Cupric Chloride 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

Cupric Chloride Injection is a sterile solution of Cupric Chloride in Water for Injection. It contains NLT 90.0% and NMT 110.0% of the labeled amount of copper (Cu).

2 IDENTIFICATION

A. The Sample solution exhibits an absorption maximum at about 325 nm when prepared and tested as directed in the Assay.

3 ASSAY

Change to read:

3.1 PROCEDURE

Sodium chloride solution: 1.35 g/L of sodium chloride

Standard stock solution: Transfer 1.000 g of copper to a 1000-mL volumetric flask, dissolve in 20 mL of nitric acid, and dilute with 0.2 N nitric acid to volume. This solution contains 1000 µg/mL of copper. Store in a polyethylene bottle.

Standard solutions: Pipet 15 mL of Standard stock solution into a 250-mL volumetric flask, dilute with water to volume, and mix. Transfer 4.0, 5.0, and 6.0 mL of this solution to separate 100-mL volumetric flasks containing 10 mL of Sodium chloride solution, dilute the contents of each flask with water to volume, and mix. These Standard solutions contain 2.4, 3.0, and 3.6 µg of copper per mL, respectively.

Sample stock solution: Transfer a volume of Injection, equivalent to 2 mg of copper, into 100 mL of water.

Sample solution: Pipet 15 mL of the Sample stock solution into a 100-mL volumetric flask. From the labeled amount of sodium chloride, if any, in the Injection, calculate the amount, in mg, of sodium chloride in the initial dilution, and add sufficient Sodium chloride solution to bring the

total sodium chloride (ERR 1-Dec-2018) content of this flask to 13.5 mg. Dilute with water to volume.

Instrumental conditions

(See Atomic Absorption Spectroscopy (852).)

Mode: Atomic absorption

Analytical wavelength: 324.8 nm (copper emission line)

Lamp: Copper hollow-cathode

Flame: Air-acetylene

Blank: Sodium chloride solution and water (1 in 10)

Analysis

Samples: Standard solutions and Sample solution

Plot the absorbances of the Standard solutions versus concentration, in µg/mL, of copper, and draw the straight line best fitting the three plotted points. From the graph so obtained, determine the concentration, C, in µg/mL, of copper in the Sample solution.

Calculate the percentage of copper in the portion of Injection taken:

Result = [(C/V) x F x V₁ x D] x (100/L)

C = concentration of copper in the Sample solution (µg/mL)

V = volume of Injection (mL)

F = conversion factor from µg to mg, 1/1000

V₁ = volume of the Sample stock solution, 100 mL

D = dilution factor from the Sample solution, 100/15

L = label claim (mg/mL)

Acceptance criteria: 90.0%-110.0%

4 SPECIFIC TESTS

4.1 PH (791):

1.5-2.5

4.2 BACTERIAL ENDOTOXINS TEST (85):

It contains NMT 250.0 USP Endotoxin Units/mg of copper.

4.3 PARTICULATE MATTER IN INJECTIONS (788):

Meets the requirements for small-volume injections

4.4 OTHER REQUIREMENTS:

Meets the requirements in Injections and Implanted Drug Products (1)

5 ADDITIONAL REQUIREMENTS

5.1 PACKAGING AND STORAGE:

Preserve in single-dose or multiple-dose containers, preferably of Type I or Type II glass.

5.2 LABELING:

Label the Injection to indicate that it is to be diluted to the appropriate strength with Sterile Water for Injection or other suitable fluid before administration.