醋酸氢化可的松50-03-3COA

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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℃

Specific optical rotation

（Ph.Eur.）	between +158°and+167°	+163.0°
（USP）	between +158°and+165°	+162.9°

Loss on drying

（Ph.Eur.）	not more than0.5%	0.07%
（USP）	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	not more than 1.0%	0.38%
	Not more than one such peak has area greater than 0.5%	Complies
Sum of impurities	not more than 1.5%	0.81%

Chromatographic purity（USP）

Any individual impurity	not more than 1.0%	0.40%
Sum of impurities	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）

Particle size（In-house）

90% not more than 20 microns

Complies

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

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