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Manganese Chloride for Oral Solution
» Manganese Chloride for Oral Solution contains not less than 90.0 percent and not more than 110.0 percent 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 191 and for Manganese 191.
Uniformity of dosage units 905—
FOR POWDER PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.
Deliverable volume 698—
FOR POWDER PACKAGED IN MULTIPLE-UNIT CONTAINERS: meets the requirements.
pH 791: between 6.0 and 8.0, when constituted to 300 mL with water.
Osmolarity 785: 230 mOsmol pH 6.0 to 8.0.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay—
Sodium chloride solution, Manganese stock solution, and Standard preparations— Prepare as directed in the Assay under Manganese Chloride Injection.
Assay preparation— Constitute the Manganese Chloride for Oral Solution as directed in the labeling. Transfer about 25 mL, accurately measured, of the constituted Manganese Chloride for Oral Solution to a 100-mL volumetric flask, dilute with water to volume, and mix. Proceed as directed for Assay preparation in the Assay under Manganese Chloride Injection, beginning with “Pipet 10 mL of this solution.”
Procedure— Proceed as directed in the Assay under Manganese Chloride Injection. Calculate the quantity, in µg, of manganese in each mL of the constituted for Oral Solution taken by the formula:
500C/V,
in which C is the concentration, in µg per mL, of the manganese in the Assay preparation; and V is 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 : (RMI05) Radiopharmaceuticals and Medical Imaging Agents 05
USP29–NF24 Page 1309
Pharmacopeial Forum : Volume No. 29(6) Page 1922
Phone Number : 1-301-816-8305