Prednisone
Pregna-1,4-diene-3,11,20-trione,
17,21-Dihydroxypregna-1,4-diene-3,11,20-trione
[53-03-2].
(pred' ni sone).
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USP38
Pregna-1,4-diene-3,11,20-trione,
USP38
17,21-Dihydroxypregna-1,4-diene-3,11,20-trione
USP38
[53-03-2].DEFINITION
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USP38
IDENTIFICATION
• A. Infrared Absorption 
197K
197K
Analysis:
If a difference appears, dissolve portions of both the sample and the Reference Standard in methanol, evaporate the solutions to dryness, and repeat the tests.
Acceptance criteria:
Meets the requirements
• B.
Analysis 1:
Dissolve 6 mg in 2 mL of sulfuric acid, and allow to stand for 5 min.
Acceptance criteria 1:
An orange color is produced.
Analysis 2:
Pour the resulting solution from Analysis 1 into 10 mL of water.
Acceptance criteria 2:
The color changes first to yellow and then, gradually, to bluish green.
ASSAY
• Procedure
Mobile phase:
Peroxide-free tetrahydrofuran, methanol, and water (250:62:688)
Diluent:
Methanol and water (1:1)
Standard stock solution:
0.2 mg/mL of USP Prednisone RS in Diluent
Internal standard solution:
110 µg/mL of acetanilide in Diluent
Standard solution:
20 µg/mL of USP Prednisone RS and 11 µg/mL of acetanilide in Diluent from the Standard stock solution and the Internal standard solution, respectively. Prepare this solution fresh.
Sample stock solution:
0.2 mg/mL of Prednisone in Diluent
Sample solution:
20 µg/mL of Prednisone and 11 µg/mL of acetanilide in Diluent from the Sample stock solution and the Internal standard solution, respectively. Prepare this solution fresh.
Chromatographic system
Mode:
LC
Detector:
UV 254 nm
Column:
4-mm × 25-cm; packing L1
Flow rate:
1.0 mL/min
Injection volume:
10 µL
System suitability
Sample:
Standard solution
[Note—The retention times of acetanilide and prednisone are about 6 and 8 min, respectively. ]
Suitability requirements
Resolution:
NLT 3 between prednisone and acetanilide
Relative standard deviation:
NMT 2.0%
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of prednisone (C21H26O5) in the portion of Prednisone taken:
Result = (RU/RS) × (CS/CU) × 100
| RU | = | = peak response ratio of prednisone to acetanilide from the Sample solution |
| RS | = | = peak response ratio of prednisone to acetanilide from the Standard solution |
| CS | = | = concentration of USP Prednisone RS in the Standard solution (µg/mL) |
| CU | = | = concentration of Prednisone in the Sample solution (µg/mL) |
Acceptance criteria:
97.0%–102.0% on the anhydrous basis
IMPURITIES
• Organic Impurities
Mobile phase:
Chloroform and methanol (98:2)
Sample solution:
1.25 mg/mL of Prednisone in Mobile phase
Chromatographic system
Mode:
LC
Detector:
UV 254 nm
Column:
6.0-mm × 4.0-cm; packing L3
Flow rate:
1 mL/min
Injection volume:
5 µL
System suitability
Sample:
Sample solution
Suitability requirements
Column efficiency:
NLT 2500 theoretical plates
Relative standard deviation:
NMT 2.0%
Analysis
Sample:
Sample solution
Calculate the percentage of each impurity in the portion of Prednisone taken:
Result = (rU/rT) × 100
| rU | = | = peak response for each impurity |
| rT | = | = sum of all the peak responses |
Acceptance criteria
Any individual impurity:
NMT 1.5%
Total impurities:
NMT 2.0%
SPECIFIC TESTS
• Optical Rotation, Specific Rotation 781S
781S
Sample solution:
5 mg/mL in dioxane
Acceptance criteria:
+167
to +175
to +175
ADDITIONAL REQUIREMENTS
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• Packaging and Storage:
Preserve in well-closed containers,
USP38
Delete the following:
• USP38
• USP Reference Standards 11
11
USP Prednisone RS 
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Mary P. Koleck, Ph.D.
Scientific Liaison (301) 230-7420 |
(SM42010) Monographs - Small Molecules 4 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP38–NF33 Page 4986
Pharmacopeial Forum: Volume No. 39(6)