China Manufacturing Landscape for Prostaglandin E1 (CAS 745-65-3)
Prostaglandin E1 (Alprostadil), the potent vasodilator and platelet aggregation inhibitor used in critical cardiovascular, neonatal, and urological applications, is manufactured at our production facility in Shanghai. As one of China’s most technically advanced API manufacturers, our Prostaglandin E1 production facility combines precision organic synthesis with ultra-clean processing to deliver this highly potent, injectable-grade API to pharmaceutical formulators worldwide. Direct manufacturer-direct supply ensures transparent pricing and reliable quality from a single accountable source.
The synthesis of Prostaglandin E1 demands exceptional chemical expertise due to the molecule’s complex stereochemistry, multiple chiral centers, and inherent chemical instability. Our synthetic chemistry team has accumulated deep expertise in prostaglandin synthesis over 12 years of continuous production, achieving the reproducible quality standards necessary for this challenging molecule.
Manufacturing Process & Facility
Our Prostaglandin E1 synthesis employs a convergent multi-step total synthesis approach featuring Corey lactone methodology. The process involves over 15 synthetic steps including asymmetric reactions, protective group chemistry, and controlled Wittig olefination to establish the required stereochemistry. Final purification combines preparative HPLC with controlled crystallization to achieve the exceptional purity demanded for injectable applications.
Key facility specifications:
- Specialized micro-reactor and small-batch synthesis equipment (1L to 200L scale)
- ISO Class 6 (Class 1,000) cleanroom for final purification and packaging — exceeding standard API requirements
- Ultra-cold storage capability (-20°C to -80°C) for temperature-sensitive intermediates
- Preparative HPLC systems with chiral columns for stereoisomeric purification
- Annual production capacity: 50 kg of pharmaceutical-grade Prostaglandin E1
- Nitrogen-atmosphere gloveboxes for moisture and oxygen-sensitive reaction steps
The small batch size and high number of synthetic steps make Prostaglandin E1 one of the most technically demanding APIs in our portfolio, requiring the highest levels of operator skill and process control.
Quality Standards & Multi-Pharmacopeial Compliance
Our Prostaglandin E1 API meets the stringent quality requirements for injectable formulations per USP, EP, and JP:
| Parameter | Specification | Test Method |
|---|---|---|
| Appearance | White to off-white crystalline powder | Visual |
| Identification | Positive by IR, HPLC, MS, specific rotation | IR/HPLC/MS/Polarimetry |
| Assay (anhydrous basis) | 97.0–103.0% | HPLC |
| Related Substances (total) | ≤2.0% | HPLC |
| PGE1 15-keto (degradation product) | ≤0.5% | HPLC |
| Any Other Single Impurity | ≤0.5% | HPLC |
| Bacterial Endotoxins | ≤0.5 EU/mg | LAL (kinetic turbidimetric) |
| Residual Solvents | Meets ICH Q3C | GC-HS |
| Elemental Impurities | Meets ICH Q3D (parenteral) | ICP-MS |
| Water Content | ≤1.0% | Karl Fischer |
Regulatory Documentation
Our Prostaglandin E1 regulatory dossier supports injectable product registrations in all major markets:
- US FDA Drug Master File (Type II) — active and maintained
- EU CEP application with EDQM
- Japan PMDA DMF — filed
- China NMPA registration
- Complete process validation with three consecutive commercial-scale batches
- ICH Q1A stability data (stored at -20°C) with 24-month results
- Forced degradation studies demonstrating analytical method specificity
- Elemental impurity and nitrosamine risk assessments
- Full stereochemical characterization confirming correct absolute configuration at all chiral centers
Given the complexity of prostaglandin chemistry, our regulatory package includes particularly detailed process descriptions and impurity characterization data to facilitate customer regulatory submissions.
Packaging & Logistics
Prostaglandin E1 packaging is designed for this highly sensitive, low-dose API:
- Primary: Amber glass vials, nitrogen-flushed, with PTFE-lined closures (1g, 5g, 10g units)
- Secondary: Insulated containers with gel packs for temperature maintenance
- Cold-chain shipping mandatory (-20°C or 2-8°C depending on customer specification)
- Temperature data loggers included in every shipment for chain-of-custody verification
- Shelf life: 24 months at -20°C, protected from light
All international shipments are handled by specialized cold-chain pharmaceutical logistics providers with validated temperature-controlled capabilities. Express courier options available for urgent small-quantity orders.
Competitive Pricing & Supply Reliability
Prostaglandin E1 is inherently a high-value, low-volume API where manufacturing expertise rather than scale drives competitiveness:
- Proprietary synthetic route optimized over 12 years of production experience
- In-house production of advanced chiral intermediates
- Experienced synthesis team with deep prostaglandin chemistry expertise
- Flexible batch sizing from 100g to multi-kilogram quantities
We offer competitive pricing reflective of our synthesis efficiency and overhead structure advantages compared to Western API manufacturers. Sample quantities for analytical and formulation evaluation are available on short lead times. Contact our specialty API division for quotations, technical documentation, and supply discussions.