Manganese Chloride for Oral Solution
»Manganese Chloride for Oral Solution contains not less than 90.0percent and not more than 110.0percent of the labeled amount of manganese (Mn).It may contain one or more suitable flavors,sweetening agents,thickening agents,and stabilizers.
Packaging and storage— Preserve in tight,light-resistant,single-dose containers.
Labeling— The label contains directions for constitution of the powder and states the amount of manganese in a given volume of the Oral Solution obtained after constitution.
Identification— It meets the requirements of the tests for Chloride á191ñand for Manganese á191ñ.
Uniformity of dosage units á905ñ—
FOR POWDER PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.
Deliverable volume á698ñ—
FOR POWDER PACKAGED IN MULTIPLE-UNIT CONTAINERS: meets the requirements.
pHá791ñ: between 6.0and 8.0,when constituted to 300mLwith water.
Osmolarity á785ñ: 230mOsmol pH6.0to 8.0.
Assay—
Sodium chloride solution,Manganese stock solution,and Standard preparations— Prepare as directed in the Assayunder Manganese Chloride Injection.
Assay preparation— Constitute the Manganese Chloride for Oral Solution as directed in the labeling.Transfer about 25mL,accurately measured,of the constituted Manganese Chloride for Oral Solution to a 100-mLvolumetric flask,dilute with water to volume,and mix.Proceed as directed for Assay preparationin the Assayunder Manganese Chloride Injection,beginning with “Pipet 10mLof this solution.”
Procedure— Proceed as directed in the Assayunder Manganese Chloride Injection.Calculate the quantity,in µg,of manganese in each mLof the constituted Manganese Chloride for Oral Solution taken by the formula:
500C/V,
in which Cis the concentration,in µg per mL,of the manganese in the Assay preparation;and Vis the volume,in mL,of the constituted Manganese Chloride for Oral Solution taken.
Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents
USP28–NF23Page 1181
Pharmacopeial Forum:Volume No.29(6)Page 1922
Phone Number:1-301-816-8305
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