HYDROCORTISONE ACETATE HYDROCORTISONE ACETATE HYDROCORTISONE ACETATE
1. GMP AVALIABLE ;
2. IN STOCK
3. FAST REPLY
QUALIFED ; EFFICIENCY; RESPONSIBLE
ITEMS |
SPECIFICATION |
RESULTS |
Appearance |
White to practically white,odorless,crystalline powder |
White crystalline powder |
Solubility |
Slightly soluble in alcohol and in chloroform; insoluble in water |
Complies |
Identification |
A.IR spectrum : Infrared absorption |
Complies |
B.UV Absorption:Absorptivities, calculated on the dried basis, do not differ by more than 2.5% |
Complies |
|
Specific rotation |
between+158°and +167° |
+163.7° |
Loss on drying |
not more than 1.0% |
0.03% |
Residue on ignition |
not more than 0.5% |
0.00% |
Organic impurities |
Individual impurities not more than 1.0% |
0.14% |
Total impurities not more than 2.0% |
0.42% |
|
Assay |
between 97.0% and 102.0% |
99.5% |
Residual solvent(In-house) |
Methanol NMT3000ppm |
5ppm |
Ethanol NMT2000ppm |
256ppm |
|
Acetone NMT5000ppm |
ND |
|
Methylene chloride NMT600ppm |
ND |
|
DMF NMT880ppm |
ND |
|
Particle size (in house) |
90% not more than 20 microns |
Complies |
Conclusion: The product complies with USP42 |
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