Prednisolone Compounded Oral Suspension, Veterinary
DEFINITION
Prednisolone Compounded Oral Suspension, Veterinary contains NLT 90.0% and NMT 110.0% of the labeled amount of prednisolone (C21H28O5).
Prepare Prednisolone Compounded Oral Suspension, Veterinary, 20 mg/mL, as follows (see Pharmaceutical Compounding—Nonsterile Preparations 
795
).
795).| Prednisolone powder | 2 g |
| Purified Water | a small amount |
| Syrup, NF, a sufficient quantity to make | 100 mL |
Pour the weighed Prednisolone powder into a suitable mortar. Wet the powder with a small amount of Purified Water, and triturate to make a smooth paste. Add the Syrup 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 Syrup to bring the preparation to final volume. Shake to mix well.
ASSAY
• Procedure
Mobile phase:
Acetonitrile and water (30:70). Filter, and degas.
System suitability solution:
1 mg/mL of USP Prednisolone RS and 0.06 mg/mL of USP Hydrocortisone RS in Mobile phase
Standard solution:
0.2 mg/mL of prednisolone prepared from USP Prednisolone RS in Mobile phase
Sample solution:
Shake thoroughly each bottle of Oral Suspension, Veterinary. Transfer 1.0 mL of the Oral Suspension, Veterinary into a 100-mL volumetric flask, and dilute with Mobile phase to volume to obtain a solution having a nominal concentration of 0.2 mg/mL of prednisolone.
Chromatographic system
Mode:
LC
Detector:
UV 246 nm
Column:
4.6-mm × 15-cm; 3-µm packing L1
Column temperature:
40
Flow rate:
1.0 mL/min
Injection volume:
10 µL
System suitability
Samples:
System suitability solution and Standard solution
[Note—The relative retention times for prednisolone and hydrocortisone are about 1.0 and 1.06, respectively. ]
Suitability requirements
Resolution:
NLT 2.0 between prednisolone and hydrocortisone, System suitability solution
Tailing factor:
NMT 2.0, Standard solution
Relative standard deviation:
NMT 2.0%, Standard solution
Peak-to-valley ratio:
The ratio of the height of the smallest peak to the height of the valley between the prednisolone and hydrocortisone peak is NLT 2, System suitability solution
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of the labeled amount of prednisolone (C21H28O5) in the portion of Oral Suspension, Veterinary taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response of prednisolone from the Sample solution |
| rS | = | = peak response of prednisolone from the Standard solution |
| CS | = | = concentration of prednisolone in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of prednisolone in the Sample solution (mg/mL) |
Acceptance criteria:
90.0%–110.0%
SPECIFIC TESTS
• pH 791:
2.6–3.6
791:
2.6–3.6
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. Label it to state that it is for veterinary use only.
• Beyond-Use Date:
NMT 90 days after the date on which it was compounded when stored at 2–8 or at controlled room temperature
–8 or at controlled room temperature
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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 4980
Pharmacopeial Forum: Volume No. 39(4)