Potassium Chloride in Sodium Chloride Injection
» Potassium Chloride in Sodium Chloride Injection is a sterile solution of Potassium Chloride and Sodium Chloride in Water for Injection. It contains not less than 95.0 percent and not more than 110.0 percent of the labeled amounts of potassium (K) and chloride (Cl) and not less than 95.0 percent and not more than 105.0 percent of the labeled amount of sodium (Na). It contains no antimicrobial agents.
Packaging and storage—
Preserve in single-dose containers, preferably of Type I or Type II glass, or of a suitable plastic.
Labeling—
The label states the potassium, sodium, and chloride contents in terms of milliequivalents in a given volume. The label states also the total osmolar concentration in mOsmol per L. Where the contents are less than 100 mL, the label alternatively may state the total osmolar concentration in mOsmol per mL.
USP Reference standards 
11
—
11—
USP Endotoxin RS
Identification—
A:
It responds to the flame test for Sodium 191.
191.
B:
To 2 mL of Injection add 5 mL of sodium cobaltinitrite TS: a yellow precipitate is formed immediately. If necessary, centrifuge the solution and examine the precipitate (presence of potassium).
C:
It responds to the tests for Chloride 191.
191.
Bacterial endotoxins 85—
It contains not more than 0.5 USP Endotoxin Unit per mL.
85—
It contains not more than 0.5 USP Endotoxin Unit per mL.
pH 791:
between 3.5 and 6.5.
791:
between 3.5 and 6.5.
Heavy metals 231—
Transfer to a suitable vessel a volume, in mL, of Injection, calculated to two significant figures by the formula:
231—
Transfer to a suitable vessel a volume, in mL, of Injection, calculated to two significant figures by the formula:
0.2/[(GKLK) + (GSLS)]
in which GK and GS are the labeled amounts, in g, of potassium chloride and sodium chloride, respectively, in each 100 mL of Injection, and LK and LS are the limits, in percentage, for Heavy metals specified under Potassium Chloride and Sodium Chloride, respectively. Adjust the volume by evaporation or addition of water to 25 mL, as necessary: it passes the test.
Other requirements—
It meets the requirements under Injections 1.
1.
Assay for potassium and sodium—
Internal standard solution—
Transfer 1.04 g of lithium nitrate to a 1000-mL volumetric flask, add a suitable nonionic surfactant, then add water to volume, and mix.
Potassium stock solution—
Transfer 18.64 g of potassium chloride, previously dried at 105
for 2 hours and accurately weighed, to a 250-mL volumetric flask, add water to volume, and mix. Each mL of this stock solution contains 39.10 mg (1 mEq) of potassium.
for 2 hours and accurately weighed, to a 250-mL volumetric flask, add water to volume, and mix. Each mL of this stock solution contains 39.10 mg (1 mEq) of potassium.
Sodium stock solution—
Transfer 14.61 g of sodium chloride, previously dried at 105 for 2 hours and accurately weighed, to a 250-mL volumetric flask, add water to volume, and mix.
for 2 hours and accurately weighed, to a 250-mL volumetric flask, add water to volume, and mix.
Stock standard preparation—
Transfer 0.1J mL of Potassium stock solution and 0.1J¢ mL of Sodium stock solution to a 100-mL volumetric flask, J and J¢ being the labeled amounts, in mEq per liter, of potassium and sodium, respectively, in the Injection. Dilute with water to volume, and mix. Each mL of this solution contains 0.0391J mg of potassium (K) and 0.02299J¢ mg of sodium (Na).
Standard preparation—
Transfer 5.0 mL of Stock standard preparation to a 500-mL volumetric flask, dilute with Internal standard solution to volume, and mix.
Assay preparation—
Transfer 5.0 mL of Injection to a 500-mL volumetric flask, dilute with Internal standard solution to volume, and mix.
Procedure—
Using a suitable flame photometer, adjusted to read zero with Internal standard solution, concomitantly determine the flame emission readings for the Standard preparation and the Assay preparation at the wavelengths of maximum emission for potassium, sodium, and lithium (766 nm, 589 nm, and 671 nm, respectively). Calculate the quantity, in mg, of K in each mL of the Injection taken by the formula:
C(RU,766 / RU,671)(RS,671 / RS,766)
in which C is the concentration, in mg per mL, of potassium in the Stock standard preparation, RU,766 and RU,671 are the emission readings at the wavelengths identified by the subscript numbers obtained from the Assay preparation, and RS,671 and RS,766 are the emission readings at the wavelengths identified by the subscript numbers obtained from the Standard preparation. Each mg of potassium is equivalent to 0.02558 mEq of potassium. Calculate the quantity, in mg, of Na in each mL of the Injection taken by the formula:
C(RU,589 / RU,671)(RS,671 / RS,589)
in which C is the concentration, in mg per mL, of sodium in the Stock standard preparation, RU,589 and RU,671 are the emission readings at the wavelengths identified by the subscript numbers obtained for the Assay preparation, and RS,671 and RS,589 are the emission readings at the wavelengths identified by the subscript numbers obtained from the Standard preparation. Each mg of sodium is equivalent to 0.04350 mEq of sodium.
Assay for chloride—
Transfer an accurately measured volume of Injection, equivalent to about 55 mg of chloride, to a conical flask, and 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 3.545 mg of Cl. Each mg of chloride is equivalent to 0.0282 mEq of Cl.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Mary S. Waddell
Scientific Liaison 1-301-816-8124 |
(SM42010) Monographs - Small Molecules 4 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
|
| 85 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
USP35–NF30 Page 4365
Pharmacopeial Forum: Volume No. 27(4) Page 2774