Description

Prostaglandin E1 α-Cyclodextrin Clathrate Compound is a sophisticated inclusion complex designed to enhance the stability and solubility of the biologically active prostaglandin E1 (Alprostadil). This advanced formulation matters because it overcomes the inherent instability and poor water solubility of the native prostaglandin, enabling more reliable and effective pharmaceutical applications. It is primarily needed by pharmaceutical manufacturers and research institutions developing treatments for cardiovascular conditions, such as peripheral arterial disease and erectile dysfunction, as well as for use as a vasodilator in critical care settings.

Application

• Pharmaceutical Active Ingredient (API): Core component in injectable formulations for the treatment of peripheral arterial occlusive disease (PAOD) and critical limb ischemia.
• Vasodilatory Therapy: Used in hospital settings for maintaining ductus arteriosus patency in neonates with congenital heart defects or as a vasodilator in certain surgical procedures.
• Erectile Dysfunction Treatment: Serves as the active pharmaceutical ingredient in intracavernosal injection therapies (e.g., Caverject).
• Research & Development: A critical reference standard and tool for pharmacological studies in vascular biology, smooth muscle physiology, and inflammation.
• Drug Delivery Enhancement: Exemplifies the use of cyclodextrin complexation technology to improve the bioavailability and shelf-life of sensitive therapeutic agents.

Basic Information

Product Name	Prostaglandin E1 α-Cyclodextrin Clathrate Compound
CAS No.	93591-00-5
Molecular Formula	C20H34O5 • (C36H60O30)x
Molecular Weight	Variable (Complex)
Synonyms	Alprostadil Alfadex; PGE1-α-Cyclodextrin Clathrate; Alprostadil α-Cyclodextrin Inclusion Complex; Prostaglandin E1-α-CD; 11α,15S-Dihydroxy-9-oxoprosta-5Z,13E-dien-1-oic acid α-cyclodextrin complex; Liple; Caverject Impuls (referencing finished product); PGE1 Complex with α-Cyclodextrin
EINECS	Contact for details

Quality Control

Our Prostaglandin E1 α-Cyclodextrin Clathrate Compound is manufactured under strict quality management systems suitable for pharmaceutical applications. Quality control adheres to in-house specifications aligned with ICH guidelines, ensuring high purity, correct complexation ratio, and the absence of critical impurities. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing identity, assay, related substances, residual solvents, and microbiological quality. We support compliance with cGMP standards for active pharmaceutical ingredients (APIs).

Storage

Preserve in a tightly closed container, protected from light. Store in a freezer at -20°C or below for long-term stability. Under these conditions, the product is typically stable for at least 24 months. Allow the sealed container to reach room temperature before opening to prevent condensation and moisture ingress. The product should be handled in a controlled environment to maintain its integrity.

Specification

Item	Specification
Appearance	White to off-white powder or porous mass
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	90.0% - 110.0% of labeled amount of Alprostadil
Complexation Ratio (PGE1:α-CD)	As per label claim (e.g., ~1:2 molar ratio)
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single impurity ≤ 2.0%
Water Content (KF)	≤ 10.0%
Residual Solvents (GC)	Complies with ICH Q3C
Bacterial Endotoxins	< 50 EU/mg (if for injectable use)
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.