Hydrocortisone

CAS No. 50-23-7
Other Names Hydrocortisone Base
MF C21H30O5
EINECS No. 200-020-1
Place of Origin Zhejiang, China (Mainland)
Type Antibiotic and Antimicrobial Agents, Immune Function Agents
Grade Standard Medicine Grade

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Hydrocortisone Details

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ITEMS	SPECIFICATION EP6/USP32	RESULTS
CHARACTERS(PH.EUR.)	A WHITE OR ALMOST WHITE,CRYSTALLINE POWDER	WHITE CRYSTALLINE POWDER
SOLUBILITY(PH.EUR.)	PRACTICALLY INSOLUBLE IN WATER,SPARINGLY SOLUBLE IN ACETONE AND IN ALCOHOL,SLIGHTLY IN METHYLENE CHLORIDE	COMPLIES
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 OPTICAL ROTATION
(PH.EUR)	BETWEEN+150°AND +156°	+152.1°
(USP)	BETWEEN+150°AND +156°	+153.3°
LOSS ON DRYING
(PH.EUR)	NOT MORE THAN 1.0%	0.04%
(USP)	NOT MORE THAN 1.0%	0.05%
RESIDUE ON IGNITION(USP)	NEGLIGIBLE,FROM 100MG	COMPLIES
RELATED SUBSTANCES(PH.EUR)
ANY INDIVIDUAL IMPURITY	NOT MORE THAN 0.5%	0.30%
SUM OF IMPURITIES	NOT MORE THAN 1.5%	1.24%
CHROMATOGRAPHIC PURITY(USP)
ANY INDIVIDUAL IMPURITY	NOT MORE THAN 0.5%	0.28%
SUM OF IMPURITIES	NOT MORE THAN 2.0%	1.25%
ASSAY
UV ABSORPTION(PH.EUR.)	BETWEEN 97.0% AND 103.0%	100.70%
HPLC(USP)	BETWEEN 97.0% AND 102.0%	98.70%
RESIDUAL SOLVENT(IN-HOUSE)
METHANOL	NOT MORE THAN 500PPM	NOT DETECT OUT
ETHANOL	NOT MORE THAN 2000PPM	455PPM
METHYLENE CHLORIDE	NOT MORE THAN 600PPM	NOT DETECT OUT
CONCLUSION:THE PRODUCT CONFORMS TO PH.EUR.6/USP34

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