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喜樹堿 黃體酮 噻菌靈/噻苯咪唑 硫酸新霉素 紅霉素
Product Name:
Hydrocortisone Acetate
Batch No.:
20220727
Manuf. Date:
Quantity:
550kg
Retest Date:
2025.07.27
Package:
Drum or carton
Report Date:
Items
Requirements
Results
Appearance
a white or almost white,crystalline powder
White crystalline powder
Solubility
Practically insoluble in water,slightly soluble in anhydrous ethanol and in methylene chloride
Complies
Melting point(Ph.Eur.） about220℃ 222℃
A.IR -spectrum（Ph.Eur.）
meets the requirement
B.TLC（Ph.Eur.）
A.IR-spectrum（USP）
B.UV Absorption（USP）
Specific optical rotation
（Ph.Eur.）
between +158°and+167°
+163.0°
（USP）
between +158°and+165°
+162.9°
Loss on drying
not more than0.5%
0.07%
not more than 1.0%
0.10%
Residue on ignition（USP）
not more than 0.5%
0.00%
Related substances（Ph.Eur.）
Any individual impurity
0.38%
Not more than one such peak has area greater than 0.5%
Sum of impurities
not more than 1.5%
0.81%
Chromatographic purity（USP）
0.40%
not more than 2.0%
0.80%
Assay
UV Absorption（Ph.Eur.）
between 97.0% and 103.0%
100.4%
HPLC（USP）
between 97.0% and 102.0%
98.7%
Residual solvent（In-house）
Methanol
not more than 500ppm
3ppm
DMF
not more than 880ppm
563ppm
Pyridine
not more than 200ppm
not dectect out
Chloroform
not more than 60ppm
Particle size（In-house）
90% not more than 20 microns
CONCLUSION:THE PRODUCT CONFORMS TO Ph.Eur.6/USP36
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