Specific activity:
not less than 2.96 MBq (80 µCi) per mg of strontium at the time indicated in the labeling.
Packaging and storage—
Preserve in single-dose containers that are adequately shielded.
Labeling—
Label it to include the following, in addition to the information specified for
Labeling under
Injections 
1
: the time and date of calibration; the amount of strontium chloride expressed as mg of strontium per mL; the amount of
89Sr as labeled strontium chloride expressed as total megabecquerels (or millicuries) and concentration as megabecquerels per mL (or millicuries per mL) on the date and time of calibration; the expiration date; and the statement “Caution—Radioactive Material.” The labeling indicates that in making dosage calculations, correction is to be made for radioactive decay, and also indicates that the radioactive half-life of
89Sr is 50.5 days.
Radionuclide identification (see Radioactivity 821)—
Strontium 89 decays by beta emission to stable Yttrium 89 with 0.01% of disintegrations going via the metastable daughter
89mY with a half-life of 16 seconds, with which it rapidly establishes radioactive equilibrium. Its gamma-ray spectrum is identical to that of a specimen of strontium 89 in equilibrium with
89mY exhibiting bremsstrahlung and a gamma photopeak of 0.909 MeV.
[NOTE—Use a plastic container to perform measurements.
]
Bacterial endotoxins 85—
It meets the requirements, the limit of endotoxin content being not more than 175/
V USP Endotoxin Unit per mL of the Injection, when compared with the USP Endotoxin RS, in which
V is the maximum recommended total dose, in mL, at the expiration date or time.
Radionuclidic purity—
[NOTE—Use a plastic container to perform the following test.
] Using a suitable counting assembly (see
Assay,
Gamma-Emitting Radionuclides, under
Radioactivity 821), determine the radioactivity of each gamma-emitting radionuclidic impurity, in kBq per MBq (or µCi per mCi) of
89Sr, in the Injection by use of a calibrated system as directed under
Radioactivity 821. The total activity of all gamma-emitting impurities is not greater than 370 kBq per 37 MBq (or 10 µCi per mCi) of
89Sr at the expiration date stated in the labeling.
Chemical purity (Limit of aluminum)—
[NOTE—The
Standard preparations and the
Test preparation may be modified, if necessary, to obtain solutions of suitable concentrations adaptable to the linear or working range of the instrument.
]
Nitric acid diluent—
Dilute 40 mL of nitric acid with water to 1000 mL.
Standard preparations—
Transfer 2000 mg of aluminum metal to a 1000-mL volumetric flask, add 50 mL of 6 N hydrochloric acid, swirl to ensure contact of the aluminum and the acid, and allow the reaction to proceed until all of the aluminum has dissolved. Dilute with water to volume, and mix. Transfer 5.0 mL of this solution to a 1000-mL volumetric flask, dilute with water to volume, and mix. Transfer 10.0 mL of this solution to a 100-mL volumetric flask, dilute with Nitric acid diluent to volume, and mix. Transfer 1.0-, 2.0-, and 4.0-mL portions of this solution to separate 100-mL volumetric flasks, dilute with Nitric acid diluent to volume, and mix. These solutions contain 0.01, 0.02, and 0.04 µg of Al per mL, respectively.
Test preparation—
Transfer 1.0 mL of Injection to a 100-mL volumetric flask, and carefully add 4 mL of nitric acid. Dilute with water to volume, and mix.
Procedure—
Determine the absorbances of the
Standard preparations and the
Test preparation at the aluminum emission line at 309.3 nm with an atomic absorption spectrophotometer (see
Spectrophotometry and Light-Scattering 851) equipped with an aluminum hollow-cathode lamp and a flameless electrically heated furnace, using
Nitric acid diluent as the blank. Plot the absorbances of the
Standard preparations versus the contents of Al, in µg per mL, drawing the straight line best fitting the three points. From the graph so obtained, determine the quantity, in µg, of Al in each mL of the
Test preparation. Calculate the quantity, in µg per g, of Al in the specimen taken by multiplying this value by 100: the limit is 2 µg per g.
Assay for radioactivity—
Using a suitable counting assembly (see
Assay,
Gamma-Emitting Radionuclides, under
Radioactivity 821), determine the radioactivity, in MBq (or mCi) per mL, of the Injection by use of a calibrated system as directed under
Radioactivity 821.
Other requirements—
It meets the requirements under
Injections 1, except that it is not subject to the recommendation on
Volume in Container.
Assay—
Potassium chloride solution—
Dissolve 1.9 g of potassium chloride in water, dilute with water to 1000 mL, and mix. This solution contains 1000 µg of potassium per mL.
Strontium stock solution—
Transfer 1.685 g of strontium carbonate, accurately weighed, to a 100-mL volumetric flask, and add water to dissolve. Add 10 mL of hydrochloric acid, dilute with water to volume, and mix to obtain a solution containing 10,000 µg of strontium per mL.
Standard preparations—
Pipet 10 mL of Strontium stock solution into a 100-mL volumetric flask. Add 10 mL of hydrochloric acid, dilute with Potassium chloride solution to volume, and mix. Transfer 10 mL and 20 mL, respectively, of this solution into separate 100-mL volumetric flasks, dilute with Potassium chloride solution to volume, and mix. These Standard preparations contain 100 and 200 µg of strontium per mL.
Assay preparation—
Pipet 0.1 mL of Injection into a small beaker. Add 5 mL of Potassium chloride solution, and mix.
Procedure—
Concomitantly determine the absorbances of the
Standard preparations and the
Assay preparation at the strontium emission line of 407.8 nm with an atomic absorption spectrophotometer (see
Spectrophotometry and Light-Scattering 851) equipped with a strontium hollow-cathode lamp and a nitrous oxide–acetylene flame, using
Potassium chloride solution as the blank. Plot the absorbances of the
Standard preparations versus concentration, in µg per mL, of strontium, and draw the straight line best fitting the four plotted points. From the graph so obtained, determine the concentration, in µg per mL, of strontium in the
Assay preparation. Calculate the quantity, in µg, of strontium in each mL of the Injection taken by the formula:
51C,
in which
C is the concentration, in µg per mL, of strontium in the
Assay preparation.
