Description

Alprostadil Alfadex is a pharmaceutical-grade inclusion complex of the vasodilator Alprostadil with Alfadex (α-Cyclodextrin), designed to enhance the stability and solubility of the active pharmaceutical ingredient. This formulation is critical for ensuring consistent potency and reliable performance in sensitive medical applications. It is primarily utilized by pharmaceutical manufacturers and research institutions developing treatments for erectile dysfunction and severe peripheral vascular diseases, where precise dosing and product integrity are paramount.

Application

• Pharmaceutical Formulations: As the active ingredient in injectable solutions for the treatment of erectile dysfunction (ED).
• Vascular Therapy: Used in medications for managing severe peripheral arterial occlusive disease and maintaining ductus arteriosus patency in neonates.
• Research & Development: Serves as a key reference standard and intermediate in pharmacological and clinical research studies.
• Drug Delivery Systems: Exploited in advanced delivery platforms where the cyclodextrin complex improves bioavailability and controls release kinetics.
• GMP Manufacturing: Integrated into Good Manufacturing Practice (GMP) processes for the production of sterile parenteral drugs.

Basic Information

Product Name	Alprostadil Alfadex
CAS No.	55648-20-9
Molecular Formula	C₂₀H₃₄O₅ • (C₃₆H₆₀O₃₀)ₓ
Molecular Weight	Contact for details
Synonyms	Alprostadil α-Cyclodextrin Complex; PGE1-Alfadex; Prostaglandin E1-Alfadex; Alprostadil Alfadex Inclusion Compound; Alfadex-stabilized Alprostadil; PGE1 with α-Cyclodextrin; 11α,15α-Dihydroxy-9-oxoprosta-5,13-dien-1-oic acid Alfadex complex
EINECS	Contact for details

Quality Control

Our Alprostadil Alfadex is manufactured under strict quality systems to meet the exacting standards of the pharmaceutical industry. Each batch is tested to ensure identity, purity, potency, and complexation ratio, with specifications aligned with pharmacopeial guidelines. Certificates of Analysis (COA) documenting full compliance are available upon request to support your regulatory and quality assurance requirements.

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 under conditions that minimize exposure to atmospheric humidity to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference
Assay (Alprostadil)	98.0% - 102.0%
Complexation Ratio	As per customer specification
Water Content (KF)	≤ 5.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Bacterial Endotoxins	< 10.0 EU/mg
Microbial Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13

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