Potassium Chloride
(poe tas' ee um klor' ide).
KCl 74.55 Potassium chloride [7447-40-7]. DEFINITION
Potassium Chloride contains NLT 99.0% and NMT 100.5% of KCl, calculated on the dried basis.
IDENTIFICATION
• A. Identification TestsGeneral, Potassium 191
Sample solution:
50 mg/mL
Acceptance criteria:
Meets the requirements
• B. Identification TestsGeneral, Chloride 191
Sample solution:
50 mg/mL
Acceptance criteria:
Meets the requirements
ASSAY
• Procedure
Sample:
200 mg
Analysis:
Dissolve the Sample in 10 mL of water. Add 10 mL of glacial acetic acid, 75 mL of methanol, and 3 drops of eosin Y TS. Titrate, with shaking, with 0.1 N silver nitrate VS to a pink endpoint. Each mL of 0.1 N silver nitrate is equivalent to 7.455 mg of KCl.
Acceptance criteria:
99.0%100.5% on the dried basis
IMPURITIES
• Aluminum 206 (where it is labeled as intended for use in hemodialysis):
Proceed as directed, using 2.0 g of Potassium Chloride to prepare the Test preparation.
Acceptance criteria:
NMT 1 ppm
• Sodium
Sample solution:
50 mg/mL
Acceptance criteria:
Sample solution tested on a platinum wire does not impart a pronounced yellow color to a nonluminous flame.
• Iodide
Standard stock solution:
1.64 mg/mL of potassium iodide in water
Standard solution:
Dilute 1.0 mL of Standard stock solution with water to 25 mL. Dilute 2.0 mL of this solution with water to 8 mL. Add 1 mL each of chloroform and diluted hydrochloric acid, then add 2 drops of a chloramine T solution (0.1 in 100), and shake gently.
Sample solution:
Dissolve 2 g of Potassium Chloride in 8 mL of water. Add 1 mL each of chloroform and diluted hydrochloric acid, then add 2 drops of a chloramine T solution (0.1 in 100), and shake gently.
Acceptance criteria:
The violet color of the chloroform layer is not darker than that of a concomitantly prepared Standard solution (NMT 0.005%).
• Bromide
Standard stock solution:
1.28 mg/mL of sodium bromide in water
Standard solution:
Dilute 2.0 mL of Standard stock solution with water to 8 mL. Add 1 mL each of chloroform and diluted hydrochloric acid, then add 5 drops of a chloramine T solution (1 in 100), and shake gently.
Sample solution:
Dissolve 2 g of Potassium Chloride in 8 mL of water. Add 1 mL each of chloroform and diluted hydrochloric acid, then add 5 drops of a chloramine T solution (1 in 100), and shake gently.
Acceptance criteria:
The brown color of the chloroform layer is not darker than that of a concomitantly prepared Standard solution (NMT 0.1%).
• Calcium and Magnesium
Sample solution:
10 mg/mL in water
Analysis:
To 20 mL of Sample solution add 2 mL each of 6 N ammonium hydroxide, ammonium oxalate TS, and dibasic sodium phosphate TS.
Acceptance criteria:
No turbidity is produced within 5 min.
SPECIFIC TESTS
• Acidity or Alkalinity:
To a solution of 5.0 g in 50 mL of carbon dioxide-free water add 3 drops of phenolphthalein TS: no pink color is produced. Then add 0.30 mL of 0.020 N sodium hydroxide: a pink color is produced.
• Loss on Drying 731:
Dry a sample at 105 for 2 h: it loses NMT 1.0% of its weight.
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in well-closed containers.
• Labeling:
Where Potassium Chloride is intended for use in hemodialysis, it is so labeled.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 4359
Pharmacopeial Forum: Volume No. 29(5) Page 1562
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