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Oestradiol 17-Heptanoate

    • Product Name Oestradiol 17-Heptanoate
    • Alias Estradiol enantate
    • Einecs 200-350-6
    • Mininmum Order 1 g
    • Factory Site Tengfei Creation Center,55 Jiangjun Avenue, Jiangning District,Nanjing
    • Price Inquiry admin@sinochem-nanjing.com
    • Manufacturer Sinochem Nanjing Corporation
    • CONTACT NOW
    VTB
    Specifications

    HS Code

    568120

    Chemical Name Oestradiol 17-Heptanoate
    Synonyms Estradiol enanthate
    Molecular Formula C25H36O3
    Molar Mass 384.55 g/mol
    Cas Number 4956-37-0
    Appearance White or almost white crystalline powder
    Solubility Practically insoluble in water, soluble in ethanol and oils
    Melting Point 42-44°C
    Route Of Administration Intramuscular injection
    Pharmacological Class Estrogen
    Drug Type Synthetic estrogen ester
    Half Life Approx. 5-8 days (depot injection)
    Usage Hormone replacement therapy, contraception

    As an accredited Oestradiol 17-Heptanoate factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.

    Packing & Storage
    Packing Oestradiol 17-Heptanoate, 1g, supplied in an amber glass vial with tamper-evident seal and clear labeling for laboratory use.
    Shipping Oestradiol 17-Heptanoate is shipped in sealed, clearly labeled containers with secondary containment to prevent leaks. It must be transported at controlled room temperature, protected from light, and accompanied by appropriate safety documentation, adhering to all local, national, and international regulations for hazardous and pharmaceutical chemicals.
    Storage Oestradiol 17-Heptanoate should be stored in a cool, dry place away from light and moisture, at a temperature between 2°C and 8°C (refrigerated). The container must be tightly closed and clearly labeled. Keep the chemical away from incompatible substances and ensure it is handled by trained personnel, following all safety and regulatory guidelines.
    Application of Oestradiol 17-Heptanoate

    Applications of Oestradiol 17-Heptanoate in Industrial Manufacturing

    Oestradiol 17-Heptanoate serves as a key raw material in several specialized pharmaceutical and veterinary segments. As the direct manufacturer, we supply this compound to downstream formulators who require strict product consistency, validated regulatory pathways, and robust quality systems to support industrial scale production workflows and finished dosage formulation.

    1. Injectable Hormone Formulations for Human Hormone Replacement Therapy (HRT)

    Formulators utilize Oestradiol 17-Heptanoate in the production of long-acting injectable estrogen products for clinical HRT protocols. The compound’s extended release profile matches manufacturer demands for sustained plasma concentrations. Downstream producers must control esterification degree, solvent pre-treatment, and controlled filling under sterile production to ensure finished dose bioavailability and compliance. Consistency in batch QA and validated traceability are mandatory for supply into large-scale HRT product lines.

    Industry compliance standards

    • United States Pharmacopeia (USP) Monograph for Estradiol Valerate/Estradiol Esters
    • European Pharmacopoeia (Ph. Eur.) Section 01/2018:0452
    • FDA 21 CFR Part 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals)
    • ICH Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients

    Typical usage ratio

    • Dosage formulation: 1–10 mg/mL active ester in oil-based vehicles, varying by market registration and product specification.
    • Concentration adjusted according to local regulatory approved dosage strength and pharmacokinetic data.

    Downstream process integration

    • Direct dissolution in sterilized vehicle oils (e.g., castor, sesame oil).
    • Integration after micronization, followed by aseptic filtration and sterile vial filling.
    • Bulk lot homogeneity verification and release by pharmacy-grade QC analytical testing.

    Final product types

    • Intramuscular injectable ampoules for HRT
    • Pre-filled syringes for clinical hormone supplementation
    • Multi-dose vials for hospital and clinic supply chains

    2. Veterinary Hormone Preparations for Reproductive Management in Livestock

    Veterinary medicine manufacturers rely on Oestradiol 17-Heptanoate for formulating injectable hormonal solutions used in estrus synchronization and reproductive management programs. Downstream workflows require strict control of active ingredient concentration and solvent compatibility with species-specific delivery methods. Production lines must calibrate filling and vialing parameters to comply with veterinary pharmacopoeias and livestock administration protocols. The finished formulations support timed breeding cycles in commercial cattle and sheep operations.

    Industry compliance standards

    • VICH GL3 (Good Manufacturing Practice for Veterinary Medicinal Products)
    • European Pharmacopoeia Monograph 1497 for Veterinary Hormones
    • USDA Center for Veterinary Biologics requirements
    • Relevant local Ministry of Agriculture controls

    Typical usage ratio

    • Formulation range: 2–20 mg/mL in veterinary injectable solutions.
    • Dosage defined based on animal weight and program protocol by end-user veterinarian.

    Downstream process integration

    • Homogenization with stabilizers in jacketed mixing tanks.
    • Filtered transfer into sterile fill-finish lines equipped for veterinary vial formats.
    • Final product QC for content uniformity and endotoxin limits.

    Final product types

    • Estrus synchronization injectable vials for cattle and sheep
    • Veterinary hormone kits for reproductive cycle management
    • Multi-dose livestock reproductive hormone solutions

    3. Contraceptive Pharmaceutical Manufacturing (Depot Injectable Contraceptives)

    Pharmaceutical companies employ Oestradiol 17-Heptanoate in the assembly of depot contraception products. These formulations require extended in vivo release from biodegradable depot matrices or oil-based suspensions. Injectable contraceptive workflows utilize emulsification and micronization steps to obtain stable dispersed esters. Entire production runs operate under strict batch documentation and trace residue analysis to ensure dosage reliability and comply with worldwide contraceptive drug safety standards.

    Industry compliance standards

    • WHO Model List of Essential Medicines and quality guidelines
    • GMP as per PIC/S Guide to Good Manufacturing Practice for Medicinal Products
    • EMA/CHMP/QWP Guideline on Sterile Drug Products
    • National regulatory dossier requirements for contraceptive products

    Typical usage ratio

    • Product load: 5–30 mg/mL, depending on depot effect duration and market registration.
    • Adjusted per pharmacokinetic performance and clinical study outcomes for local approval.

    Downstream process integration

    • Micronization and wet-milling before emulsification.
    • Injection into sterile, particulate-free suspensions.
    • Aseptic filling into injectable containers or dual-chambered delivery devices.

    Final product types

    • Long-acting injectable contraceptive ampoules
    • Depo-suspension prefilled syringes
    • Depot microcrystalline suspensions for clinical contraception

    4. Reference Standard and Analytical Calibration Material Suppliers

    Chemical reference standard suppliers and quality control laboratories use Oestradiol 17-Heptanoate for the preparation of certified analytical standards, supporting validated assay methods in regulated pharmaceutical testing. Industrial standardization requires extremely pure, homogeneously distributed lots, often processed into unit-dose ampoules or sealed analytical vials. Downstream analytical workflows employ this material in calibration of LC-MS, GC-MS, or HPLC instruments for routine QC, product release, or method development in estrogenic compound assays.

    Industry compliance standards

    • ISO 17034:2016 (General requirements for the competence of reference material producers)
    • ISO/IEC 17025:2017 (Testing and calibration laboratories standards)
    • USP General Chapter <11> Reference Standards
    • European Pharmacopoeia General Notices for Reference Substances

    Typical usage ratio

    • Concentration adjusted as per analytical method requirements, often between 0.1–10 µg/mL for solution standards.
    • Final dilution prepared by downstream laboratory based on analytical validation needs.

    Downstream process integration

    • Accurate weighing and dissolution into HPLC or GC mobile-phase solvents.
    • Aliquoting into amber vials and sealing under inert gas (if necessary).
    • Homogeneity and stability checks before batch certification and distribution.

    Final product types

    • Certified analytical working and primary reference standards
    • Traceable calibration vials for assay method validation
    • Certified controls for pharmaceutical release testing
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    Certification & Compliance
    More Introduction

    Introducing Oestradiol 17-Heptanoate: Our Experience and Perspective

    Working With Oestradiol 17-Heptanoate: Bringing Chemistry to Practical Life

    At our site, Oestradiol 17-Heptanoate stands out not because of marketing, but because of long hours spent turning fine powders and liquids into chemicals that matter to researchers, formulation teams, and health professionals worldwide. The technical name offers a hint—this is a synthetic estrogen derivative, and each batch reminds us why careful adaptation pays off. We produce Oestradiol 17-Heptanoate with a defined model specification: it presents as a white or nearly white crystalline powder, melting above 140°C, and maintains purity above 99% by HPLC analysis. Our experienced technicians shepherd every lot through precise synthesis and rigorous purification, always on guard for any impurity levels or physical inconsistencies. The shelf life, critical to planning in every formulation lab, typically crosses two years if the product is kept protected from light and heat.

    Oestradiol 17-Heptanoate often gets grouped generically with other estrogen esters, but our chemists understand small changes in chemistry can bring substantial shifts in behavior—both in a reactor, a finished formulation, or the patient’s body. At the heart of this difference is the heptanoate chain, attached at the 17-beta position, which changes the absorption and metabolic profile when compared to shorter or longer side-chain esters like Oestradiol Valerate or Oestradiol Benzoate. With years spent refining our process, we see how subtle choices—reaction temperature, solvent system, crystallization timing—make all the difference in reducing by-products or boosting yield. This translates directly to more stable release profiles and more predictable pharmacokinetics, confirmed batch after batch with LC-MS and GC testing in our in-house laboratory.

    Why Oestradiol 17-Heptanoate Deserves Its Place: The Science We See Daily

    Synthetic estrogens find a home in various therapies. Oestradiol 17-Heptanoate, in particular, fits into depot preparations for long-acting hormone delivery. Many clinics and specialty manufacturers choose this ester for monthly injectable formulations. Our conversations with end-users—formulators, doctors, regulatory consultants—reveal why: the heptanoate chain slows down hydrolysis in tissue, supporting a slow, extended release of active Oestradiol. The result is less frequent injections and consistent hormone levels, which improves patient adherence for transgender hormone therapy, menopausal hormone replacement, and selected gynecological treatments.

    Other esters can offer shorter or longer action, and over the years we have produced them all. Compared with Oestradiol Benzoate, which gives a sharp spike and drop in blood concentrations, the heptanoate form smooths the curve, avoiding peaks that risk hormone-related side effects. Compared with Valerate and Cypionate analogues, the difference comes down to half-life and solubility. Some practitioners want monthly dosing—this is feasible with the heptanoate form, and less so with shorter chain esters. For veterinary use, long-acting injectables also simplify animal handling schedules, something our agricultural partners value highly.

    Daily handling of these molecules shows us how subtle changes shape performance. The crude product straight from the reaction vessel rarely meets the requirements. Oestradiol 17-Heptanoate works best free from residual solvents, showing sharp, singular diffraction peaks on XRD, and melting consistently within a one-degree window. Every particle-size analysis informs our micronization steps, since injectable suspensions demand tight dispersity for smooth operation in automatic filling machines. We track each deviation internally, knowing that an out-of-range result disrupts entire production schedules for our partners downstream.

    Navigating Complex Markets: Quality Expectations, Regulatory Demand, and Practical Matters

    Making Oestradiol 17-Heptanoate to this standard is not simply a technical feat. Over the past decade, regulatory demands have increased: agencies ask for robust impurity profiling, detailed stability studies, and thorough documentation of every raw material. Our core team, with backgrounds from compounding to chromatographic analysis, stays engaged with updates from USP, Ph. Eur., and ICH guidance documents. This requires far more than ticking checklists. We have embedded a process of continuous revalidation—pushing each batch past ordinary specification, archiving reference samples, and running parallel impurity studies to model worst-case scenarios.

    From contamination control to traceability, every operator in the plant knows why shoe covers matter, why sample handling protocols feel strict, why one unsafe shortcut can undo months of progress. On the documentation side, we field routine questions about elemental impurities and non-detected solvents. We learned long ago to run our own GC-MS screens for common concerns like benzene or 1,4-dioxane, even though synthesis routes don’t use them—better to supply hard data than assurances.

    Partners dealing with import controls, schedule regulation, and customs paperwork sometimes share their challenges. Customs officers want clear, legal documentation tied to the right CAS and HS codes. Pharmacovigilance teams request recent preservative-free status and excipient compatibility data. These are not burdens—they arise because trace issues risk patient safety and undermine faith in the system. The route from factory floor to patient is watched closely, and our willingness to preempt these concerns sets our Oestradiol 17-Heptanoate apart from material that comes by re-bagging or third-party aggregation.

    Process Insights: What Matters Most in Manufacturing

    The chemical pathway to Oestradiol 17-Heptanoate starts with high-purity estradiol, itself prepared by semi-synthesis from plant sterols or isolated from process streams in the fermentation of certain sterol-rich materials. The heptanoic acid involved must meet stringent specifications for water content and residual organic acids. In the reactor, an acid chloride intermediate forms before coupling to estradiol—a step requiring tight temperature and pH control, with real-time monitoring for possible overheating or off-spec side reactions.

    We have stopped production on more than one occasion to address small instrument drifts, which can cause transesterification or lead to altered impurity profiles. These are the details machines cannot catch alone. One of our senior operators once explained, “it smells different when the solvent runs wet, and you see cloudiness before the HPLC even confirms it.” This practical wisdom is shared during every training, which maintains the standard across years of turnover and new personnel.

    Crystallization and washing protocols came from months of trial, balancing the need for yield with the absolute need for a product free of residual acid or chloride byproducts. Even the filter paper chosen influences extractables in the final dry mass—a reality that emerges only after you see a failed dissolution test post-pilot batch. Product packed in inert nitrogen, with silica gel desiccants included and light-proof containers, reaches its destination with assured stability. Any protocol written in our plant reflects a dialogue between senior chemists, junior operators, analytical staff, and the compliance office—each sharing responsibility for the eventual use of each vial or drum.

    Differentiating Oestradiol Esters: Chemistry in Action

    As you compare Oestradiol 17-Heptanoate with other esters in the formulation palette, it helps to look at where they diverge not just chemically, but functionally. The length and branching of the acid moiety at the 17-beta position changes both the solubility in common vehicles—like ethyl oleate, castor oil, or isopropyl myristate—and the behavior after depot injection. For those seeking a balance between workable suspension, long-acting release, and manageable injection volumes, the heptanoate chain often represents the practical midpoint.

    Oestradiol Cypionate, for example, brings a long side chain and high oil solubility. It supports prolonged release, but can pose challenges with formulation viscosity and site irritation. Oestradiol Valerate, shorter in chain length, often works when faster onset is wanted, but wears off too quickly for certain therapies. We have spent years guiding partners through the technical literature and practical trial data—what solubilizers and preservative systems work best, what sterilization steps can affect molecular stability. Working alongside customers in their pilot plants led to insights that show up in our specification sheets: some batches serve best for oil-based injectables, others for lyophilized powder forms.

    Translating these differences into concrete outcomes means more than quoting pKa values or solubility coefficients. Patients on long-term HRT or clinics planning depot contraceptive cycles want to reduce variability between shots. Over the years, some customers reported that product sourced from secondary or tertiary suppliers seemed less consistent from vial to vial, leading to differences in clinical response or patient satisfaction. We trace this back to differences in production hygiene, quality assurance steps, and sometimes, lax packaging conditions ahead of international shipping. This feedback loop—factory floor experience, customer outcome, laboratory analysis—fuels the ongoing changes in how we approach each new production run.

    Taking Responsibility: Our Role in Reliability and Safe Supply

    The last few years, global supply chains taught everyone harsh lessons about risk. Relying on intermediaries for critical hormones left gaps when logistics broke down or regulatory oddities intervened. As a manufacturer who invests directly in every stage—from sourcing starting materials to validating the thermal profile of every batch—we believe people downstream deserve traceable, tested, and repeatable product. Regulatory teams from several continents request documentation we generate in-house: site master files, impurity mapping, full audit trails for every production lot. Over time, our paper trail and electronic records integrated to catch even small anomalies—a mismatch in raw material batch numbers, a missing signature on a log sheet, an unexplained temperature jump in a batch reactor.

    Packagers and secondary converters bring us new challenges, sometimes discovering aesthetic issues—particle settlement, color shift, or caking—that our stability chambers might not simulate in every conceivable shipping scenario. We collaborate on root-cause analysis instead of assigning blame. Sometimes the answer lies in extending nitrogen purging pre-packing, or specifying tighter controls on shipping temperatures. We take the call, investigate the underlying chemistry or process variable, and adapt our documentation and practice. For us, the goal remains the same: reliable, safe active ingredient for everyone from multinational pharmaceutical developers to specialty compounding pharmacies.

    Collaborative Problem-Solving in Hormone Manufacturing

    A key lesson from manufacturing Oestradiol 17-Heptanoate has been teamwork. Laboratories, production, regulatory, and shipping people each spot issues others miss. Quality issues sometimes emerge only after a product is finished and sent for formulation. An off-putting odor or unusual reactivity during final blending sometimes points to low-level contamination from an unfiltered solvent or a cleaning agent left behind. Each event starts a dialogue—sample return, parallel testing, method development for new impurity detection.

    We value input from customers experimenting with advanced delivery systems. Encapsulation and depot-forming injectables rely on tight control of particle properties. Large particle aggregates burst in needle injectors; too fine, and they suspend poorly. By gathering and analyzing real-world feedback, we tune our milling and drying steps for optimal performance in targeted applications.

    This process delivers a level of reliability that, in our experience, only comes from active, transparent partnership. We commit heavily to data sharing: every test result, every certificate, every deviation form. Some problems require fundamental chemistry changes—special purification or extra analytical steps—and others, tighter mechanical control on the plant floor. In the end, the difference plays out in the consistency and reassurance we deliver to the customer with every newly produced batch.

    Looking to the Future: Commitment to Quality, Safety, and Progress

    Chemical manufacturing rarely enjoys the limelight, yet the impact of reliability, transparency, and detailed craftsmanship resonates all the way to the patient. New trends in hormone therapy—rising use in transgender care, evolving approaches to menopausal treatment, shifting attitudes toward hormone use in veterinary and reproductive medicine—put greater emphasis on chemical substance quality and manufacturing integrity. Scientific literature expands every year, exploring questions of excipient compatibility, particle interaction, stability under diverse conditions, and the interaction of hormone molecules with modern delivery systems.

    Our approach reacts to and anticipates these trends. Each annual review, we invest in new analytical instruments, refine our internal documentation, and tune our training programs. We reference current guidance from agencies in Asia, Europe, and North America, participating in knowledge exchanges with academic researchers and regulatory specialists. By focusing on data, human experience, and transparent dialogue, we anchor our efforts where they matter most—reliable, safe chemical production. Oestradiol 17-Heptanoate remains a cornerstone in this journey: a well-characterized molecule, produced under attentive supervision, for use in therapies that make a difference.

    To the professionals who trust us with their formulations, to the researchers exploring new delivery systems, and to the caregivers seeking to improve outcomes for their patients, we commit to ongoing improvement and open cooperation. Manufacturing Oestradiol 17-Heptanoate is not simply a technical output—it carries responsibility, rooted in years of attention, shared knowledge, and honest collaboration. Our doors remain open for any inquiry, feedback, or technical challenge. As a team of chemists, operators, and analysts, we stand ready to adapt, grow, and stay at the forefront of this evolving field.