Potassium Chloride in Dextrose Injection

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

Potassium Chloride in Dextrose Injection is a sterile solution of Potassium Chloride and Dextrose in Water for Injection. It contains NLT 95.0% and NMT 110.0% of the labeled amount of potassium chloride (KCl) and NLT 95.0% and NMT 105.0% of the labeled amount of dextrose (C₆H₁₂O₆ · H₂O). It contains no antimicrobial agents.

2 IDENTIFICATION

A.

Sample solution: Nominally 50 mg/mL of dextrose from a suitable volume of Injection in water

Analysis: Add a few drops of the Sample solution to 5 mL of hot alkaline cupric tartrate TS.

Acceptance criteria: A copious red precipitate of cuprous oxide is formed.

B. The sample imparts a violet color to a nonluminous flame. Since the presence of small quantities of sodium masks the color, screen out the yellow color produced by the sodium by viewing through a blue filter that blocks emission at 589 nm (sodium) but is transparent to emission at 404 nm (potassium). [Note - Traditionally, cobalt glass has been used, but other suitable filters are commercially available.]

C. Identification Tests - General 〈191〉, Chloride: Meets the requirements

3 ASSAY

3.1 Dextrose

Sample solution: Nominally 20–50 mg/mL of dextrose from Injection prepared as follows. Transfer a volume of Injection, containing 2–5 g of dextrose, to a 100-mL volumetric flask. Add 0.2 mL of 6 N ammonium hydroxide and dilute with water to volume.

Analysis

Sample: Sample solution

Determine the angular rotation in a suitable polarimeter tube (see Optical Rotation 〈781〉).

Calculate the percentage of the labeled amount of dextrose (C₆H₁₂O₆ · H₂O) in the portion of Injection taken:

Result = [(100 × a)/(l × α)] × (1/C_U) × (M_r1/M_r2) × 100

a = observed angular rotation of the Sample solution (°)

l = length of the polarimeter tube (dm)

α = midpoint of the specific rotation range for anhydrous dextrose, 52.9°

C_U = nominal concentration of dextrose in the Sample solution (g/100 mL)

M_r1 = molecular weight of dextrose monohydrate, 198.17

M_r2 = molecular weight of anhydrous dextrose, 180.16

Acceptance criteria: 95.0%–105.0%

3.2 Potassium Chloride

Sample solution: Transfer a volume of Injection, equivalent to 75–150 mg of potassium chloride, to a conical flask. Add water, if necessary, to bring the volume to 10 mL, and add 10 mL of glacial acetic acid, 75 mL of methanol, and 3 drops of eosin Y TS.

Titrimetric system

Mode: Direct titration

Titrant: 0.1 N silver nitrate VS

Endpoint detection: Visual

Indicator: Eosin Y TS

Analysis

Sample: Sample solution

Titrate, with shaking, with Titrant to a pink endpoint.

Calculate the percentage of the labeled amount of potassium chloride (KCl) in the portion of Injection taken:

Result = V × N × (F/W) × 100

V = Titrant volume consumed by the Sample solution (mL)

N = actual normality of the Titrant (mEq/mL)

F = equivalency factor, 74.55 mg/mEq

W = nominal amount of potassium chloride in the Sample solution (mg)

Acceptance criteria: 95.0%–110.0%

4 IMPURITIES

Limit of 5-Hydroxymethylfurfural and Related Substances

Sample solution: Nominally 2.0 mg/mL of dextrose from Injection in water

Instrumental conditions

Mode: UV

Analytical wavelength: 284 nm

Cell: 1 cm

Blank: Water

Analysis

Samples: Sample solution and Blank

Determine the absorbance of the Sample solution.

Acceptance criteria: NMT 0.25

5 SPECIFIC TESTS

Bacterial Endotoxins Test 〈85〉: NMT 0.5 USP Endotoxin Units/mL

pH 〈791〉

Sample solution: Nominally 5% of dextrose from a portion of Injection in water

Acceptance criteria: 3.5–6.5

Other Requirements: It meets the requirements under Injections and Implanted Drug Products 〈1〉.

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in single-dose glass or plastic containers. Glass containers are preferably Type I or Type II.

Labeling: The label states the total osmolar concentration in mOsmol/L. Where the contents are less than 100 mL, or where the label states that the Injection is not for direct injection but is to be diluted before use, the label alternatively may state the total osmolar concentration in mOsmol/mL. The content of potassium, in mEq, is prominently displayed on the label.