Ephedrine Hydrochloride
Ephedrine Hydrochloride
Ephedrine Hydrochloride
Sulfated ash (2.4.14). Not more than 0.1 per cent, determined
on 1.0 g.
impurity
A : not more than the area of the principal peak
Reference solution. Dissolve 10 mg of ephedrine
in the chromatogram obtained with reference solution (a)
hydrochloride CRS in methanol R and dilute to 5 mL with
(0.2 per cent) ;
the same solvent.
unspecified impurities : for each impurity, not more than
Plate : TLC silica gel plate R.
0.5 times the area of the principal peak in the chromatogram
Mobile phase : methylene chloride R, concentrated
obtained with reference solution (a) (0.1 per cent) ;
ammonia R, 2-propanol R (5:15:80 V/V/V).
sum of impurities other than A : not more than 2.5 times the
Application : 10 L.
area of the principal peak in the chromatogram obtained
Development : over 2/3 of the plate.
with reference solution (a) (0.5 per cent) ;
Drying : in air.
disregard limit : 0.25 times the area of the principal peak
Detection : spray with ninhydrin solution R ; heat at 110 C
in the chromatogram obtained with reference solution (a)
for 5 min.
(0.05 per cent).
Results : the principal spot in the chromatogram obtained
Sulfates (2.4.13) : maximum 100 ppm, determined on
with the test solution is similar in position, colour and size
solution S.
to the principal spot in the chromatogram obtained with
Loss on drying (2.2.32) : maximum 0.5 per cent, determined
the reference solution.
on 1.000 g by drying in an oven at 105 C.
D. To 0.1 mL of solution S (see Tests) add 1 mL of water R,
Sulfated ash (2.4.14): maximum 0.1 per cent, determined on
0.2 mL of copper sulfate solution R and 1 mL of strong
1.0 g.
sodium hydroxide solution R. A violet colour is produced.
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ASSAY
Dissolve 0.170 g in 30 mL of ethanol (96 per cent) R. Add
5.0 mL of 0.01 M hydrochloric acid. Carry out a potentiometric
titration (2.2.20), using 0.1 M sodium hydroxide. Read
the volume added between the two points of inexion.
1 mL of 0.1 M sodium hydroxide corresponds to 20.17 mg of
C10H16ClNO.
STORAGE
Store protected from light.
2143