Alprazolam 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)

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1 DEFINITION

Alprazolam Compounded Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of alprazolam (C₁₇H₁₃CIN₄).

Prepare Alprazolam Compounded Oral Suspension 1 mg/mL as follows (see Pharmaceutical Compounding-Nonsterile Preparations (795)).

Comminute tablets in a suitable mortar to a fine powder, or add Alprazolam powder. Add about 20 mL of the Vehicle, and mix to a uniform paste. Add the Vehicle in small portions almost to volume, and mix thoroughly after each addition. Transfer the contents of the mortar, stepwise and quantitatively, to a calibrated bottle. Add sufficient Vehicle to bring to final volume, and mix well.

2 ASSAY

2.1 PROCEDURE

Buffer: 0.04 M sodium acetate solution. Adjust with glacial acetic acid to a pH of 2.4.

Mobile phase: Methanol, acetonitrile, and Buffer (45:8:47)

Standard solution: 20 µg/mL of USP Alprazolam RS in Mobile phase

Sample solution: Agitate the container of Oral Suspension for 30 min on a rotating mixer, remove a 5-mL sample, and store in a clear glass vial at -70° until analyzed. At the time of analysis, remove the sample from the freezer, allow it to reach room temperature, and mix with a vortex mixer for 30 s. Dilute a suitable volume of the Oral Suspension in in Mobile phase to obtain a nominal concentration of 20 µg/mL.

2.2 Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 230 nm

OFFICIAL

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

Flow rate: 0.6 mL/min

Injection volume: 20 µL

2.3 System suitability

Sample: Standard solution

[NOTE-The retention time min.]

Suitability requirements

Relative standard deviation: NMT 1.4% for replicate injections

2.4 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of alprazolam (C₁₇H₁₃CIN₄) 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 Alprazolam RS in the Standard solution (µg/mL)

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

Acceptance criteria: 90.0%-110.0%

3 SPECIFIC TESTS

PH (791): 4.0-5.0

4 ADDITIONAL REQUIREMENTS

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

BEYOND-USE DATE: NMT 60 days after the day on which it was compounded when stored at controlled room temperature or in a refrigerator

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

USP REFERENCE STANDARDS (11)

USP Alprazolam RS