Description

Beclometasone Dipropionate Monohydrate is a synthetic glucocorticoid corticosteroid, widely recognized for its potent anti-inflammatory and immunosuppressive properties. This high-purity active pharmaceutical ingredient (API) is critical for ensuring the efficacy and safety of advanced pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers and research institutions developing inhalation therapies, topical creams, and nasal sprays for the treatment of asthma, allergic rhinitis, and various dermatological conditions.

Application

• Pharmaceutical API: Primary active ingredient in metered-dose inhalers (MDIs) and dry powder inhalers (DPIs) for asthma and COPD management.
• Topical Corticosteroid Formulations: Key component in creams, ointments, and lotions for treating eczema, psoriasis, and other inflammatory skin disorders.
• Nasal Spray Production: Used in the manufacture of nasal sprays for the relief of symptoms associated with allergic and non-allergic rhinitis.
• Veterinary Medicine: Employed in anti-inflammatory preparations for animal healthcare.
• Research & Development: Serves as a reference standard and key intermediate in pharmacological research and new drug development.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for the production of finished dosage forms.

Basic Information

Product Name	Beclometasone Dipropionate Monohydrate
CAS No.	77011-63-3
Molecular Formula	C28H37ClO7 • H2O
Molecular Weight	521.04 g/mol (Monohydrate)
Synonyms	Beclomethasone Dipropionate Monohydrate; 9-Chloro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate Monohydrate; BDP Monohydrate; Beclometasone 17,21-Dipropionate Monohydrate; Becloforte; Beconase; Vanceril; QVAR; Clipper; Propaderm
EINECS	Contact for details

Quality Control

Our Beclometasone Dipropionate Monohydrate is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical use. We can supply material compliant with major pharmacopoeial monographs, including USP, EP, and BP. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing purity, identity, and impurity profiles to support your regulatory filings and quality assurance processes.

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 or almost white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	3.0% - 4.5%
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Sulfated Ash	≤ 0.1%
Specific Optical 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.