Tengfei Creation Center,55 Jiangjun Avenue, Jiangning District,Nanjing admin@sinochem-nanjing.com 3389378665@qq.com
Follow us:

Gestrinone

    • Product Name Gestrinone
    • Alias Geslutin
    • Einecs 254-290-7
    • 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

    158835

    Name Gestrinone
    Chemical Formula C21H24O2
    Molecular Weight 308.41 g/mol
    Drug Class Steroidal progestin
    Usage Treatment of endometriosis
    Administration Route Oral
    Bioavailability Variable
    Half Life 27.6 hours
    Protein Binding High
    Metabolism Hepatic
    Elimination Route Renal
    Synonyms R2323, SH-9400
    Atc Code G03DB04
    Legal Status Prescription only
    Cas Number 16320-04-0

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

    Packing & Storage
    Packing Gestrinone is packaged in a white, sealed vial containing 500 mg of fine powder, labeled with product details and handling instructions.
    Shipping Gestrinone is shipped in tightly sealed, clearly labeled containers to prevent contamination and ensure stability. It is transported under controlled temperature conditions, typically at room temperature and protected from light. All packaging complies with regulatory guidelines for pharmaceuticals and hazardous chemicals, ensuring both safety and product integrity during transit.
    Storage Gestrinone should be stored in a tightly closed container, protected from light and moisture. Keep at room temperature, ideally between 15°C and 30°C (59°F–86°F). Store in a dry, well-ventilated area away from incompatible substances, such as strong oxidizers. Ensure access is restricted to authorized personnel and follow all relevant safety guidelines and regulations for handling pharmaceuticals.
    Application of Gestrinone

    Applications of Gestrinone in Industrial Manufacturing

    As the original manufacturer supplying Gestrinone as an active pharmaceutical ingredient (API), we focus on partnership with downstream enterprises engaged in regulated pharmaceutical production. Our material enters only verified, compliant industrial processes, aligning with global requirements for drug substance quality, traceability, and finished medicinal products. This section details the principal industrial application fields for Gestrinone, outlining essential compliance protocols, material dosing guidance, downstream production methodology, and ultimate dosage form categories.

    1. Progestogen Component in Oral Contraceptive Tablet Formulation

    Pharmaceutical formulators incorporate Gestrinone as the progestogenic agent within certain specialized oral contraceptive regimens intended for niche reproductive health scenarios. Tablet-manufacturing processes require precise control of active dosing and compatibility with additional excipients to ensure tablet uniformity, bioavailability, and stable shelf-life, while adhering strictly to reproductive health medication monographs and safety profiles. Continuous validation occurs during large-scale blending, granulation, compression, and finished product QC to meet both regulatory and in-market requirements for hormonal contraceptive drugs.

    Industry compliance standards

    • WHO Prequalification of Medicines Programme
    • ICH Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients
    • European Pharmacopoeia (Ph. Eur.) Monographs
    • China Pharmacopoeia (ChP) or United States Pharmacopeia (USP), as applicable
    • National Drug Regulatory Authority (NMPA, EMA, FDA) registration specifications

    Typical usage ratio

    • 0.5 mg–5 mg per tablet (exact content calibrated per registered contraceptive formulation, population guidelines, and established dosing studies)

    Downstream process integration

    • Directly weighed and introduced into wet granulation or direct compression blend; subject to in-process assay and blend uniformity
    • Integrated before primary tablet pressing and subjected to multiple checkpoints during bulk and finished product release

    Final product types

    • Blister-packed oral contraceptive tablets
    • Single-phase and multiphasic combined hormone pill packs for regulated prescription use

    2. Active Pharmaceutical Ingredient for Endometriosis Therapy

    Gestrinone serves as the API in prescription capsule and tablet therapies for endometriosis management, produced by certified pharmaceutical manufacturers. Strict control at the API-to-formulation interface ensures consistent active content throughout batches, preclinical stability, and safe metabolic profile for prolonged administration. Packing lines carry out secondary packaging and serial tracking for supply chain integrity in compliance with GMP and patient safety protocols.

    Industry compliance standards

    • EU Directive 2001/83/EC on Medicinal Products for Human Use
    • Good Manufacturing Practice (GMP) - PIC/S GMP Guide
    • Active Substance Master File (ASMF/DMF) protocols
    • EMA/FDA Endometriosis Therapy Guideline adherence

    Typical usage ratio

    • Ranges between 1.25 mg and 5 mg per unit dose (final ratio optimized in downstream formulation trials and clinical substantiation, targeting daily/biweekly protocols)

    Downstream process integration

    • Bulk API dispensed into high-shear mixers with excipient library for capsule or coated tablet manufacture
    • Introduced early in the closed-system filling process, followed by encapsulation or tableting, in-process controls, and serial packing

    Final product types

    • Prescription capsules for hospital and pharmacy channel supply
    • Coated or uncoated tablets for domestic and export markets

    3. Hormonal Agent for Benign Breast Disorder Treatment

    Gynecological product lines utilize Gestrinone as a precisely dosed hormonal agent in oral therapies managing benign breast conditions (e.g., fibrocystic breast disorders). Regulatory workflows demand full documentation of source API validation, traceability throughout batch processing, and real-time monitoring of hormone blending and unit dosage accuracy at every production step to satisfy stringent medical device-drug combination protocols where applicable.

    Industry compliance standards

    • Good Manufacturing Practice (GMP) per national agencies (e.g., CFDA, EMA, FDA)
    • Relevant pharmacopoeial monographs for hormonal actives
    • Medical Device-Drug Combination Product Quality System Regulation (QSR, 21 CFR Part 4 where registered as combination product)
    • Relevant pharmacovigilance legislative frameworks

    Typical usage ratio

    • 1.25 mg–2.5 mg per unit dosage form (selected according to product registration, clinical guidelines, and tolerability studies)

    Downstream process integration

    • Introduced into pre-blend excipient matrix for hormonal tablet or soft capsule formation
    • Applied to controlled environment processing to avoid cross-contamination and hormonal residue carry-over

    Final product types

    • Dose-specific oral tablets labeled for benign breast disorder management
    • Hospital and clinic-distributed soft gelatin capsules with validated stability

    4. Reference Material in Pharmaceutical Analytical Laboratories

    Certified pharmaceutical quality control laboratories use highly purified Gestrinone as a reference standard for identity, impurity profiling, and quantitative analysis in development, validation, and release testing of related finished dosage forms. Standard operating procedures, instrument calibration, and data traceability underpin all analytical runs, which underpin dossier submission and batch release for regulated pharmaceutical markets.

    Industry compliance standards

    • International Conference on Harmonisation (ICH) Q2 and Q6A guidelines
    • ISO/IEC 17025 Laboratory Accreditation
    • Pharmacopoeial reference standard protocols (USP, Ph. Eur., ChP)
    • 21 CFR Part 211 (Good Laboratory Practice)

    Typical usage ratio

    • Preparation of reference solutions: usually in microgram per milliliter concentrations (0.1–10 μg/mL standard curves; precise amount dictated by analytical method validation requirements)

    Downstream process integration

    • Dissolved into validated diluents to prepare calibration curves for HPLC, LC-MS, and related assays
    • Employed in each batch analysis cycle for quantitative and qualitative drug product release

    Final product types

    • Analytical reference standards for QC laboratories
    • Standard curves and test solutions for regulatory submission dossiers
    Free Quote

    Competitive Gestrinone prices that fit your budget—flexible terms and customized quotes for every order.

    For samples, pricing, or more information, please call us at +8615371019725 or mail to admin@sinochem-nanjing.com.

    We will respond to you as soon as possible.

    Tel: +8615371019725

    Email: admin@sinochem-nanjing.com

    Get Free Quote of Sinochem Nanjing Corporation

    Flexible payment, competitive price, premium service - Inquire now!

    Certification & Compliance
    More Introduction

    Introducing Gestrinone: Crafted by Those Who Know the Chemistry

    Getting to the Heart of Gestrinone

    From years of hands-on work in the synthesis and refinement of steroidal compounds, our team understands what sets real quality apart. Whenever a conversation shifts to Gestrinone, its role as a synthetic steroid with antiprogestational and androgenic properties always comes forward. People have relied on it in gynecological applications, especially for managing endometriosis. We have invested in the right manufacturing approaches to keep the material consistent and reliable, batch after batch.

    Working with Reliable R&D Means Better Product Consistency

    Over the years, our process engineers have faced countless challenges—from scaling up pilot batches to controlling unwanted byproducts. Each step toward improving the synthetic route for Gestrinone has been guided by real-world feedback from pharmacists and clinicians. Strict process controls, analytical testing, and process analytical technology give us a product with high assay purity and reproducible behavior in formulation.

    Our typical offering has Gestrinone as a crystalline powder, off-white to pale yellow. Specifications align with requirements for pharmaceutical compounding, but years of manufacturing have taught us that focusing solely on numbers leaves out the reality of how the material behaves on the production floor. Variations in solubility or flowability can disrupt an otherwise smooth tableting process. Our team works relentlessly to minimize polymorphic variability by controlling temperature, solvent conditions, and crystallization times.

    Getting the Chemistry Right

    Gestrinone’s chemical identity—17α-Ethynyl-18-methyl-19-nor-Δ9,11-testosterone—brings together features that challenge most synthetic chemists. The ethynyl and methyl groups are not only structurally important but also sensitive to conditions in the reactor. Overheating or over-oxidation during synthesis destroys the potency or yields unwanted impurities. Our staff has solved those issues by refining the timing of addition and optimizing catalyst loadings for the best balance of throughput and cleanliness.

    One of the most overlooked aspects in steroid production involves keeping trace contaminants in check. Even a small amount of high-polarity side products can affect dissolution characteristics—something our quality control lab tracks with both high-performance liquid chromatography and mass spectrometry. This level of monitoring requires in-house expertise and long-term investment in analytical infrastructure, which allows us to confidently stand behind our published assay results.

    Application Insight: Clinical Relevance Without Guesswork

    Gestrinone finds use mostly in the treatment of endometriosis—a condition that disrupts the lives of millions. Standards for drug raw materials remain unforgiving, and rightly so. We recognize how unpredictable the final formulated medication can become if the starting ingredient’s properties vary across shipments. That’s why we regularly communicate with formulating pharmacists to understand their pain points in blending and dispersing the product.

    In compounding facilities, poor powder flow or unpredictable agglomeration causes material loss or unsteady dosing. Unlike traders who only see test sheets, our direct experience lets us tailor drying, particle sizing, and packaging based on practical, on-site needs. Every decision stems from years of feedback. For these reasons, clinics and institutional buyers have come to expect a material that behaves consistently in excipient blends or capsule fillings.

    Understanding What Sets Gestrinone Apart

    Many active pharmaceutical ingredients (APIs) compete for a similar therapeutic space, but the peculiarities of Gestrinone—both in synthesis and pharmacology—set it apart. Unlike danazol or some progestins, Gestrinone does not only exert antigonadotropic effects; it also brings partial androgenicity and weak gluco-thyroid activity to the table. These features create a distinct benefit in certain cases, particularly when other hormones spark unwanted side effects.

    In comparing Gestrinone with alternatives like danazol or mifepristone, it becomes clear: optimization of side chain architecture yields differences in receptor selectivity and half-life. Gestrinone strikes a delicate middle ground in activity, which can help reduce certain adverse reactions. Of course, every molecule comes with its own limitations. Absorption, metabolic stability, and ease of formulation all hinge on how it is produced. Years spent refining particle size and bulk density have meant fewer surprises in the hands of our downstream partners.

    Why Upstream Quality Matters More Than Ever

    Long-term reliability does not come about by chance. The pharmaceutical world has seen market shocks when overseas suppliers drop out or an unexpected impurity renders stock unsellable. The real work for us begins far upstream, with the sourcing of precursor steroids. Our vertical integration ensures traceability for every lot, with no reliance on outside brokers. Chemical synthesis of Gestrinone draws on years of process know-how, from the right choice of protecting groups to the timing of oxidation.

    In the lab, it’s the small adjustments that often make the difference between a batch that meets specification and one that ends up discarded. Our operators know the quirks of each reactor and have learned to spot subtle signs—changes in color, crystal habit, or odor—that point to problems before they hit the final testing stage. These minor interventions reduce delays and prevent downstream headaches for our customers.

    Supporting Responsible Product Development

    Earning trust in the research and medical communities means more than passing a set of lab tests. Our interactions with the regulatory landscape stretch back decades. We work with industry standards—both regional and global—because patient safety and real-world reliability matter deeply to us. Unlike products that bounce from trader to trader with little accountability, our Gestrinone comes backed by documentation, traceability, and a clear custodial chain.

    Each release undergoes repeated reviews and audits. Regulatory requirements change, sometimes with little warning, but our team adapts fast, drawing on relationships with regulators and updated analytical protocols. This constant improvement extends to our environmental practices. We have cut solvent usage and developed recycling strategies to minimize emissions, which supports both compliance and long-term sustainability.

    Why Clients Notice the Difference

    Feedback from compounding pharmacies and developers flows straight to our technical group, fueling new improvements in every campaign. Some years back, a key client highlighted recurring problems with dustiness during transfer. Instead of brushing off the complaint, we retrofitted our sieving line and adjusted milling parameters. That effort led to a more manageable product that reduced product loss and improved worker safety.

    Another client, in the middle of a critical supply crunch, benefited from our willingness to hold buffer stock for their high-priority projects. Not every manufacturer can offer that degree of flexibility, and certainly no broker can troubleshoot at the process level. Keeping technical support close and responsive offers a measure of reliability our clients depend on—not just for the end product, but for every step along the way.

    Troubleshooting: What We’ve Learned from the Hard Batches

    Not every manufacturing run goes smoothly. Our worst batches have been our best teachers. Small impurities undetected by older testing methods prompted us to invest in faster, more sensitive instrumentation. On one occasion, an undissolved gum caused uneven crystallization and an out-of-spec particle profile. Our chemists, rather than blaming raw materials, went back through every step, isolated the cause, and implemented a new protocol for solvent verification.

    Much of what makes a high-quality Gestrinone comes down to responsiveness and institutional memory. We keep detailed logs for every deviation, feeding data back into our continuous improvement cycle. Lessons learned here then become the baseline for future production campaigns—not only for Gestrinone but for other complex APIs in our pipeline.

    Honest Risk Talk: Managing the Hazards

    Any company that manufactures steroids contends with risks—occupational, environmental, and reputational. Gestrinone is no exception. Our facility employs advanced containment and air-handling methods, not simply out of obligation but out of respect for our own workforce. Over the years, measuring surface residues and tracking air quality inside the plant have led us to invest in better personal protective equipment and housekeeping. These steps keep our production areas cleaner, our staff healthier, and our products less likely to pick up unwanted cross-contamination.

    Waste management forms another ongoing concern. Outdated methods of solvent disposal would not pass muster today. Instead, we separate and regenerate solvents wherever possible. This not only saves resources but supports a more circular production model that the next generation of chemists can build upon.

    Real-World Performance for Real-World Use

    It can be easy to focus only on lab specifications—purity, loss on drying, metals content, and so on. Those numbers matter, but years in chemical manufacturing teach another lesson: processability and supply predictability keep production lines moving in the real world. We have cultivated relationships with users that share feedback about compounding challenges, dissolution behavior, or even regulatory hurdles. That knowledge lets us make timely adjustments, realigning our process set points or modifying particle size for better dispersion in end use.

    This responsiveness, matched with robust quality oversight, offers formulators fewer interruptions and a product that does not behave unpredictably. In practice, these details mean hospitals can stock up without fear of delayed shipments, compounding pharmacies avoid sudden sourcing headaches, and ultimately, patients receive the therapies they count on as planned.

    The Differences Come Down to How It’s Made

    Over a decade of Gestrinone manufacturing has shown us one consistent truth: product differences appear both on paper and on the plant floor. Others may claim comparable purity, but they often lack the systems and accountability that mark our approach. Every lot receives scrutiny from synthesis through final release. The subtle distinctions arise from the design of the synthetic route, the management of processing variables, and the willingness to reinvest into better technology.

    It is not only about who has the newest equipment, but who cares enough to adapt that equipment to the problem at hand. Our production crew, supported by scientists and operators with years of combined experience, keep their standards high because their reputation depends on it. In the final analysis, that dedication stands behind every shipment of Gestrinone that we put into the world.

    Looking Forward: Building on a Tradition of Expertise

    Anyone can offer technical brochures and audited laboratory reports. What matters in the long run is the knowledge gained through years of persistent production, adaptation, and honest communication with users. Our commitment to Gestrinone is not the result of a one-off project, but part of a broader tradition of producing specialty steroids for the global healthcare market.

    Trends in medicine will continue to evolve, forcing manufacturers to update their processes, rethink their environmental footprints, and tighten their documentation. That challenge suits us. The ongoing investment in new analytical methods, training, and sustainable production underscores our pledge to those who depend on our products—not just today but for years to come.

    Final Thoughts on Quality and Partnership

    Real value in chemical manufacturing lies beyond simple certificates. Longevity in this industry requires trust earned through each batch shipped and every challenge met. Gestrinone, refined across countless campaigns, represents the kind of quality and reliability that comes only from putting in the years, listening to clients, and never settling for good enough.

    The lessons gained here translate across our entire operation, strengthening not only our products, but also the confidence that users place in our name. At its core, Gestrinone’s difference lives not in abstract marketing terms but in the lived expertise of those who produce it, track it, test it, and stand behind it every step of the way.