Hydrocortisone Acetate Injection

Corticosteroid.

Hydrocortisone Acetate Injection is a sterile suspension of Hydrocortisone Acetate in Water for Injections. It is prepared using aseptic technique.

The injection complies with the requirements stated under Parenteral Preparations and with the following requirements.

95.0 to 105.0% of the stated amount.

A white suspension that settles on standing but readily disperses on shaking. On examination under a microscope, the particles are seen to be crystalline and rarely exceed 30 µm in diameter.

Filter a volume containing 50 mg of Hydrocortisone Acetate through a sintered-glass filter, wash the residue with four 5-mL quantities of water, dissolve in 20 mL of chloroform, wash the chloroform solution with four 10-mL quantities of water, discard the washings, filter the chloroform solution through absorbent cotton and evaporate the filtrate to dryness. The residue complies with the following tests.

A. The infrared absorption spectrum, Appendix II A, is concordant with the reference spectrum of hydrocortisone acetate (RS 179).

B. Complies with the test for identification of steroids, Appendix III A, using impregnating solvent I and mobile phase B.

C. Yields the reaction characteristic of acetyl groups, Appendix VI.

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) dissolve 25 mg of hydrocortisone acetate BPCRS in 50 mL of methanol and add sufficient water to produce 100 mL. For solution (2) add 70 mL of methanol to a volume of the injection containing 50 mg of Hydrocortisone Acetate, shake to produce a clear solution and dilute to 100 mL with methanol. Dilute 10 mL of the resulting solution to 20 mL with water.

The chromatographic procedure may be carried out using (a) a stainless steel column (10 cm × 5 mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Spherisorb ODS 1 is suitable), (b) methanol (50%) as the mobile phase with a flow rate of 2 mL per minute and (c) a detection wavelength of 240 nm.

Calculate the content of C₂₃H₃₂O₆ in the preparation being examined using the declared content of C₂₃H₃₂O₆ in hydrocortisone acetate BPCRS.

Hydrocortisone Acetate Injection should be protected from light.

The label states (1) that it is intended for local action; (2) that the container should be gently shaken before a dose is withdrawn.