Prednisolone Hemisuccinate is a synthetic corticosteroid ester and a derivative of prednisolone, belonging to the glucocorticoid class of pharmaceutical compounds. It is also known as Prednisolone 21-Hemisuccinate or Prednisolone Succinate. The compound is formed by esterification of the 21-hydroxyl group of prednisolone with succinic acid. Prednisolone Hemisuccinate has the molecular formula C₂₅H₃₂O₈ and a molecular weight of approximately 460.52 g/mol. Its CAS Number is 2920-86-7.
Prednisolone Hemisuccinate is distinct from Prednisolone Sodium Succinate. The free hemisuccinate is the hydrogen succinate form, whereas Prednisolone Sodium Succinate is the sodium salt and has a different molecular formula and molecular weight. Therefore, API identity, analytical methods, specifications, and documentation should always correspond to the exact requested form.
Product Name: Prednisolone Hemisuccinate
Synonyms: Prednisolone 21-Hemisuccinate; Prednisolone Succinate
CAS Number: 2920-86-7
Molecular Formula: C₂₅H₃₂O₈
Molecular Weight: 460.52 g/mol
API Class: Corticosteroid / Glucocorticoid
Chemical Type: Prednisolone ester / Hemisuccinate
Appearance: Fine creamy-white powder with friable lumps
Odour: Practically odorless
Prednisolone Hemisuccinate is chemically characterized as a prednisolone 21-hydrogen succinate ester. The compound retains the glucocorticoid steroid nucleus of prednisolone while incorporating the hemisuccinate moiety.
Prednisolone Hemisuccinate is a corticosteroid derivative associated with anti-inflammatory and glucocorticoid activity. Following administration, the hemisuccinate ester can undergo hydrolysis to release prednisolone. This ester form has been investigated and used in pharmaceutical and biomedical applications where the physicochemical characteristics of the ester are advantageous.
The compound is a steroidal molecule containing multiple hydroxyl groups, carbonyl functionalities and a succinate ester group. Its chemical structure gives it different physicochemical properties from unmodified prednisolone, including differences in polarity and solubility.
Prednisolone Hemisuccinate is associated with corticosteroid pharmaceutical applications involving the management of inflammatory and immune-mediated conditions. Prednisolone derivatives are widely used for their glucocorticoid and anti-inflammatory properties.
Prednisolone Hemisuccinate has historically been included in pharmaceutical compendial references and has been used as a pharmaceutical steroid ingredient. It may also serve as an intermediate or specialized corticosteroid ingredient in formulation development where the hemisuccinate ester is specifically required.
The exact dosage form, route of administration, concentration and formulation requirements depend on the finished pharmaceutical product and applicable regulatory requirements.
Quality control of Prednisolone Hemisuccinate requires confirmation of identity, assay, moisture content, stereochemical characteristics and physical properties.
A historical USP monograph specified 98.0–102.0% Prednisolone Hemisuccinate calculated on the dried basis. The same monograph specified loss on drying of NMT 0.5%, performed under vacuum at 65°C for 3 hours, and specific rotation of +99° to +104° using a 6.7 mg/mL solution in dioxane.
The historical USP identification procedures included infrared absorption and ultraviolet absorption. The UV identification procedure used a methanolic solution and evaluated absorptivity at approximately 243 nm.
For current commercial API release, analytical procedures should be validated for the specific manufacturing process and product specification. Where a numerical limit is not supported by a current universal compendial requirement, the specification should be established through appropriate quality and regulatory assessment rather than presenting an invented universal limit.
Prednisolone Hemisuccinate API requires controlled steroid manufacturing processes, appropriate analytical characterization and documented quality systems. An experienced Prednisolone Hemisuccinate API manufacturer in India can support pharmaceutical development and commercial requirements with controlled manufacturing, analytical testing and batch documentation.
Manufacturing controls should cover raw-material qualification, controlled processing, in-process monitoring, purification, drying, milling or particle-size control where applicable, packaging and final quality testing.
Each batch should be supported by appropriate analytical documentation, including identity, assay, moisture determination, physical description and other applicable quality attributes. The exact specification should be aligned with the customer's approved quality requirements and applicable regulatory expectations.
Prednisolone Hemisuccinate should be packed in suitable, well-closed or tight containers that protect the material from contamination and environmental exposure.
The historical USP monograph specified preservation in tight containers.
For reference-standard material, commercial analytical suppliers commonly recommend controlled storage such as 2–8°C.
For commercial API, the final storage condition should follow the manufacturer's validated stability data, approved packaging configuration and applicable product-specific requirements.
Typical documentation available for Prednisolone Hemisuccinate API can include:
Documentation should identify the exact API form as Prednisolone Hemisuccinate / Prednisolone 21-Hemisuccinate, CAS 2920-86-7, to avoid confusion with Prednisolone Sodium Succinate.
Prednisolone Hemisuccinate is an established corticosteroid derivative with a defined chemical identity and historical USP compendial specifications. Its quality assessment can be supported through orthogonal identification, chromatographic or validated assay procedures, moisture determination and stereochemical characterization.
Choosing a qualified Prednisolone Hemisuccinate API manufacturer in India helps pharmaceutical developers obtain material supported by controlled manufacturing practices, analytical testing and batch-specific documentation. For regulated pharmaceutical applications, the API specification should always correspond to the exact hemisuccinate form rather than being substituted with specifications for prednisolone or prednisolone sodium succinate.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Specific Rotation | 99° to +104° |