Hydrocortisone Hydrocortisone 50-23-7
COS, DMF, GMP
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Raw materials from chinese origin
Hefei TNJ Chemical Industry Co., limited(ISO 9001: 2008), are strong in the field of Pharmaceuticals,
food additives, plant extract and fine chemicals for more than 10 years.
1.Product description
Product Name: Hydrocortisone
CAS: 50-23-7
MF: C21H30O5
MW: 362.46
EINECS: 200-020-1
2.Physical properties
White or almost white crystalline powder; odorless.
Tasteless early, followed by continued bitterness; perishable when it meets light.. Insoluble in water. Its acetate as a white or almost white crystalline powder; no foul.
mp 211-214 °C(lit.)
alpha 166 º (c=1, C2H5OH 25 ºC)
Fp 220°C
storage temp. −20°C
solubility H2O: 100 mg/mL
form powder
Decomposition 220 ºC
Merck 14,4787
BRN 1354819
Stability: Stable, but may be light sensitive. Incompatible with strong oxidizing agents.
3.Specification
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 |
ITEMS |
SPECIFICATION |
RESULTS |
CHLOROFORM |
NOT MORE THAN 60PPM |
NOT DETECT OUT |
PARTICLE SIZE(IN-HOUSE) |
90% NOT MORE THAN 15 MICRONS |
COMPLIES |
CONCLUSION:THE PRODUCT CONFORMS TO PH.EUR.6/USP34 |
4.Application
1). For adrenal insufficiency caused by disease, rheumatoid arthritis, rheumatic fever, gout, bronchial asthma. For atopic dermatitis, seborrheic dermatitis, pruritus. Large doses cause Cushing's syndrome, sodium retention, psychiatric symptoms, digestive ulcers, osteoporosis, growth inhibition.
2). For iridocyclitis, keratitis, scleritis, conjunctivitis. For neurodermatitis, for tuberculous meningitis, pleurisy, arthritis, tenosynovitis, acute and chronic sprain, strain, etc. sheath.
5.Packing
25KG/Drum or as per your requirement
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