Description

Diflucortolone Pivalate is a potent synthetic corticosteroid belonging to the glucocorticoid class, specifically formulated as the pivalate ester derivative of diflucortolone. This compound is valued for its significant anti-inflammatory and immunosuppressive properties, making it a critical active pharmaceutical ingredient (API) in topical dermatological formulations. It is primarily required by pharmaceutical manufacturers and research institutions developing treatments for severe skin conditions such as eczema, psoriasis, and contact dermatitis.

Application

• Topical Corticosteroid Preparations: As the key API in creams, ointments, and lotions for treating inflammatory skin disorders.
• Dermatological Research: Used in preclinical and clinical studies to investigate mechanisms of anti-inflammatory action and develop new topical therapies.
• Pharmaceutical Intermediates: Serves as a crucial intermediate in the synthesis of more complex steroid-based pharmaceutical compounds.
• Veterinary Medicine: Incorporated into topical treatments for managing skin inflammation and allergic conditions in animals.
• Compounding Pharmacy: Utilized by specialized pharmacies to prepare customized topical formulations for specific patient needs.

Basic Information

Item	Details
Product Name	Diflucortolone Pivalate
CAS No.	15845-96-2
Molecular Formula	C27H36F2O5
Molecular Weight	478.57 g/mol
Synonyms	6α,9α-Difluoro-11β,21-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 21-pivalate; Diflucortolone 21-pivalate; 6α,9α-Difluoro-16α-methylprednisolone 21-pivalate; NSC-121773; Diflucortolone Pivalate (USAN); Flucort; Nerisone (as the active ingredient); Diflucortolone 17-valerate (common misnomer)
EINECS	Contact for details

Quality Control

Our Diflucortolone Pivalate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications. We provide detailed Certificates of Analysis (COA) that include identity confirmation, assay, impurity profile, and residual solvent analysis, supporting compliance with cGMP and relevant pharmacopoeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Loss on Drying	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C guidelines

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.