Prednicarbate is a synthetic topical corticosteroid used as an active pharmaceutical ingredient in dermatological formulations. It belongs to the glucocorticoid class and is used for the management of inflammatory and pruritic manifestations of corticosteroid-responsive skin conditions.
Prednicarbate has the CAS Number 73771-04-7, molecular formula C₂₇H₃₆O₈, and molecular weight 488.57 g/mol. It is also identified by the FDA Global Substance Registration System under UNII V901LV1K7D.
The USP-NF monograph defines Prednicarbate as containing 97.0–102.0% of Prednicarbate, calculated on the dried basis. The pharmacopoeial quality profile also includes specific optical rotation, loss on drying and chromatographic controls for related substances.
Prednicarbate API is a synthetic corticosteroid active pharmaceutical ingredient primarily associated with topical dermatological pharmaceutical products. It is a medium-potency topical corticosteroid and is used in formulations intended for corticosteroid-responsive inflammatory and pruritic dermatoses.
The API is generally obtained as a white to off-white crystalline material. Prednicarbate is practically insoluble in water and has substantially greater solubility in selected organic solvents such as acetone and ethanol.
Prednicarbate should be distinguished from other corticosteroid APIs and derivatives because the pharmaceutical identity, specification and regulatory requirements are specific to the individual active substance.
Prednicarbate is a synthetic glucocorticoid containing a corticosteroid steroid nucleus with ethoxycarbonyl and propionate ester functionalities.
Chemical Name: Prednicarbate
CAS Number: 73771-04-7
Molecular Formula: C₂₇H₃₆O₈
Molecular Weight: 488.57 g/mol
UNII: V901LV1K7D
ChEBI: CHEBI:135791
API Type: Small-Molecule API
Pharmaceutical Class: Corticosteroid
Pharmacological Class: Glucocorticoid
Physical Form: Crystalline solid
Water Solubility: Insoluble
Organic Solubility: Soluble in acetone and ethanol
The chemical identity and molecular information are supported by PubChem, USP and pharmaceutical reference-standard data.
Prednicarbate API is primarily used in the manufacture and development of topical dermatological corticosteroid formulations.
Its pharmaceutical applications include:
Prednicarbate 0.1% cream and ointment are described as medium-potency topical corticosteroid preparations.
Quality control of Prednicarbate API includes analytical procedures designed to establish identity, assay, purity and physical quality.
The USP-NF specification defines:
The USP chromatographic impurity procedure also disregards chromatographic peaks below the specified reporting threshold of 0.0125%.
These analytical controls help establish consistent API identity, potency and chromatographic purity.
Prednicarbate API manufacturing requires controlled synthetic processing and appropriate analytical testing to maintain consistent pharmaceutical quality. Manufacturing controls should address raw-material quality, process parameters, impurity formation, residual moisture and final API characteristics.
A pharmaceutical-quality manufacturing system should use validated analytical procedures for identification, assay and related substances, together with appropriate physical and chemical testing.
Prednicarbate API should be released against an established specification appropriate to the intended pharmaceutical market and applicable pharmacopoeial requirements.
Prednicarbate should be preserved in well-closed, light-resistant containers according to the USP-NF monograph.
Suitable pharmaceutical-grade packaging should protect the API from excessive environmental exposure during storage and transportation.
Recommended storage wording:
Store in well-closed, light-resistant containers under controlled environmental conditions. Protect from excessive heat, moisture and direct light. Storage conditions should follow validated stability data and the applicable product specification.
Prednicarbate API documentation may include:
Documentation should correspond to the actual manufacturing batch and applicable quality specification.
Prednicarbate is a specialized topical corticosteroid API requiring controlled assay, chromatographic purity, optical rotation and moisture characteristics.
A quality-focused Prednicarbate API manufacturing program should combine controlled production processes, validated analytical testing, batch traceability and comprehensive pharmaceutical documentation.
Pharmacopoeial-aligned testing provides defined controls for 97.0–102.0% assay, NMT 0.5% loss on drying, +60° to +66° specific rotation and NMT 2.0% total impurities, supporting consistent API quality for pharmaceutical formulation and development.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 97.0–102.0% |
| Loss on Drying | NMT 0.5% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |