Superiority:
Dihydrostreptomycin sulphate for veterinary use is
bis[N,N′-bis(aminoiminomethyl)-4-O-[5-deoxy-2-O-[2-deoxy-2-
(methylamino)-α-L-glucopyranosyl]-3-C-(hydroxymethyl)-α-
L-lyxofuranosyl]-D-streptamine] tris(sulphate), the sulphate
of a substance obtained by catalytic hydrogenation of
streptomycin or by any other means. Stabilisers may be
added. The potency is not less than 730 IU/mg, calculated
with reference to the dried substance.
Details:
IDENTIFICATION
A. Examine by thin-layer chromatography (2.2.27) using
a plate coated with a 0.75 mm layer of the following
mixture: mix 0.3 g of carbomer R with 240 ml of water R
and allow to stand, with moderate shaking, for 1 h ; adjust
to pH 7 by the gradual addition, with continuous shaking,
of dilute sodium hydroxide solution R and add 30 g of
silica gel H R.
Heat the plate at 110 °C for 1 h, allow to cool and use
immediately.
Test solution. Dissolve 10 mg of the substance to be
examined in water R and dilute to 10 ml with the same
solvent.
Reference solution (a). Dissolve 10 mg of
dihydrostreptomycin sulphate CRS in water R and dilute
to 10 ml with the same solvent.