent mixture : dimethylformamide R, water R (30:70 V/V).
Reference solution (b). Dissolve 2.5 mg of famotidine
impurity D CRS in methanol R and dilute to 10.0 mL with the 0.5 g complies with test H. Prepare the reference solution
using 0.5 mL of lead standard solution (10 ppm Pb) R.
same solvent. To 1.0 mL of the solution add 0.50 mL of the
test solution and dilute to 100.0 mL with mobile phase A.
Loss on drying (2.2.32) : maximum 0.5 per cent, determined
Reference solution (c). Dissolve 5.0 mg of famotidine for system on 1.000 g by drying in an oven at 80 C at a pressure not
suitability CRS (containing impurities A, B, C, D, F and G) in exceeding 670 Pa for 5 h.
mobile phase A and dilute to 10.0 mL with mobile phase A.
Sulfated ash (2.4.14): maximum 0.1 per cent, determined on
1.0 g.
Column :
size : l = 0.25 m, = 4.6 mm ;
ASSAY
stationary phase : end-capped octadecylsilyl silica gel for
Dissolve 0.120 g in 60 mL of anhydrous acetic acid R. Titrate
chromatography R (5 m) ;
with 0.1 M perchloric acid, determining the end-point
potentiometrically (2.2.20).
temperature : 50 C.
C8H15N7O2S3
[76824-35-6]
2211
A. 3-[[[2-[(diaminomethylidene)amino]thiazol-4yl]methyl]sulfanyl]propanimidamide,
B. 3,5-bis[2-[[[2-[(diaminomethylidene)amino]thiazol4-yl]methyl]sulfanyl]ethyl]-4H-1,2,4,6-thiatriazine
1,1-dioxide,
I. 3-[[[2-[(diaminomethylidene)amino]thiazol-4yl]methyl]sulnyl]-N-sulfamoylpropanamide,
J. methyl 3-[[[2-[(diaminomethylidene)amino]thiazol-4yl]methyl]sulfanyl]propanoate.
01/2008:2176
corrected 6.0
C20H22N4O6S
[58306-30-2]
D. 3-[[[2-[(diaminomethylidene)amino]thiazol-4yl]methyl]sulfanyl]propanamide,
Mr 446.5
DEFINITION
Dimethyl N,N-[[[2-[(methoxyacetyl)amino]-4(phenylsulfanyl)phenyl]imino]methylene]dicarbamate.
Content : 97.5 per cent to 102.0 per cent (dried substance).
E. 2,2-[disulfanediylbis(methylenethiazole-4,2diyl)]diguanidine,
CHARACTERS
Appearance : white or almost white, crystalline powder.
Solubility : practically insoluble in water, soluble in acetone,
slightly soluble in anhydrous ethanol.
It shows polymorphism (5.9).
F. 3-[[[2-[(diaminomethylidene)amino]thiazol-4yl]methyl]sulfanyl]propanoic acid,
IDENTIFICATION
Infrared absorption spectrophotometry (2.2.24).
Comparison : febantel CRS.
If the spectra obtained in the solid state show differences,
dissolve the substance to be examined and the reference
substance separately in acetone R, evaporate to dryness and
record new spectra using the residues.
2212