Potassium Perchlorate Capsules
» Potassium Perchlorate Capsules contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of potassium perchlorate (KClO4).
Packaging and storage— Preserve in tight, light-resistant containers.
Identification—
A: Dissolve the contents of 5 Capsules in 20 mL of water, and filter: the filtrate responds to the tests for Potassium 191.
B: Add a few drops of methylene blue solution (1 in 1000) to the filtrate obtained in Identification test A: a violet-colored precipitate is obtained.
Disintegration 701: 30 minutes, 1 N hydrochloric acid maintained at 37 ± 2 being used as the immersion fluid.
Uniformity of dosage units 905: meet the requirements for Content Uniformity.
Assay—
Mobile phase, Standard preparation, and Chromatographic system Proceed as directed in the Assay under Potassium Perchlorate.
Assay preparation— Mix the contents of not less than 10 Capsules, and transfer an accurately weighed portion of the mixed powder, equivalent to about 200 mg of potassium perchlorate, to a 200-mL volumetric flask, dilute with water to volume, and mix. Pass through a filter having 0.22-µm pore size, transfer 10.0 mL of the clear filtrate to a 100-mL volumetric flask, dilute with water to volume, and mix.
Procedure— Proceed as directed in the Assay under 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— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Hariram Ramanathan, M.S.
Associate Scientific Liaison
1-301-816-8313
(SM42010) Monographs - Small Molecules 4
701 Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison
1-301-816-8106
(GCDF2010) General Chapters - Dosage Forms
USP35–NF30 Page 4376