Hydrocortisone Sodium Succinate for Injection
» Hydrocortisone Sodium Succinate for Injection is a sterile mixture of Hydrocortisone Sodium Succinate and suitable buffers. It may be prepared from Hydrocortisone Sodium Succinate, or from Hydrocortisone Hemisuccinate with the aid of Sodium Hydroxide or Sodium Carbonate. It contains the equivalent of not less than 90.0 percent and not more than 110.0 percent of the labeled amount of hydrocortisone (C21H30O5) in single-compartment containers, or in the volume of solution designated on the label of containers that are constructed to hold in separate compartments the Hydrocortisone Sodium Succinate for Injection and a solvent.
Packaging and storage Preserve in Containers for Sterile Solids as described under Injections 1.
Labeling Label it to indicate that the constituted solution prepared from Hydrocortisone Sodium Succinate for Injection is suitable for use only if it is clear, and that the solution is to be discarded after 3 days. Label it to indicate that it was prepared by freeze-drying, having been filled into its container in the form of a true solution.
USP Reference standards 11
USP Endotoxin RS
Constituted solution At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
Identification It meets the requirements for Identification test A under Hydrocortisone Sodium Succinate.
Bacterial endotoxins 85 It contains not more than 1.25 USP Endotoxin Units per mg of hydrocortisone.
pH 791: between 7.0 and 8.0, in a solution containing the equivalent of 50 mg of hydrocortisone per mL.
Loss on drying 731 Dry it at 105 for 3 hours: it loses not more than 2.0% of its weight.
Particulate matter 788: meets the requirements for small-volume injections.
Free hydrocortisone Using the chromatograms obtained in the Assay, measure the areas of the peaks from the internal standard and free hydrocortisone. Calculate the ratio of the area of the free hydrocortisone peak to that of the internal standard in the chromatogram obtained from the Standard preparation, SS, and the same ratio in the chromatogram obtained from the Assay preparation, SU. Calculate the quantity, in mg, of free hydrocortisone in the Assay preparation taken by the formula:
(100C)(SU / SS)in which C is the concentration, in mg per mL, of USP Hydrocortisone RS in the Standard preparation; and SU and SS are the ratios as defined above. The amount of free hydrocortisone is not more than 6.7% of the labeled amount of hydrocortisone.
Other requirements It meets the requirements for Sterility Tests 71, Uniformity of Dosage Units 905, and Labeling under Injections 1.
Internal standard solution and Mobile phasePrepare as directed in the Assay under Hydrocortisone Hemisuccinate.
Standard preparation Weigh accurately about 32.5 mg of USP Hydrocortisone Hemisuccinate RS, and transfer it to a 50-mL volumetric flask. Add by pipet 5.0 mL of Internal standard solution and 5.0 mL of a solution of glacial acetic acid in chloroform (3 in 100) containing in each mL an accurately known quantity of about 0.30 mg of USP Hydrocortisone RS. Dilute with glacial acetic acid in chloroform (3 in 100) to volume, and mix.
Assay preparation Mix the constituted solutions prepared from the contents of 10 vials of Hydrocortisone Sodium Succinate for Injection. Transfer an accurately measured volume of the resulting constituted solution, equivalent to about 50 mg of hydrocortisone, to a suitable flask containing 10.0 mL of Internal standard solution and dilute with glacial acetic acid in chloroform (3 in 100) to 100.0 mL. Shake thoroughly for 5 minutes, then allow the phases to separate, discarding the upper phase.
Procedure Proceed as directed for Procedure in the Assay under Hydrocortisone Hemisuccinate. The order of elution of peaks is that from the internal standard, hydrocortisone hemisuccinate, and successive smaller peaks representing free hydrocortisone and hydrocortisone 17-hemisuccinate, whose relative retention times are about 1.0, 1.5, 2.0, and 2.5, respectively. Measure the areas of the peaks from the internal standard, hydrocortisone hemisuccinate, and hydrocortisone 17-hemisuccinate. Calculate the ratio of the summation of the areas of the hydrocortisone hemisuccinate and hydrocortisone 17-hemisuccinate peaks to that of the internal standard in the chromatogram obtained from the Standard preparation, RS, and the same ratio in the chromatogram obtained from the Assay preparation, RU. Calculate the quantity, in mg, of hydrocortisone (C21H30O5) in the portion of constituted solution taken by the formula:
0.784(100C)(RU / RS)in which 0.784 is the ratio of the molecular weight of hydrocortisone to that of hydrocortisone hemisuccinate; C is the concentration, in mg per mL, of USP Hydrocortisone Hemisuccinate RS in the Standard preparation; and RU and RS are the ratios as defined above, and to this quantity add the amount, in mg, of free hydrocortisone found in the test for Free hydrocortisone.
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USP35NF30 Page 3442