Hydrocortisone acetate Hydrocortisone acetate high purity Cortisol acetate
1.Hydrocortisone acetate
2.CAS:50-03-3
3.EP7 GMP DMF COS
4.Appearance:A white or almost white crystalline powder
5.Certificate of analysis:
ITEMS |
SPECIFICATION |
RESULTS |
CHARACTERS |
A WHITE OR ALMOST WHITE, CRYSTALLINE POWDER |
WHITE CRYSTALLINE POWDER |
SOLUBILITY |
PRACTICALLY INSOLUBLE IN WATER, SPARINGLY SOLUBLE IN ETHANOL AND IN METHYLENE CHLORIDE |
COMPLIES |
MELTING POINT(PH.EUR.) |
ABOUT 220°C |
223°C |
IDENTIFICATION |
||
A.IR-SPECTRUM(PH.EUR) |
MEETS THE REQUIREMENT |
COMPLIES |
B.TLC(PH.EUR) |
MEETS THE REQUIREMENT |
COMPLIES |
A.IR-SPECTRUM(USP) |
MEETS THE REQUIREMENT |
COMPLIES |
B.UV ABSORPTION(USP) |
MEETS THE REQUIREMENT |
COMPLIES |
SPECIFIC ROTATION |
||
(PH.EUR) |
BETWEEN+158°AND +167° |
+164.7° |
(USP) |
BETWEEN+158°AND +165° |
+160.3° |
LOSS ON DRYING |
||
(PH.EUR) |
NOT MORE THAN 0.5% |
0.21% |
(USP) |
NOT MORE THAN 1.0% |
0.16% |
RESIDUE ON IGNITION(USP) |
NEGLIGIBLE,FROM 100mg |
COMPLIES |
RELATED SUBSTANCES(PH.EUR) |
||
ANY INDIVIDUAL IMPURITY |
NOT MORE THAN 1.0% |
0.16% |
SUM OF IMPURITIES |
NOT MORE THAN 1.5% |
0.55% |
CHROMATOGRAPHIC PURITY(USP) |
||
ANY INDIVIDUAL IMPURITY |
NOT MORE THAN 1.0% |
0.12% |
SUM OF IMPURITIES |
NOT MORE THAN 2.0% |
0.64% |
RESIDUAL SOLVENT(IN-HOUSE) |
||
ETHANOL |
NOT MORE THAN 2000PPM |
817PPM |
DMF |
NOT MORE THAN 880PPM |
N.D. |
ASSAY |
||
(PH.EUR) |
BETWEEN 97.0% AND 103.0% |
100.6% |
(USP) |
BETWEEN 97.0% AND 102.0% |
100.6% |
PARTICLE SIZE(IN-HOUSE) |
90% NOT MORE THAN 20 MICRONS |
COMPLIES |
CONCLUSION:THE PRODUCT CONFORMS TO PH.EP.6 |
6.USE:
It is mainly used to treat rheumatoid arthritis, rheumatic fever, gout, bronchial asthma. Injection for tuberculous or fester sex meningitis, tuberculosis pleurisy, pyothorax, arthritis, tenosynovitis, tendons strain, sprains, nodular rash, itching flat moss, etc. Eye drops agent used in all kinds of eye inflammation. Frost agent in allergic or seborrheic dermatitis, itch disease, etc.
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