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.
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.
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/Vin 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.
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USP35NF30 Page 3763Pharmacopeial Forum: Volume No. 29(6) Page 1922