Alprazolam Oral Suspension
DEFINITION
Alprazolam Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of alprazolam (C17H13ClN4).
Prepare Alprazolam Oral Suspension 1 mg/mL as follows (see Pharmaceutical Compounding—Nonsterile Solutions 
795
).
795).| Alprazolam | 100 mg |
| Vehicle: a mixture of Vehicle for Oral Solution (regular or sugar-free), NF, and Vehicle for Oral Suspension, NF (1:1), a sufficient quantity to make | 100 mL |
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.
ASSAY
• 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 Mobile phase to obtain a nominal concentration of 20 µg/mL.
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 Mobile phase to obtain a nominal concentration of 20 µg/mL.
Chromatographic system
Mode:
LC
Detector:
UV 230 nm
Column:
4.6-mm × 25-cm; 5-µm packing L1
Flow rate:
0.6 mL/min
Injection size:
20 µL
System suitability
Sample:
Standard solution
[Note—The retention time of alprazolam is about 10 min. ]
Suitability requirements
Relative standard deviation:
NMT 1.4% for replicate injections
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of the labeled amount of alprazolam (C17H13ClN4) in the portion of Oral Suspension taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response from the Sample solution |
| rS | = | = peak response from the Standard solution |
| CS | = | = concentration of alprazolam in the Standard solution (µg/mL) |
| CU | = | = nominal concentration of alprazolam in the Sample solution (µg/mL) |
Acceptance criteria:
90.0%–110.0%
SPECIFIC TESTS
• pH 791:
4.0–5.0
791:
4.0–5.0
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Package in tight, light-resistant containers. Store at controlled room temperature, or under refrigeration.
• Labeling:
Label it to state that it is to be well-shaken before use, and to state the Beyond-Use Date.
Beyond-Use Date:
NMT 60 days after the day on which it was compounded
• USP Reference Standards 11
11
USP Alprazolam RS 
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Jeanne H. Sun
Assistant Scientific Liaison 1-301-816-3361 |
(CMP2010) Compounding |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 2103
Pharmacopeial Forum: Volume No. 32(1) Page 46