Prednisolone Acetate is a synthetic corticosteroid active pharmaceutical ingredient used in the development and manufacture of corticosteroid medicines. It is the 21-acetate ester of prednisolone and belongs to the glucocorticoid class of pharmaceutical compounds. Prednisolone Acetate is particularly important in ophthalmic pharmaceutical formulations because of its anti-inflammatory and immunosuppressive activity.
Prednisolone Acetate has the CAS Number 52-21-1, molecular formula C₂₃H₃₀O₆, and molecular weight 402.48 g/mol. It is also known as Prednisolone 21-Acetate.
The API is characterized by established pharmacopoeial quality requirements covering identification, assay, loss on drying and specific optical rotation. These quality attributes are important for maintaining consistency, purity and performance in pharmaceutical manufacturing.
Prednisolone Acetate API is a small-molecule corticosteroid used as an active ingredient in pharmaceutical formulations. The material is generally described as a white to almost white crystalline substance and is practically insoluble in water.
The API is manufactured and tested according to applicable pharmaceutical quality requirements. Analytical evaluation may include infrared identification, ultraviolet identification, chromatographic assay, related-substance testing, loss on drying and specific rotation.
Prednisolone Acetate is chemically distinct from other prednisolone derivatives, including prednisolone sodium phosphate, prednisolone valerate acetate and prednisolone 11,21-diacetate. Therefore, the correct CAS number 52-21-1 should be used when identifying Prednisolone Acetate API.
Prednisolone Acetate is a synthetic glucocorticoid corticosteroid with a steroidal molecular structure containing hydroxyl, ketone and acetate functional groups.
Chemical Name: Prednisolone Acetate
CAS Number: 52-21-1
Molecular Formula: C₂₃H₃₀O₆
Molecular Weight: 402.48 g/mol
Synonym: Prednisolone 21-Acetate
API Type: Small-Molecule API
Pharmaceutical Class: Corticosteroid
Pharmacological Class: Glucocorticoid
Physical Form: White to almost white crystalline material
Water Solubility: Practically insoluble in water
PubChem identifies Prednisolone Acetate as a corticosteroid hormone and confirms its CAS number, molecular formula and molecular weight.
Prednisolone Acetate API is primarily used in pharmaceutical formulations requiring corticosteroid anti-inflammatory activity. It has an established role in ophthalmic pharmaceutical products and may be incorporated into suitable formulations according to applicable pharmaceutical and regulatory requirements.
Pharmaceutical applications include:
Prednisolone Acetate should be used in accordance with the approved indication, dosage form and regulatory requirements applicable to the finished pharmaceutical product.
Quality control of Prednisolone Acetate API involves analytical testing to establish identity, assay, purity and physical quality.
Important quality attributes include:
The USP monograph specifies an assay range of 97.0–102.0%, calculated on the dried basis. The applicable pharmacopoeial requirements also include loss on drying NMT 1.0% and specific optical rotation of +112° to +119°. These values should be used for the corresponding CMS specification fields rather than generic API limits.
Prednisolone Acetate API manufacturing requires controlled processing and appropriate analytical testing to maintain consistent pharmaceutical quality. Manufacturing controls should address raw-material quality, process parameters, impurity formation, moisture and final API characteristics.
A pharmaceutical-quality manufacturing system should include validated analytical procedures for identification, assay and related substances together with appropriate physical and chemical testing.
Prednisolone Acetate API should be released against an established specification appropriate to the intended pharmaceutical market, pharmacopoeial standard and customer requirements.
Prednisolone Acetate API should be packaged in suitable pharmaceutical-grade, well-closed containers to protect the material during storage and transportation.
The API should be stored under controlled environmental conditions and protected from excessive heat, moisture and unsuitable exposure. Actual commercial storage conditions should be based on validated stability data and the applicable product specification.
Appropriate packaging and storage controls help maintain the quality and stability of Prednisolone Acetate throughout its intended shelf life.
Prednisolone Acetate API documentation may include:
Documentation should correspond to the actual API batch and applicable quality specification.
Prednisolone Acetate is an established corticosteroid API requiring consistent control of assay, purity, optical rotation and moisture. Proper manufacturing controls and validated analytical testing are important for maintaining reliable API quality.
A quality-focused Prednisolone Acetate API manufacturing program should combine controlled production, analytical testing, batch traceability and appropriate pharmaceutical documentation.
Prednisolone Acetate API with pharmacopoeial-aligned quality testing can support pharmaceutical manufacturers involved in ophthalmic and other corticosteroid formulation development.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 97.0–102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.1% |
| Individual Impurity | NMT 0.5% |