Description

Beclomethasonedipropionate-Bp/Ep/Usp is a high-purity synthetic corticosteroid active pharmaceutical ingredient (API). It is a critical component in the formulation of inhalation therapies for the management of chronic respiratory conditions. This product is manufactured to meet the stringent monographs of the British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP), ensuring global regulatory compliance. It is essential for pharmaceutical manufacturers specializing in asthma and COPD treatments.

Application

• Primary Pharmaceutical Ingredient: Core API in pressurized metered-dose inhalers (pMDIs) and dry powder inhalers (DPIs) for asthma control.
• Anti-inflammatory Formulations: Used in nasal sprays for the treatment of allergic rhinitis and nasal polyps.
• Generic Drug Manufacturing: Serves as the key component for producing generic versions of branded corticosteroid inhalers.
• Clinical Research & Development: Employed in preclinical and clinical studies for new respiratory drug delivery systems.
• Veterinary Pharmaceuticals: Potential use in anti-inflammatory treatments for animal respiratory conditions.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for finished dosage form production.

Basic Information

Product Name	Beclomethasonedipropionate-Bp/Ep/Usp
CAS No.	5532-09-8
Molecular Formula	C28H37ClO7
Molecular Weight	521.04 g/mol
Synonyms	Beclomethasone Dipropionate; Beclomethasone 17,21-Dipropionate; 9-Chloro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate; BDP; Becloforte; Beclovent; QVAR; Vanceril; Propaderm; Clenil; Aldecin; Sanasthmax; Sanasthmyl
EINECS	226-885-7

Quality Control

Our Beclomethasonedipropionate-Bp/Ep/Usp is produced under strict quality management systems in facilities compliant with cGMP. Every batch is tested against the full compendial specifications of BP, EP, and USP to ensure identity, potency, purity, and safety. A comprehensive Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and microbiological attributes is provided with each shipment to guarantee supply chain transparency and regulatory readiness for our global customers.

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 material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. The original container should be kept tightly sealed after each use.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on dried basis)
Related Substances (HPLC)	Total impurities: NMT 2.0% Any individual impurity: NMT 0.5%
Loss on Drying	NMT 1.0%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm
Microbiological Enumeration	Conforms to EP/USP requirements

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