High quality Hydrocortisone 50-23-7
Appearance: white fine powder
specification: 99%
MF: C21H30O5
MW:362.46
High quality Hydrocortisone 50-23-7
Appearance: white fine powder
specification: 99%
MF: C21H30O5
MW:362.46
Standard: BP, USP ,EP
Packing: 25kg/drum
Function
Hydrocortisone is a natural corticosteroid produced by the adrenal glands located adjacent to the kidneys.
Corticosteroids have potent antiinflammatory propeties,
and are used in a wide variety of inflammatory conditions such as arthritis, colitis, asthma, bronchitis, certain skin rashes,
and allergic or inflammatory conditions
COA
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ITEMS |
SPECIFICATION EP6/USP32 |
RESULTS |
|
CHARACTERS(PH.EUR.) |
A WHITE OR ALMOST WHITE,CRYSTALLINE POWDER |
WHITE CRYSTALLINE POWDER |
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SOLUBILITY(PH.EUR.) |
PRACTICALLY INSOLUBLE IN WATER,SPARINGLY SOLUBLE IN ACETONE AND IN ALCOHOL,SLIGHTLY IN METHYLENE CHLORIDE |
COMPLIES |
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IDENTIFICATION |
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A.IR-SPECTRUM(PH.EUR) |
MEETS THE REQUIREMENT |
COMPLIES |
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B.TLC(PH.EUR) |
MEETS THE REQUIREMENT |
COMPLIES |
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A.IR-SPECTRUM(USP) |
MEETS THE REQUIREMENT |
COMPLIES |
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B.UV ABSORPTION(USP) |
MEETS THE REQUIREMENT |
COMPLIES |
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SPECIFIC OPTICAL ROTATION |
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(PH.EUR) |
BETWEEN+150°AND +156° |
+152.6° |
|
(USP) |
BETWEEN+150°AND +156° |
+152.6° |
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LOSS ON DRYING |
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|
(PH.EUR) |
NOT MORE THAN 1.0% |
0.06% |
|
(USP) |
NOT MORE THAN 1.0% |
0.09% |
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RESIDUE ON IGNITION(USP) |
NEGLIGIBLE,FROM 100MG |
COMPLIES |
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RELATED SUBSTANCES(PH.EUR) |
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ANY INDIVIDUAL IMPURITY |
NOT MORE THAN 0.5% |
0.23% |
|
SUM OF IMPURITIES |
NOT MORE THAN 1.5% |
1.00% |
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CHROMATOGRAPHIC PURITY(USP) |
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ANY INDIVIDUAL IMPURITY |
NOT MORE THAN 0.5% |
0.20% |
|
SUM OF IMPURITIES |
NOT MORE THAN 2.0% |
1.06% |
|
ASSAY |
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|
UV ABSORPTION(PH.EUR.) |
BETWEEN 97.0% AND 103.0% |
100.4% |
|
HPLC(USP) |
BETWEEN 97.0% AND 102.0% |
99.9% |
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RESIDUAL SOLVENT(IN-HOUSE) |
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METHANOL |
NOT MORE THAN 500PPM |
NOT DETECT OUT |
|
ETHANOL |
NOT MORE THAN 2000PPM |
243PPM |
|
METHYLENE CHLORIDE |
NOT MORE THAN 600PPM |
NOT DETECT OUT |
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ITEMS |
SPECIFICATION |
RESULTS |
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CHLOROFORM |
NOT MORE THAN 60PPM |
NOT DETECT OUT |
|
PARTICLE SIZE(IN-HOUSE) |
90% NOT MORE THAN 15 MICRONS |
COMPLIES |
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CONCLUSION:THE PRODUCT CONFORMS TO PH.EUR.6/USP34 |
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