Product Description:  

Hydrocortisone CAS 50-23-7 is a white crystalline powder and it is insoluble in water but soluble in acetone and ethanol. Hydrocortisone is the treatment of choice for adrenocortical insufficiency. It can be given by mouth or by injection. After long term use, if stopped this should be done slowly. Hydrocortisone is the pharmaceutical term for cortisol used in oral administration, intravenous injection, or topical application.

Specifications: 

CP 2005:

Appearance:                white or almost white crystalline powder, odorless 

Identification:               it should be positive 

Specific rotation:                 +162°~+169°

Absorptive index:                422~488

Related substance:              prednisone≤0.5%, any other single impurity ≤0.55, 

Any unknown impurity         ≤1.5%

Loss on drying:                   ≤0.5%

USP36/EP6:

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

Solubility(Ph.Eur.)(annual) Practically insoluble in water,sparingly soluble in acetone and in alcohol,slightly in methylene chloride

Identification

A. IR-spectrum(Ph.Eur./USP) Meet the requirement

B. TLC(Ph.Eur.)                 Meet the requirement

C. UV Absorption(USP)   Meet the requirement

Specific optical rotation(Ph.Eur.）

(USP)                        150°~156°

                                       150°~156°

Loss on drying(Ph.Eur.)

(USP)                         Not more than 1.0%

                                        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:

For treatment of choice for adrenocortical insufficiency.