Methylprednisolone Hemisuccinate is a water-soluble corticosteroid ester of methylprednisolone. It is a glucocorticoid derivative used in pharmaceutical preparations where a more water-soluble form of methylprednisolone is required.
Methylprednisolone Hemisuccinate is also known as methylprednisolone 21-hemisuccinate and is the parent compound used in the preparation of methylprednisolone sodium succinate. The USP identifies methylprednisolone hemisuccinate as C26H34O8, molecular weight 474.54 g/mol, CAS 2921-57-5.
Methylprednisolone Hemisuccinate is a specialized corticosteroid pharmaceutical API used in pharmaceutical development and manufacturing. Its quality evaluation includes assay, chromatographic purity, loss on drying, residue on ignition and other applicable analytical parameters.
CAS Number: 2921-57-5
Molecular Formula: C26H34O8
Molecular Weight: 474.54 g/mol
Chemical Name: Methylprednisolone Hemisuccinate
Synonyms: Methylprednisolone Succinate; Methylprednisolone 21-Hemisuccinate
Drug Class: Corticosteroid
Therapeutic Class: Glucocorticoid
Therapeutic Area: Anti-inflammatory / Immunosuppressive
Molecule Type: Synthetic Corticosteroid Ester
Methylprednisolone Hemisuccinate is converted to methylprednisolone-related active corticosteroid species and produces glucocorticoid effects through interaction with intracellular glucocorticoid receptors.
Corticosteroid activity can result in:
Methylprednisolone Hemisuccinate is associated with pharmaceutical applications involving:
Methylprednisolone sodium succinate preparations are used when rapid parenteral corticosteroid administration is required. USP documentation states that the injectable product can be prepared from methylprednisolone hemisuccinate using suitable sodium salts/bases.
The hemisuccinate is particularly relevant to:
Methylprednisolone Hemisuccinate is a corticosteroid ester supplied as a pharmaceutical solid. Exact appearance should be controlled according to the applicable monograph or validated manufacturer specification.
A controlled manufacturing process may involve:
USP monograph information provides specific numerical requirements for loss on drying and residue on ignition, as well as chromatographic purity testing.
Typical testing includes:
Store Methylprednisolone Hemisuccinate in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light.
Methylprednisolone Hemisuccinate is a corticosteroid ester with CAS 2921-57-5, molecular formula C26H34O8, and molecular weight 474.54 g/mol. USP identifies the substance as methylprednisolone hemisuccinate and provides a monograph for its quality control.
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder or crystals |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 97.0–103.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 1.0% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |