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Zinc Chloride Injection
» Zinc Chloride Injection is a sterile solution of Zinc Chloride in Water for Injection. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of zinc (Zn).
Packaging and storage
Preserve in single-dose or multiple-dose containers, preferably of Type I or Type II glass.
Labeling
Label the Injection to indicate that it is to be diluted with Water for Injection or other suitable fluid to appropriate strength prior to administration.
Identification
The Assay preparation prepared as directed in the Assay exhibits an absorption maximum at about 213.8 nm, when determined as directed in the Assay.
Bacterial endotoxins
pH
Particulate matter
Other requirements
It meets the requirements under Injections
Assay
[noteThe Standard preparations and the Assay preparation may be diluted quantitatively with water, if necessary, to obtain solutions of suitable concentrations adaptable to the linear or working range of the instrument.]
Sodium chloride solution
Dissolve 450 mg of sodium chloride in water, dilute with water to 500 mL, and mix.
Standard preparations
Transfer 3.11 g of zinc oxide, accurately weighed, to a 250-mL volumetric flask, add 80 mL of 1 N sulfuric acid, warm to dissolve, cool, dilute with water to volume, and mix. This stock solution contains 10.0 mg of zinc per mL. Dilute an accurately measured volume of this solution quantitatively with water to obtain a solution containing 125 µg of zinc per mL. Transfer 2.0, 3.0, and 4.0 mL, respectively, of this solution to three separate 500-mL volumetric flasks, each containing 5 mL of Sodium chloride solution, dilute the contents of each flask with water to volume, and mix. These Standard preparations contain, respectively, 0.50, 0.75, and 1.0 µg of zinc per mL.
Assay preparation
Transfer an accurately measured volume of Injection, equivalent to about 5 mg of zinc, to a 500-mL volumetric flask, dilute with water to volume, and mix. Transfer 10.0 mL of this solution to a 100-mL volumetric flask. From the labeled amount of sodium chloride, if any, in the Injection, calculate the amount, in mg, of sodium chloride in the 10.0-mL portion and add sufficient Sodium chloride solution to bring the total sodium chloride content of the 100-mL volumetric flask to 0.9 mg. Dilute with water to volume, and mix.
Procedure
Concomitantly determine the absorbances of the Standard preparations and the Assay preparation at the zinc emission line at 213.8 nm, with a suitable atomic absorption spectrophotometer (see Spectrophotometry and Light-scattering
5C / V
in which C is the concentration, in µg per mL, of zinc in the Assay preparation; and V is the volume, in mL, of Injection taken.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP32NF27 Page 3895
Pharmacopeial Forum: Volume No. 32(5) Page 1473
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