Hydrocortisone is a white to off-white crystalline powder, practically insoluble in water,sparingly soluble in acetone and in alcohol, slightly in methylene chloride. Hydrocortisone is an adrenal cortical hormone cortin drug, and it has glucose metabolism, anti-inflammatory, anti-allergic pharmacotherapy, and anti-venoms effects. It is mainly used in the replacement therapy of adrenal cortical dysfunction.

Specification

Appearance(Ph.Eur.)                                A white or almost white,crystalline powder

Specific optical rotation(Ph.Eur.)               150°~156°
Loss on drying(Ph.Eur.)                           Not more than 1.0%

Residue on ignition(USP)                         Not more than 0.5%
Related substances(Ph.Eur.)
Any individual impurity                            Not more than 0.5%
Sum of impurities                                    Not more than 1.5%
Chromatographic purity(USP)
Any individual impurity                            Not more than 0.5%
Sum of impurities                                    Not more than 2.0%
Assay
UV Absorption(Ph.Eur.)                            97.0%~103.0%
HPLC(USP)                                              97.0%~102.0%
Residual solvent(In-house)
Methanol                                                 Not more than 500ppm
Ethanol                                                   Not more than 2000ppm
Methylene chloride                                   Not more than 600ppm
Chloroform                                              Not more than 60ppm

Particle 90%                                            not more than 15microns

Application

Hydrocortisone is an adrenal cortical hormone cortin drug, and it has glucose metabolism, anti-inflammatory, anti-allergic pharmacotherapy, and anti-venoms effects. It is mainly used in the replacement therapy of adrenal cortical dysfunction.

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