Prednisolone Sodium Phosphate is a synthetic glucocorticoid corticosteroid and the disodium phosphate salt of prednisolone. It is chemically identified as 11β,17,21-trihydroxypregna-1,4-diene-3,20-dione 21-(disodium phosphate). The API has the molecular formula C₂₁H₂₇Na₂O₈P and molecular weight 484.39 g/mol, with CAS Number 125-02-0.
The phosphate salt provides different physicochemical characteristics from prednisolone itself and from other prednisolone derivatives such as Prednisolone Sodium Succinate and Prednisolone Hemisuccinate. Therefore, API identification, assay calculations and quality specifications should always correspond to the exact sodium phosphate form.
Prednisolone Sodium Phosphate is a glucocorticoid with anti-inflammatory and immunosuppressive activity. It is used in pharmaceutical formulations for corticosteroid therapy and is also used in ophthalmic preparations and other dosage forms depending on the approved formulation and route of administration. PubChem identifies the substance as a glucocorticoid, glucocorticoid receptor agonist and anti-inflammatory agent.
Product Name: Prednisolone Sodium Phosphate
Synonyms: Prednisolone 21-(Disodium Orthophosphate); Prednisolone Phosphate Sodium
CAS Number: 125-02-0
Molecular Formula: C₂₁H₂₇Na₂O₈P
Molecular Weight: 484.39 g/mol
API Class: Corticosteroid / Glucocorticoid
Chemical Type: Disodium phosphate ester of prednisolone
Appearance: White to almost white crystalline powder
Salt Form: Disodium phosphate
USP identifies Prednisolone Sodium Phosphate as the disodium phosphate salt of prednisolone and specifies its content on an anhydrous basis.
Prednisolone Sodium Phosphate is a phosphorylated derivative of prednisolone. Introduction of the phosphate group and sodium ions changes the physicochemical properties of the parent corticosteroid and provides a water-compatible salt form suitable for pharmaceutical formulation.
The compound contains the characteristic corticosteroid steroid nucleus together with hydroxyl, ketone and phosphate functionalities. Its molecular structure allows it to interact with glucocorticoid receptors and produce pharmacological effects associated with prednisolone.
Because the API is supplied as a disodium phosphate salt, its analytical specification should distinguish it from prednisolone free base and other prednisolone salts. USP specifically defines the material as C₂₁H₂₇Na₂O₈P and calculates assay on the anhydrous basis.
Prednisolone Sodium Phosphate is used as an active pharmaceutical ingredient in corticosteroid formulations. Prednisolone-based medicines are used for their anti-inflammatory and immunosuppressive effects in a range of clinical applications.
The sodium phosphate form is particularly relevant to pharmaceutical formulations where the salt's physicochemical properties are required. Prednisolone Sodium Phosphate is used in ophthalmic products and other corticosteroid dosage forms depending on the formulation and regulatory approval. PubChem records its role as an ophthalmology drug and anti-inflammatory agent.
The appropriate concentration, dosage form, administration route and formulation excipients depend on the finished pharmaceutical product and applicable regulatory requirements.
Prednisolone Sodium Phosphate has a defined USP-NF monograph. The USP specification states that the API contains NLT 96.0% and NMT 102.0% of Prednisolone Sodium Phosphate, calculated on the anhydrous basis.
The USP analytical profile includes infrared identification, identification of sodium and phosphate, specific optical rotation, pH, water determination, phosphate ions, selenium and related compounds. The current USP-based specification reports specific rotation of +95° to +102°, pH 7.5–10.5 and water content NMT 6.5%.
Related-compound testing is particularly important for corticosteroid APIs because structurally related degradation products and synthetic impurities may need to be controlled. Current USP-based commercial specifications report individual limits for several specified related compounds together with limits for unspecified impurities.
HPLC methods are also established in the scientific literature for determination of Prednisolone Sodium Phosphate and related substances, making chromatographic analysis appropriate for development and quality-control applications.
Prednisolone Sodium Phosphate API manufacturing requires controlled steroid chemistry, appropriate purification, drying and analytical testing. A qualified Prednisolone Sodium Phosphate API manufacturer in India can support pharmaceutical development and commercial requirements through controlled production and batch-specific quality documentation.
Manufacturing controls should cover raw-material qualification, process controls, purification, drying, particle-size requirements where applicable, packaging and final analytical testing.
Each batch should be evaluated against an approved specification appropriate to the intended pharmaceutical application. Identity, assay, water content, optical rotation, pH and related substances are important quality attributes for this API.
Prednisolone Sodium Phosphate should be protected from contamination and environmental exposure using suitable pharmaceutical packaging.
The USP monograph specifies preservation in tight containers.
The final storage conditions should be based on validated stability data, packaging configuration and applicable regulatory requirements.
Typical documentation for Prednisolone Sodium Phosphate API may include:
All documentation should clearly identify the material as Prednisolone Sodium Phosphate, CAS 125-02-0, to distinguish it from other prednisolone salts and derivatives.
Prednisolone Sodium Phosphate is an established corticosteroid API with a defined USP-NF monograph and clearly established analytical characteristics. The USP monograph specifies an anhydrous-basis assay range of 96.0–102.0%, specific rotation of +95° to +102°, pH 7.5–10.5 and water NMT 6.5%.
A qualified Prednisolone Sodium Phosphate API manufacturer in India can provide material supported by controlled manufacturing, analytical testing and batch-specific documentation. For pharmaceutical applications, specifications should always be established for the exact disodium phosphate API rather than being transferred from Prednisolone, Prednisolone Hemisuccinate or Prednisolone Sodium Succinate.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 96.0–102.0% |
| pH (1% Solution) | 7.5–10.5 |
| Individual Impurity | NMT 0.1% |
| Total Impurities | NMT 3.0% |
| Water Content | NMT 6.5% |
| Specific Rotation | +95° to +102° |