Bulk Prostaglandins Manufacturer
High-Purity API Grade Analogues
Strategic industrial supply of high-potency Prostaglandins (PGE1, PGE2, PGF2α) and analogues. Validated for ophthalmic, cardiovascular, and trichological formulations with ≥ 99.5% chiral purity.
Technical R&D Dossier
Engineered for high-compliance drug delivery systems. We provide full structural verification (NMR/MS) and ICH stability protocols.
- ✓
Chiral Integrity: Stereospecific synthesis via Corey Lactone. - ✓
Stability Profile: 24-Month ICH-validated shelf life. - ✓
Regulatory: DMF/ASMF Technical Support available.
1H-NMR Verified | 13C-NMR Verified | LC-MS Fingerprinting
1. What are Prostaglandins? (Industrial Context)
Prostaglandins (PGs) are high-potency lipid compounds essential for regulating vascular tone, inflammation, and cellular signaling. In the industrial pharmaceutical sector, they are classified as HPAPIs (Highly Potent Active Pharmaceutical Ingredients) due to their microgram-level efficacy. AIHerba® specializes in the enantioselective total synthesis of these compounds, ensuring the absolute stereochemical purity required for high-end ophthalmic and cardiovascular applications.
2. Critical Physiochemical Specifications
| Testing Parameter | Industrial/Pharma Standard | AIHerba® Platform Result |
|---|---|---|
| Assay (HPLC, Anhydrous) | 98.0% – 102.0% | ≥ 99.7% |
| Chiral Purity (Enantiomeric) | Individual Impurity ≤ 0.5% | ≤ 0.15% (15-epi Control) |
| Residual Solvents (USP <467>) | ICH Class 2 & 3 Compliance | Toluene & Ethanol < 50 ppm |
| Loss on Drying | ≤ 0.5% | 0.12% (Anhydrous Processing) |
3. Source & Manufacturing Origin
AIHerba® Prostaglandins are produced via Total Chemical Synthesis starting from high-purity Corey Lactone Diol. Unlike animal-derived extraction, our biomimetic synthesis pathway ensures a 100% Vegan, TSE/BSE-free product with absolute batch-to-batch consistency in molecular habit.
4. Mechanism of Action (Cellular Signaling)
Prostaglandins function as ligands for G-protein coupled receptors (GPCRs), specifically the EP and FP receptor families. In ophthalmic solutions, they modulate uveoscleral outflow; in dermatological research, they prolong the anagen phase of hair follicles by mimicking natural endogenous lipids.
5. Industrial Application Verticals
Ophthalmic API
Primary active for advanced glaucoma treatments and intraocular pressure regulation solutions.
Trichological Research
Specialized analogues (Bimatoprost/Latanoprost) for lash enhancement and hair density formulations.
Reproductive Research
Critical precursors for labor induction studies and cell-signaling research in obstetric medicine.
6. Usage & Formulation Engineering Guide
Solubility & pH Optimization
Prostaglandins are inherently hydrophobic. Optimal stability is maintained at pH 4.5 – 5.5. They are soluble in Ethanol, DMSO, and DMF. For aqueous systems, we recommend the use of hydroxypropyl-beta-cyclodextrin to enhance solubility and prevent adsorption to glass/plastic surfaces.
HPAPI Handling Protocols
Due to high physiological activity, use an OEB 5 containment isolator. Handling temperature must not exceed 25°C during formulation to prevent Indole ring cleavage. Always use anhydrous solvents for initial dilution.
7. Industrial Evolution: From Lab Synthesis to OEB 5 Global Supply
8. Batch-Specific Quality Control Dossier
| HPLC Chiral Purity | Individual Isomer ≤ 0.1% | PASS |
| Structural Identification | 1H-NMR & 13C-NMR Spectrum Match | CONFORMS |
| Lead (Pb) / Arsenic (As) | ≤ 0.1 ppm / ≤ 0.1 ppm | < 0.05 ppm |
| Total Plate Count | ≤ 100 cfu/g (Strictly Controlled) | ND |
9. Manufacturing Flow
Synthesis → Flash Chromatography → Chiral HPLC Separation → Crystallization → Nitrogen Sealing.
10. Storage & Packaging
Sealed in Amber glass under Argon. Ships in Dry Ice (-20°C / -80°C validated shippers).
11. MOQ & Shipping
1g samples to 500g+ batches. DDP global express available.
12. Clinical Citations
Referencing 2,500+ PubMed studies on Prostaglandin efficacy in ophthalmic drug delivery.
13. Industries Served
Pharma API, Biotech Research, Cosmetic R&D Labs.
15. Real-world Impact
Supplying 12 of the Top 50 global ophthalmology labs with batch-consistent analogues.
16. Technical Supplier Benchmark
17. Technical & Logistics FAQ
Why is chiral purity critical for Prostaglandin analogues?+
How do you ensure the stability of Prostaglandins during transit?+
Is AIHerba’s manufacturing facility GMP audited?+
What is the typical lead time for a 1kg batch of PGE1?+
Do you provide support for US-FDA or EU-EMA filings?+
18. Technical References & Regulatory Monographs
USP Monograph: Latanoprost / Alprostadil | EP Monograph: Dinoprostone | ICH Q3C Guidelines for Residual Solvents | OEB 5 Containment Standards.
