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喜樹(shù)堿 黃體酮 噻菌靈/噻苯咪唑 硫酸新霉素 紅霉素
Product Name:
Hydrocortisone
Manuf. Date:
2019.08.10
Quantity:
10g
Retest Date:
2023.08.09
Package:
Drum or carton
Report Date:
2019.08.28
Items
Requirements
Results
Appearance（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
Idenitification
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 +150°and+156°
+153.1°
（USP）
+153.4°
Loss on drying
not more than 1.0%
0.07%
0.04%
Residue on ignition（USP）
not more than 0.5%
0.00%
Related substances（Ph.Eur.）
Any individual impurity
0.35%
Sum of impurities
not more than 1.5%
1.22%
Chromatographic purity（USP）
not more than 5.0%
0.32%
not more than 2.0%
1.32%
Assay
UV Absorption（Ph.Eur.）
between 97.0% and 103.0%
100.6%
HPLC（USP）
between 97.0% and 102.0%
100.3%
Residual solvent（In-house）
Methanol
not more than 500ppm
1ppm
Ethanol
not more than 2000ppm
340ppm
Methylene chloride
not more than 600ppm
not dectect out
Chloroform
not more than 60ppm
Particle size（In-house）
90% not more than 15 microns
CONCLUSION:THE PRODUCT CONFORMS TO Ph.Eur.6/USP36
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