Piroxicam Compounded Oral Suspension
DEFINITION
Piroxicam Compounded Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of piroxicam (C15H13N3O4S).
Prepare Piroxicam Compounded Oral Suspension 10 mg/mL as follows (see Pharmaceutical Compounding—Nonsterile Preparations 
795
.
795. | Piroxicam powder | 1 g |
| Ora-Blend,a a sufficient quantity to make | 100 mL |
|
a
Perrigo, Minneapolis, MN.
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|
Pour the weighed Piroxicam powder into a suitable mortar. Wet the powder with a small amount of Ora-Blend, and triturate to make a smooth paste. Add the Ora-Blend in small portions almost to volume, and mix thoroughly after each addition. Transfer the contents of the mortar, stepwise and quantitatively, to a calibrated container. Add sufficient Ora-Blend to bring the preparation to final volume. Shake to mix well.
ASSAY
• Procedure
Mobile phase:
Mix 500 mL of methanol and 500 mL of 0.1 M sodium acetate, and adjust with phosphoric acid to a pH of 4.0. Add 10 mL of acetonitrile, filter, and degas.
Standard solution:
0.2 mg/mL of piroxicam prepared from USP Piroxicam RS in methanol
Sample solution:
Shake thoroughly each bottle of Oral Suspension. Transfer 1.0 mL of the Oral Suspension into a 50-mL volumetric flask, dilute with methanol to volume, and mix well to dissolve. Pass through a PVDF filter of 0.45-µm pore size, discarding the first 3 mL of filtrate.
Chromatographic system
Mode:
LC
Detector:
UV 361 nm
Column:
3.9-mm × 15-cm; 4-µm packing L7
Flow rate:
1.0 mL/min
Injection volume:
5 µL
System suitability
Sample:
Standard solution
[Note—The retention time for piroxicam is about 4.0 min. ]
Suitability requirements
Tailing factor:
NMT 2.0
Relative standard deviation:
NMT 2.0% for replicate injections
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of the labeled amount of piroxicam (C15H13N3O4S) in the portion of Oral Suspension taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response of piroxicam from the Sample solution |
| rS | = | = peak response of piroxicam from the Standard solution |
| CS | = | = concentration of piroxicam in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of piroxicam in the Sample solution (mg/mL) |
Acceptance criteria:
90.0%–110.0%
SPECIFIC TESTS
• pH 791:
3.7–4.7
791:
3.7–4.7
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Package in tight, light-resistant containers. Store at 2
–8 or at controlled room temperature.
–8 or at controlled room temperature.
• Labeling:
Label it to indicate that it is to be well-shaken before use, and to state the Beyond-Use Date.
• Beyond-Use Date:
NMT 90 days after the date on which it was compounded when stored at 2–8 or controlled room temperature
–8 or controlled room temperature
• USP Reference Standards 11
11
USP Piroxicam 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, Pharm.D.
Associate Scientific Liaison (301) 230-3361 |
(CMP2010) Compounding |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP38–NF33 Page 4913
Pharmacopeial Forum: Volume No. 39(4)