Manganese Sulfate 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

Manganese Sulfate Injection is a sterile solution of Manganese Sulfate in Water for Injection. It contains NLT 90.0% and NMT 110.0% of the labeled amount of manganese (Mn).

2 IDENTIFICATION

A. The Sample solution, prepared as directed in the Assay, exhibits an absorption maximum at about 279 nm when tested as directed for in the Assay.

3 ASSAY

3.1 PROCEDURE

Solution A: 0.9 mg/mL of sodium chloride

Standard stock solution A: 1 mg/mL of manganese prepared as follows. Transfer 1.000 g of manganese to a 1000-mL volumetric flask, dissolve in 20 mL of nitric acid, and dilute with 0.1 N hy drochloric acid to volume. Store in a polyethylene bottle.

Standard stock solution B: 20 μg/mL of manganese from Standard stock solution A in water

Standard solution A: 1.6 μg/mL of manganese prepared as follows. Transfer 4.0 mL of Standard stock solution B to a 50-mL volumetric flask containing 10 mL of Solution A, and dilute with water to volume.

Standard solution B: 2.0 μg/mL of manganese prepared as follows. Transfer 5.0 mL of Standard stock solution B to a 50-mL volumetric flask containing 10 mL of Solution A, and dilute with water to volume.

Standard solution C: 2.4 μg/mL of manganese prepared as follows. Transfer 6.0 mL of Standard stock solution B to a 50-mL volumetric flask containing 10 mL of Solution A, and dilute with water to volume.

Sample solution: Nominally 0.002 mg/mL of manganese from a volume of Injection in water

3.1.1 Instrumental conditions

(See Atomic Absorption Spectroscopy 〈852〉.)

Mode: Atomic absorption spectrophotometer

Analytical wavelength: Manganese emission line at 279 nm

Source: Manganese hollow-cathode lamp

Flame: Air–acetylene

Blank: 0.18 mg/mL of sodium chloride

3.1.2 Analysis

Samples: Standard solution A, Standard solution B, Standard solution C, Sample solution, and Blank

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

Calculate the percentage of the labeled amount of manganese in the portion of Injection taken:

Result = (C_S/C_U) × 100

C_S = concentration of manganese in the Sample solution, determined from the calibration graph (μg/mL)

C_U = nominal concentration of manganese in the Sample solution (μg/mL)

Acceptance criteria: 90.0%–110.0%

4 SPECIFIC TESTS

Change to read:

BACTERIAL ENDOTOXINS TEST 〈85〉: Meets the requirements (USP 1-May-2023)

PH 〈791〉: 2.0–3.5

PARTICULATE MATTER IN INJECTIONS 〈788〉: It meets the requirements for small-volume injections.

OTHER REQUIREMENTS: It meets the requirements under Injections and Implanted Drug Products 〈1〉.

5 ADDITIONAL REQUIREMENTS

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

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 prior to administration.