Hydrocortisone Acetate
USP35
C23H32O6 404.50
Pregn-4-ene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-, (11
)-;
Cortisol 21-acetate
[50-03-3].
781S
(hye'' droe kor' ti sone as' e tate).
Change to read:
+'&img=../../images/v35300/cas-50-03-3.gif&casNumber=50-03-3&usp=35&nf=30&chemicalStructureImage=true&ID='+parent.myID,600,500);)
USP35C23H32O6 404.50
Pregn-4-ene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-, (11
)-;
Cortisol 21-acetate
[50-03-3].DEFINITION
Hydrocortisone Acetate contains NLT 97.0% and NMT 102.0% of C23H32O6, calculated on the dried basis.
IDENTIFICATION
• B. Ultraviolet Absorption 197U
197U
Sample solution:
10 µg/mL in methanol
Analytical wavelength:
242 nm
Acceptance criteria:
Absorptivities, calculated on the dried basis, do not differ by more than 2.5%.
ASSAY
• Procedure
Mobile phase:
Butyl chloride, water-saturated butyl chloride, tetrahydrofuran, methanol, and glacial acetic acid (475:475:70:35:30)
Standard solution:
0.10 mg/mL of USP Hydrocortisone Acetate RS in Mobile phase
Sample solution:
0.10 mg/mL of Hydrocortisone Acetate in Mobile phase
Chromatographic system
Mode:
LC
Detector:
UV 254 nm
Column:
4-mm × 30-cm; 10-µm packing L3
Flow rate:
1 mL/min
Injection size:
10 µL
System suitability
Sample:
Standard solution
Suitability requirements
Tailing factor:
NMT 2.0
Relative standard deviation:
NMT 2.0%
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of hydrocortisone acetate (C23H32O6) in the portion of Hydrocortisone Acetate taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response of hydrocortisone acetate from the Sample solution |
| rS | = | = peak response of hydrocortisone acetate from the Standard solution |
| CS | = | = concentration of USP Hydrocortisone Acetate RS in the Standard solution (mg/mL) |
| CU | = | = concentration of Hydrocortisone Acetate in the Sample solution (mg/mL) |
Acceptance criteria:
97.0%–102.0% on the dried basis
IMPURITIES
Inorganic Impurities
Organic Impurities
• Procedure
Solution A:
Acetonitrile and water (20:80)
Solution B:
Acetonitrile and water (70:30)
Mobile phase:
See Table 1.
Table 1
| Time (min) |
Solution A (%) |
Solution B (%) |
|---|---|---|
| 0 | 90 | 10 |
| 5 | 90 | 10 |
| 25 | 10 | 90 |
| 30 | 10 | 90 |
| 35 | 90 | 10 |
| 40 | 90 | 10 |
Diluent:
Acetonitrile, glacial acetic acid, and water (700:1:300)
Standard solution:
5 µg/mL of USP Hydrocortisone Acetate RS in Diluent
Sample solution:
1 mg/mL of Hydrocortisone Acetate in Diluent
Chromatographic system
Mode:
LC
Detector:
UV 254 nm
Column:
4.6-mm × 15-cm; 3-µm packing L1
Flow rate:
1 mL/min
Injection size:
10 µL
System suitability
Sample:
Standard solution
Suitability requirements
Relative standard deviation:
NMT 5.0%
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of each impurity in the portion of Hydrocortisone Acetate taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response of each impurity from the Sample solution |
| rS | = | = peak response from the Standard solution |
| CS | = | = concentration of USP Hydrocortisone Acetate RS in the Standard solution (mg/mL) |
| CU | = | = concentration of Hydrocortisone Acetate in the Sample solution (mg/mL) |
Acceptance criteria
Individual impurities:
NMT 1.0%
Total impurities:
NMT 2.0%
SPECIFIC TESTS
Change to read:
• Optical Rotation, Specific Rotation 781S
Sample solution:
10 mg/mLUSP35 in dioxane
10 mg/mLUSP35 in dioxane
Acceptance criteria:
Between +158
and +167 at 20USP35
and +167 at 20USP35
• Loss on Drying 731:
Dry a sample in vacuum at 60 for 3 h: it loses NMT 1.0% of its weight.
731:
Dry a sample in vacuum at 60 for 3 h: it loses NMT 1.0% of its weight.
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in well-closed containers.
• USP Reference Standards 11
11
USP Hydrocortisone Acetate RS 
Preg-4-ene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-, (11)-.
C23H32O6 404.50
') + '&img=../../images/v35300/cas-50-03-3.gif',600,500);)
Preg-4-ene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-, (11
)-.
C23H32O6 404.50
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Domenick Vicchio, Ph.D.
Senior Scientific Liaison 1-301-998-6828 |
(SM42010) Monographs - Small Molecules 4 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 3434
Pharmacopeial Forum: Volume No. 36(6) Page 1533