Packaging and storage
Preserve in tight, light-resistant containers.
Identification
B:
To a solution of 10 mg in 5 mL of water add 1 drop of
ferric chloride TS: an intense green color is produced, and it becomes olive-green on standing.
C:
To a solution of 10 mg in 1 mL of water add 1 drop of
phosphotungstic acid TS: a white precipitate is formed immediately and it becomes brown on standing (
distinction from epinephrine,
which forms no precipitate).
D:
Dilute 1.0 mL of a solution (1 in 1000) with water to 10 mL, add 0.1 mL of dilute hydrochloric acid (1 in 120), then add 1.0 mL of 0.10 N iodine. Allow to stand for 5 minutes, and add 2.0 mL of 0.10 N sodium thiosulfate: a salmon pink color is produced (distinction from norepinephrine, which, at the same pH, about 3, produces no color or at most only a slight pink color).
E:
It responds to the tests for
Sulfate 191.
Chloride 221
A 0.10-g portion shows no more chloride than corresponds to 0.20 mL of 0.020 N hydrochloric acid (0.14%).
Limit of isoproterenone
It meets the requirements of the test for Isoproterenone under Isoproterenol Hydrochloride.
Organic volatile impurities, Method I 467:
meets the requirements.
Assay
Assay preparation
Transfer about 125 mg of Isoproterenol Sulfate, accurately weighed, to a 25-mL volumetric flask, dissolve in sodium bisulfite solution (3 in 1000), dilute with sodium bisulfite solution to volume, and mix. Transfer 5.0 mL of this solution to a 100-mL volumetric flask, dilute with 0.17 N acetic acid to volume, and mix.
Chromatographic system
Proceed as directed for
Procedure in the
Assay under
Isoproterenol Hydrochloride. Calculate the quantity, in mg, of (C
11H
17NO
3)
2·H
2SO
4 in the portion of Isoproterenol Sulfate taken by the formula:
(260.30 / 247.72)(0.5C)(hU / hS),
in which 260.30 is one-half of the molecular weight of anhydrous isoproterenol sulfate, 247.72 is the molecular weight of isoproterenol hydrochloride; and
C,
hU, and
hS are as defined therein.