Pancuronium Bromide 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

Pancuronium Bromide Injection is a sterile solution containing NLT 92.0% and NMT 105.0% of the labeled amount of pancuronium bromide (C₃₅H₆₀Br₂N₂O₄) in Water for Injection. It contains a suitable tonicity-adjusting agent.

2 IDENTIFICATION

A. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

3 ASSAY

3.1 PROCEDURE

Mobile phase: Acetonitrile, methanol, and 0.024 M hydrochloric acid (125:220:655)

Diluent: 0.0024 M hydrochloric acid

Standard stock solution: 1.0 mg/mL of USP Pancuronium Bromide RS prepared as follows. Transfer the required quantity of USP Pancuronium Bromide RS to a suitable volumetric flask. Dissolve in 2% of the flask volume of acetonitrile. Dilute with Diluent to volume. Sonicate for 3 min.

Standard solution: 0.1 mg/mL of USP Pancuronium Bromide RS from the Standard stock solution and Diluent

Sample solution: Nominally 0.1 mg/mL of pancuronium bromide from a suitable volume of Injection in Diluent

3.2 Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: Conductivity with suppression

Column: 4.6-mm x 25-cm; 5-µm packing L1

Temperatures

Detector: 40°

Column: 35°

Suppressor: 4-mm cationic membrane suppressor or equivalent

Suppression solution: 0.15 M tetrabutylammonium hydroxide

Suppressor flow rate: 1 mL/min

Flow rate: 0.75 mL/min

Injection volume: 25 µL

Run time: 2 times the retention

3.3 System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 1.0%

3.4 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of pancuronium bromide (C₃₅H₆₀Br₂N₂O₄) in the portion of Injection taken:

Result = (r_U/r_S) x (C_S/C_U) x 100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

C_S = concentration of USP Pancuronium Bromide RS in the Standard solution (mg/mL)

C_U = nominal concentration of pancuronium bromide in the Sample solution (mg/mL)

Acceptance criteria: 92.0%-105.0%

4 IMPURITIES

ORGANIC IMPURITIES

Diluent, Standard stock solution, and Chromatographic system: Proceed as directed in the Assay.

Mobile phase: Acetonitrile, methanol, and 0.024 M hydrochloric acid (125:180:695)

System suitability solution: 1 mg/mL of USP Pancuronium Bromide RS and 0.02 mg/mL each of USP Pancuronium Bromide Related Compound A RS, USP Pancuronium Bromide Related Compound B RS, USP Pancuronium Bromide Related Compound C RS, and USP Vecuronium Bromide RS prepared as follows. Transfer the required amounts of the individual components to a suitable volumetric flask. Dissolve in 2% of the flask volume of acetonitrile, and dilute with Diluent to volume. Sonicate for 3 min.

Standard solution: 0.02 mg/mL of USP Pancuronium Bromide RS from the Standard stock solution and Diluent

Sample solution: Nominally 1.0 mg/mL of pancuronium bromide from a suitable volume of Injection in Diluent

System suitability

Samples: System suitability solution and Standard solution

[NOTE-See Table 1 for the relative retention times.]

Suitability requirements

Resolution: NLT 1.5 between pancuronium related compound B and pancuronium related compound A; NLT 1.5 between pancuronium related compound C and vecuronium peaks, System suitability solution

Tailing factor: NMT 2.0, Standard solution

Relative standard deviation: NMT 10.0%, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of each impurity as well as any unspecified impurity in the portion of Injection taken:

Result = (r_U/r_S) x (C_S/C_U) x 100

r_U = peak response of each impurity from the Sample solution

r_S = peak response of the pancuronium peak from the Standard solution

C_S = concentration of USP Pancuronium Bromide RS in the Standard solution (mg/mL)

C_U = nominal concentration of pancuronium bromide in the Sample solution (mg/mL)

Acceptance criteria: See Table 1.

Table 1

^a Piperidinium, 1-[(2,3,5,16,17)-17-acetyloxy-3-hydroxy-2-(1-piperidinyl)androstan-16-yl]-1-methyl. This impurity is the acid degradation product of vecuronium bromide and may be present only in the System suitability solution.

^b This process impurity is included for peak identification purposes only and is controlled in the drug substance. This is not included in the total impurities.

5 SPECIFIC TESTS

5.1 PH (791)

3.8-4.2

5.2 PARTICULATE MATTER IN INJECTIONS (788)

It meets the requirements for small-volume injections.

5.3 BACTERIAL ENDOTOXINS TEST (85)

It contains NMT 50 USP Endotoxin Units/mg of pancuronium bromide.

5.4 INJECTIONS AND IMPLANTED DRUG PRODUCTS (1)

Meets the requirements

6 ADDITIONAL REQUIREMENTS

6.1 PACKAGING AND STORAGE

Preserve in tight, single-dose or multiple-dose containers for injections, as described in Packaging and Storage Requirements (659), Injection Packaging, preferably of Type 1 glass. Store in a refrigerator between 2° and 8°, protected from light.

6.2 USP REFERENCE STANDARDS (11)

USP Pancuronium Bromide RS

USP Pancuronium Bromide Related Compound A RS

1,1'-(3α,17β-Dihydroxy-5α-androstan-2β,16β-ylene)bis(1-methylpiperidinium) dibromide.

C₃₁H₅₆Br₂N₂O₂ 648.60

USP Pancuronium Bromide Related Compound B RS

1,1'-(17β-Acetoxy-3α-hydroxy-5α-androstan-2β,16β-ylene)bis(1-methylpiperidinium) dibromide.

C₃₃H₅₈Br₂N₂O₃ 690.63

USP Pancuronium Bromide Related Compound C RS

1,1'-(3α-Acetoxy-17β-hydroxy-5α-androstan-2β,16β-ylene)bis(1-methylpiperidinium) dibromide.

C₃₃H₅₈Br₂N₂O₃ 690.63

USP Vecuronium Bromide RS