Methylprednisolone Sodium Succinate

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

Methylprednisolone Sodium Succinate contains NLT 97.0% and NMT 103.0% of methylprednisolone sodium succinate (C₂₆H₃₃NaO₈), calculated on the dried basis.

2 IDENTIFICATION

A. Infrared Absorption

Sample: 100 mg of Methylprednisolone Sodium Succinate

Analysis: Transfer the Sample to a separator, dissolve in 10 mL of water, add 1 mL of 3 N hydrochloric acid, and extract immediately with 50

mL of chloroform. Filter the chloroform extract through cotton, evaporate on a steam bath to dryness, and dry under vacuum at 60° for 3 h.

Acceptance criteria: The IR absorption spectrum of a Mineral oil dispersion of the residue so obtained exhibits maxima only at the same

wavelengths as those of a similar preparation of USP Methylprednisolone Hemisuccinate RS.

Change to read:

B. ▲Spectroscopic Identification Tests 〈197〉, Ultraviolet-Visible Spectroscopy: 197U▲ (CN 1-May-2020)

Standard solution: 20 µg/mL of USP Methylprednisolone Hemisuccinate RS in methanol

Sample solution: 20 µg/mL of Methylprednisolone Sodium Succinate in methanol

Analytical wavelength: 243 nm

Acceptance criteria: Absorptivities, calculated on the dried basis, do not differ by more than 3.0%.

C. The sample imparts an intense yellow color to a nonluminous flame.

3 ASSAY

Procedure

Solution A: 5 mg/mL of blue tetrazolium in alcohol

Solution B: Alcohol and tetramethylammonium hydroxide TS (9:1)

Standard solution: Proceed as directed for Assay for Steroids 〈351〉, Standard Preparation, preparing 12.5 µg/mL of USP Methylprednisolone

Hemisuccinate RS in alcohol.

Sample solution: 12.5 µg/mL of Methylprednisolone Sodium Succinate in alcohol

Blank: Alcohol

Instrumental conditions

Mode: Vis

Analytical wavelength: 525 nm

Analysis

Samples: Standard solution, Sample solution, and Blank

Pipet 20.0 mL of the Blank, Standard solution, and Sample solution into three different glass-stoppered, 50-mL conical flasks. Add 2.0 mL

of Solution A, and mix. To each flask add 4.0 mL of Solution B. Mix, and allow to stand in the dark for 90 min. Add 1.0 mL of glacial

acetic acid, and mix. Without delay, determine the absorbances of the Standard solution and the Sample solution against the Blank.

Calculate the percentage of methylprednisolone sodium succinate (C₂₆H₃₃NaO₈) in the portion of Methylprednisolone Sodium Succinate

taken:

Result = (Aᵤ / Aₛ) × (Cₛ / Cᵤ) × (Mᵤ / Mₛ) × 100

Aᵤ = absorbance of the Sample solution

Aₛ = absorbance of the Standard solution

Cₛ = concentration of USP Methylprednisolone Hemisuccinate RS in the Standard solution (µg/mL)

Cᵤ = concentration of Methylprednisolone Sodium Succinate in the Sample solution (µg/mL)

Mᵤ = molecular weight of methylprednisolone sodium succinate, 496.53

Mₛ = molecular weight of methylprednisolone hemisuccinate, 474.54

Acceptance criteria: 97.0%–103.0% on the dried basis

4 OTHER COMPONENTS

Sodium Content

Sample solution: Dissolve, with gentle heating, about 1 g of Methylprednisolone Sodium Succinate in 75 mL of glacial acetic acid. Add 20 mL

of dioxane, then add 1 drop of crystal violet TS.

Titrimetric system

Mode: Direct

Titrant: 0.1 N perchloric acid VS

Endpoint detection: Visual

Analysis: Titrate with Titrant to a blue-green endpoint. Perform a blank determination, and make any necessary correction. Each mL of Titrant

is equivalent to 2.299 mg of sodium (Na).

Acceptance criteria: 4.49%–4.77% on the dried basis

5 SPECIFIC TESTS

Optical Rotation 〈781S〉, Specific Rotation

Sample solution: 10 mg/mL of Methylprednisolone Sodium Succinate in alcohol

Acceptance criteria: +96° to +104°

Loss on Drying 〈731〉

Analysis: Dry at 105° for 3 h.

Acceptance criteria: NMT 3.0%

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight, light-resistant containers.

USP Reference Standards 〈11〉

USP Methylprednisolone Hemisuccinate RS