Prednisolone Sodium Phosphate Compounded Oral Solution
DEFINITION
Prednisolone Sodium Phosphate Compounded Oral Solution contains NLT 90.0% and NMT 110.0% of the labeled amount of prednisolone (C21H28O5). Prepare Prednisolone Sodium Phosphate Compounded Oral Solution 10 mg/mL as follows (see Pharmaceutical Compounding—Nonsterile Preparations 
795
).
795).Pour the weighed Prednisolone Sodium Phosphate Powder into a suitable container. Wet the powder with a small amount of Purified Water, and triturate to make a smooth paste. Add the Vehicle to make the contents pourable. Transfer the contents, stepwise and quantitatively, to a calibrated container. Add sufficient Vehicle to bring to final volume. Shake to mix well.
ASSAY
• Procedure
Solution A:
Dissolve 2.0 g of 1-pentanesulfonic acid sodium in 1000 mL of water.
Solution B:
Mix 980 mL of Solution A with 20 mL of tetrahydrofuran. Adjust with phosphoric acid to a pH of 2.0.
Mobile phase:
Methanol and Solution B (45:55)
Standard solution:
0.4 mg/mL of prednisolone prepared from USP Prednisolone Sodium Phosphate RS in Solution B
Sample solution:
Shake each bottle of Oral Solution thoroughly. Transfer 1.0 mL of Oral Solution to a 25-mL volumetric flask, dilute with Solution B to volume, and mix well.
Chromatographic system
Mode:
LC
Detector:
UV 246 nm
Column:
4.6-mm × 25-cm; 5-µm packing L1
Flow rate:
1.0 mL/min
Injection volume:
10 µL
System suitability
Sample:
Standard solution
[Note—The retention time for prednisolone is about 11.3 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 prednisolone (C21H28O5) in the portion of Oral Solution 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:
3.9–4.9
791:
3.9–4.9
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 at controlled room temperature
–8 or at controlled room temperature
• USP Reference Standards 11
11
USP Prednisolone Sodium Phosphate 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 4983
Pharmacopeial Forum: Volume No. 39(5)