Potassium Perchlorate Capsules
»Potassium Perchlorate Capsules contain not less than 90.0percent and not more than 110.0percent of the labeled amount of potassium perchlorate (KClO4).
Packaging and storage— Preserve in tight,light-resistant containers.
Identification—
A: Dissolve the contents of 5Capsules in 20mLof water,and filter:the filtrate responds to the tests for Potassium á191ñ.
B: Add a few drops of methylene blue solution (1in 1000)to the filtrate obtained in Identificationtest A:a violet-colored precipitate is obtained.
Disintegration á701ñ: 30minutes,1Nhydrochloric acid maintained at 37±2being used as the immersion fluid.
Assay—
Mobile phase,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder Potassium Perchlorate.
Assay preparation— Mix the contents of not less than 10Capsules,and transfer an accurately weighed portion of the mixed powder,equivalent to about 200mg of potassium perchlorate,to a 200-mLvolumetric flask,dilute with water to volume,and mix.Pass through a filter having 0.22-µm pore size,transfer 10.0mLof the clear filtrate to a 100-mLvolumetric flask,dilute with water to volume,and mix.
Procedure— Proceed as directed in the Assayunder Potassium Perchlorate.Calculate the quantity,in mg,of potassium perchlorate (KClO4)in the portion of Capsules taken by the formula:
2000C(rU/rS),
in which the terms are as defined therein.
Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents
USP28–NF23Page 1598
Phone Number:1-301-816-8305