Packaging and storage—
Preserve in small, tight containers that are well-filled or otherwise protected from oxidation. Protect from light.
Labeling—
Label it to indicate that the Inhalation Solution is not to be used if its color is pinkish or darker than slightly yellow or if it contains a precipitate.
Color and clarity—
Standard solution—
Transfer 2.0 mL of 0.100 N iodine VS to a 500-mL volumetric flask, dilute with water to volume, and mix.
Procedure—
Visually examine a portion of the Inhalation Solution (Test solution) in a suitable clear glass test tube against a white background: it is not pinkish and it contains no precipitate. If any yellow color is observed in the Test solution, concomitantly determine the absorbances of the Test solution and the Standard solution in 1-cm cells with a suitable spectrophotometer set at 460 nm: the absorbance of the Test solution does not exceed that of the Standard solution.
Identification—
The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that of the Standard preparation obtained as directed in the Assay.
Assay—
Assay preparation—
Transfer an accurately measured volume of Inhalation Solution, equivalent to about 25 mg of isoproterenol hydrochloride, to a 100-mL volumetric flask, dilute with 0.17 N acetic acid solution to volume, and mix.
Procedure—
Proceed as directed for
Procedure in the
Assay under
Isoproterenol Hydrochloride. Calculate the quantity, in mg, of C
11H
17NO
3·HCl in each mL of the Inhalation Solution taken by the formula:
0.1(C/V)(hU / hS),
in which
V is the volume, in mL, of Inhalation Solution taken; and
C,
hU, and
hS are as defined therein.
71
:
meets the requirements.