科研用氢化可的松,高标准原料现货质量报告单

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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

Specific optical rotation

（Ph.Eur.）	between +150°and+156°	+153.1°
（USP）	between +150°and+156°	+153.4°

Loss on drying

（Ph.Eur.）	not more than 1.0%	0.07%
（USP）	not more than 1.0%	0.04%

Residue on ignition（USP）

not more than 0.5%

0.00%

Related substances（Ph.Eur.）

Any individual impurity	not more than 0.5%	0.35%
Sum of impurities	not more than 1.5%	1.22%

Chromatographic purity（USP）

Any individual impurity	not more than 5.0%	0.32%
Sum of impurities	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）

Particle size（In-house）

90% not more than 15 microns

Complies

CONCLUSION:THE PRODUCT CONFORMS TO Ph.Eur.6/USP36

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