Amiodarone Hydrochloride Compounded Oral Suspension

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

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

DOWNLOAD PDF HERE

1 DEFINITION

Amiodarone Hydrochloride Compounded Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of amiodarone hydrochloride (C₂₅H₂₉I₂NO₃·HCI).

Prepare Amiodarone Hydrochloride Compounded Oral Suspension 5 mg/mL as follows (see Pharmaceutical Compounding-Nonsterile Preparations (795)).

^a Cordarone 200-mg tablets, Wyeth-Ayerst Laboratories, Philadelphia, PA.

^b Paddock Laboratories, Minneapolis, MN.

Calculate the required quantity of each ingredient for the total amount to be prepared. Place the required number of Amiodarone Hydrochloride tablets in a suitable mortar and comminute to a fine powder with a pestle. Adjust the pH of the Vehicle to 6.5 ± 0.5 with a sodium bicarbonate 50-mg/mL solution prepared in Purified Water. Add the Vehicle in small portions and triturate to make a smooth paste. Add increasing volumes of the Vehicle to make an amiodarone hydrochloride liquid that is pourable. Transfer the contents of the mortar, stepwise and quantitatively, to a calibrated bottle. Add enough of the Vehicle to bring to final volume and mix well.

2 ASSAY

2.1 PROCEDURE

Mobile phase: Methanol, water, and 50 mM monobasic ammonium phosphate (0.5:0.5:99)

Standard solution: 2.5 mg/mL of USP Amiodarone Hydrochloride RS in Mobile phase

Sample solution: Shake thoroughly by hand each bottle of the Oral Suspension. Prepare 2.5 mg/mL of amiodarone hydrochloride from Oral Suspension and Mobile phase.

2.2 Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 230 nm

Column: 4.6-mm × 25-cm; 10-µm packing L1

Flow rate: 1.5 mL/min

Injection volume: 10 µL

2.3 System suitability

Sample: Standard solution

[NOTE-The retention time for amiodarone is about 3.6 min.]

Suitability requirements

Relative standard deviation: NMT 2.1% for replicate injections

2.4 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of amiodarone hydrochloride (C₂₅H₂₉I₂NO₃·HCI) in the portion of Oral Suspension 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 Amiodarone Hydrochloride RS in the Standard solution (mg/mL)

C_U = nominal concentration of amiodarone hydrochloride in the Sample solution (mg/mL)

Acceptance criteria: 90.0%-110.0%

3 SPECIFIC TESTS

PH (791): 5.8-6.8

4 ADDITIONAL REQUIREMENTS

4.1 PACKAGING AND STORAGE

Package in tight, light-resistant containers. Store in a refrigerator or at controlled room temperature.

4.2 BEYOND-USE DATE

NMT 90 days after the date on which it was compounded when stored in a refrigerator; NMT 30 days when stored at controlled room temperature

4.3 LABELING

Label it to state that it is to be well shaken before use and to state the Beyond-Use Date.

4.4 USP REFERENCE STANDARDS (11)

USP Amiodarone Hydrochloride RS