Description

Betamethasone Butyrate Propionate is a potent synthetic corticosteroid ester, representing a high-value active pharmaceutical ingredient (API) in the pharmaceutical industry. Its primary value lies in its enhanced topical anti-inflammatory and immunosuppressive activity, offering a critical therapeutic effect for managing severe dermatological conditions. This compound is essential for manufacturers developing advanced topical formulations, such as creams, ointments, and lotions, aimed at treating psoriasis, eczema, and other inflammatory skin disorders. The consistent quality and reliable supply of this API are paramount for ensuring the efficacy and safety of the final medicinal products.

Application

• Topical Corticosteroid Formulations: Primary active ingredient in prescription-strength creams, ointments, gels, and lotions for treating severe inflammatory skin conditions.
• Dermatological Therapeutics: Key component in medications for psoriasis, atopic dermatitis (eczema), contact dermatitis, and lichen planus.
• Veterinary Pharmaceuticals: Used in topical preparations for managing inflammatory skin diseases in animals.
• Clinical Research: Serves as a reference standard and raw material in pharmacological studies and new drug development for corticosteroid efficacy and delivery systems.
• Compounding Pharmacy: Utilized by specialized pharmacies to prepare customized topical medications for patients with specific therapeutic needs.

Basic Information

Product Name	Betamethasone Butyrate Propionate
CAS No.	5534-02-1
Molecular Formula	C₂₈H₃₇FO₇
Molecular Weight	504.59 g/mol
Synonyms	Betamethasone 17-Butyrate 21-Propionate; 9α-Fluoro-11β,17α,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-butyrate 21-propionate; Betamethasone Dipropionate (common misnomer); BBP; Betamethasone 17-Butyrate-21-Propionate Ester; (11β,16β)-9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione 17-butyrate 21-propionate
EINECS	226-879-5

Quality Control

Our Betamethasone Butyrate Propionate is manufactured under strict quality management systems, targeting compliance with pharmaceutical-grade standards. Each batch undergoes comprehensive analytical testing, including HPLC for assay and related substances, residual solvent analysis, and identity confirmation via IR and NMR. A Certificate of Analysis (COA) detailing all specifications and results is provided with every shipment to ensure full traceability and regulatory support for our customers' drug master files (DMF).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to almost white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Water (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Specific Rotation	+88° to +94° (c=1 in dioxane)

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