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A comprehensive analysis on structural synthesis, micronization physics, cGMP quality benchmarks, global regulatory pathways, and procurement dynamics for steroid active pharmaceutical ingredients.
Estradiol Valerate (CAS Number: 313-06-4, Molecular Formula: C₂₃H₃₂O₃, Molecular Weight: 356.50 g/mol) is a synthetic esterified derivative of natural 17β-estradiol. Chemical esterification at the C17-hydroxyl position with valeric acid creates a lipophilic prodrug designed to attenuate systemic clearance and ensure sustained therapeutic release following oral administration or depot intramuscular delivery.
As a leading High-Quality Estradiol Valerate Supplier, Gentolex implements strict control over polymorph generation, crystal structure, and stereospecificity. The introduction of the valerate ester moiety substantially increases lipid solubility, rendering it ideal for lipid-based oral delivery systems, oil-based injectable solutions, and transdermal dosage forms.
Estradiol Valerate serves as an essential API across primary global pharmaceutical sectors:
Information Gain Insight: Modern micronization technologies enable custom particle size distribution (PSD) profiles tailored for specific drug delivery matrices. For injectable suspension formulations, achieving a narrow D90 < 10 µm prevents needle clogging and ensures predictable hydrolysis rates by plasma esterases.
| Analytical Parameter | Methodology | EP / USP Target Specification | Gentolex Commercial Benchmark |
|---|---|---|---|
| Appearance | Visual Inspection | White or almost white crystalline powder | White Crystalline Powder (Conforms) |
| Chemical Identification | FTIR / UV-Vis Spectroscopy | Conforms to Reference Standard | 100% Structural Match (FTIR & NMR verified) |
| Assay (Dry Basis) | HPLC-UV | 97.0% – 103.0% | 99.2% – 100.5% (High Purity API) |
| Related Substances (Impurities) | RP-HPLC | Single Impurity ≤ 0.5%, Total ≤ 1.0% | Single Impurity < 0.10%, Total < 0.30% |
| Melting Point | Capillary Method | 144 °C to 150 °C | 145.5 °C – 147.5 °C |
| Specific Optical Rotation | Polarimetry | +41.0° to +45.0° | +42.5° to +44.0° |
| Loss on Drying | Gravimetric (105°C) | ≤ 0.5% | ≤ 0.15% |
| Residual Solvents | Headspace GC-FID | Meets ICH Q3C Guidelines | Ethanol < 500 ppm, Methanol < 100 ppm |
| Bacterial Endotoxins | LAL Kinetic Chromogenic | < 0.5 EU/mg (Injectable Grade) | Ultra-low endotoxin validation available |
Our high-efficiency esterification roadmap minimizes byproduct generation, eliminates heavy metal residue, and guarantees continuous batch-to-batch consistency.
Natural 17β-estradiol is reacted with valeric anhydride or valeryl chloride in pyridine or organic solvent complexes under controlled temperature dynamics. Regioselectivity is maintained to prevent unwanted derivatization at the phenolic C3-hydroxyl group.
If diester formation occurs, controlled mild alkaline hydrolysis selectively cleaves the C3-valerate ester while retaining the stable C17-valerate ester. Recrystallization from ethanol-water or organic solvents isolates pristine crystalline product.
The purified bulk API undergoes fluid energy jet milling under inert nitrogen purging. Laser diffraction particle sizing ensures exact adherence to D10, D50, and D90 parameters tailored to client formulation specifications.
Navigating international regulatory frameworks, cold-chain transport imperatives, and dual-sourcing requirements for active pharmaceutical ingredient supply.
Procuring pharmaceutical-grade Estradiol Valerate requires stringent compliance documentation. Gentolex supports global market authorization applications (MAA/NDA/ANDA) by providing complete dossier suites:
Gentolex has established localized support nodes in over 10 countries, including dedicated commercial hubs in Mexico and South Africa. Our logistics framework offers guaranteed customs clearance support, temperature-monitored air-freight packaging, and flexible batch volume options from trial R&D quantities to metric-ton scale production.
Creating global opportunities by connecting life science organizations with precision services and guaranteed pharmaceutical raw materials.
Gentolex’s goal is to create opportunities connecting the world with better services and guaranteed products. Up to date, Gentolex Group has been serving customers from more than 10 countries, specially, representatives are established in Mexico and South Africa. Our main services focus on supplying peptides APIs and Custom Peptides, FDF license out, Technical Support & Consultation, Product Line and Lab Setup, Sourcing & Supply Chain Solutions.
Our infrastructure encompasses an overall factory construction area of 250,000 square meters designed under international cGMP standards, providing flexible, scalable, and cost-effective solutions for active chemical synthesis and peptide production worldwide.
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An overall factory construction area of 250,000 square meters under international standard to offer flexible, scalable and cost-effective solutions.
Gentolex offers an extensive range of APIs and intermediates for development study and commercial application with cGMP standard from long-term collaborations. Documents and Certificates are supported to customers worldwide.
Custom synthesis routes, impurity isolation, structural characterization, and tech transfer for clinical and commercial pharmaceutical pipelines.
For those clients who prefer to avoid the complexity of dealing with multiple points of contact, we provide extra customized procurement services with the most superior and comprehensive supply chain sources.
Stay updated with research advancements, API manufacturing breakthroughs, and peptide engineering updates from our technical division.
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View DetailsAddressing key technical, regulatory, and logistics queries for Estradiol Valerate and chemical API sourcing.
Additional commercial pharmaceutical ingredients, advanced peptides, and inorganic catalysts provided by Gentolex Group.
