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Tianeptine

    • Product Name Tianeptine
    • Alias Stablon
    • Einecs 210-771-4
    • 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

    921518

    Chemical Name Tianeptine
    Cas Number 66981-73-5
    Molecular Formula C21H25ClN2O4S
    Molecular Weight 436.95 g/mol
    Drug Class Atypical antidepressant
    Mechanism Of Action Modulates glutamatergic activity and serotonin reuptake
    Route Of Administration Oral
    Approved Use Treatment of major depressive disorder (MDD)
    Half Life 2.5 to 3 hours
    Legal Status Prescription-only in some countries; controlled in others
    Brand Names Stablon, Coaxil, Tatinol
    Side Effects Drowsiness, dry mouth, constipation, dizziness
    Excretion Primarily renal
    Protein Binding Approximately 94%
    Origin France

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

    Packing & Storage
    Packing White plastic bottle labeled "Tianeptine, 100 capsules, 12.5mg each"; safety-sealed, with hazard warnings and batch/expiry information.
    Shipping Tianeptine is shipped in secure, tamper-evident packaging, compliant with relevant regulations. It is typically transported in sealed containers to protect against moisture, light, and contamination. Documentation includes material safety data sheets and shipping manifests. Special handling and labeling are required due to its classification and potential regulatory restrictions in certain regions.
    Storage Tianeptine should be stored in a tightly sealed container, protected from light, moisture, and heat. Store at room temperature, ideally between 15°C and 25°C (59°F–77°F). Keep away from incompatible substances and out of reach of unauthorized persons. Ensure proper labeling and follow local regulations for storage and handling to maintain its stability and prevent degradation.
    Application of Tianeptine

    Applications of Tianeptine in Industrial Manufacturing

    As a specialized manufacturer, we supply Tianeptine as a chemical raw material to a select group of regulated downstream industries where its unique properties are essential for finished product formulation. Our Tianeptine meets consistently high standards to support reliable incorporation into advanced production workflows. Below, we detail its principal industrial applications, with specific compliance, formulation, process, and end-use information for each sector.

    1. Pharmaceutical Tablet and Capsule Production

    In the pharmaceutical sector, Tianeptine functions as the primary active pharmaceutical ingredient (API) in manufacturing prescription drugs for mood disorders and depression. API delivery requires precisely controlled blending, compaction, and coating processes to meet dosage accuracy, stability, and dissolution requirements mandated by health authorities worldwide. Here, Tianeptine integrates into wet or dry granulation lines and automated tablet or capsule filling machinery, with close consideration for traceability and batch uniformity.

    Industry compliance standards

    • Current Good Manufacturing Practice (cGMP, 21 CFR Parts 210 & 211, FDA)
    • International Council for Harmonisation (ICH) Q7 Guideline
    • European Pharmacopoeia (Ph. Eur.) Monographs
    • U.S. Pharmacopeia–National Formulary (USP-NF)

    Typical usage ratio

    • Ranges from 10 mg to 37.5 mg per oral unit; adjusted per market authorization and formulation target strength

    Downstream process integration

    • Direct introduction during the dry or wet granulation phase; blending with excipients before compression or encapsulation; inclusion in batch records for validation and QC sampling

    Final product types

    • Film-coated tablets
    • Hard-gelatin capsules
    • Extended-release oral dosage forms

    2. Bulk Powder Formulation for Compounding Pharmacies

    Licensed bulk powder facilities and hospital compounding pharmacies rely on industrial-grade Tianeptine to produce individualized prescriptions and clinical research samples. Strict labeling, weighing, and aliquoting protocols apply to ensure safety and documentation throughout manual or semi-automatic batch preparations. Each lot must show conformity with regulatory pharmacopeia standards, and pharmacists adjust add-back ratios to physician-prescribed dosages on a case-by-case basis.

    Industry compliance standards

    • United States Pharmacopeia Chapter <795> (Pharmaceutical Compounding – Nonsterile Preparations)
    • Drug Enforcement Administration (DEA) recordkeeping (where scheduled)
    • Compounding Quality Act (503A and 503B, U.S. FDA)
    • Relevant country-specific pharmacopoeias and health ministry directives

    Typical usage ratio

    • 10–25 mg per customized dose, with concentration tailored to patient origin and prescription requirements

    Downstream process integration

    • Precision dispensing and blending with excipients at the on-site compounding station; batch aliquoting and packaging in controlled cleanroom environments

    Final product types

    • Unit-dose sachets
    • Bulk oral powder bottles
    • Custom batch capsules/blends

    3. Active Substance for Prescription Effervescent Tablets

    Industrial manufacturers use Tianeptine as a functional active in the production of effervescent tablets intended for rapid dissolution and easy oral administration. Production requires careful control of moisture, pH, and mechanical mixing to prevent pre-reaction and ensure stability during high-speed tablet compression and packaging. Producers achieve precise API dispersal for consistent release profiles and must validate residual moisture and active content for every lot.

    Industry compliance standards

    • European Medicines Agency (EMA) GMP (Directive 2003/94/EC)
    • Good Manufacturing Practice for Pharmaceutical Products (PIC/S Guide to GMP)
    • International Organization for Standardization (ISO) 9001:2015 (Quality Management Systems – optional but widely adopted)
    • Official local pharmacopeia monographs

    Typical usage ratio

    • 10–25 mg per effervescent unit; adjusted for foaming agent compatibility and formulation volume

    Downstream process integration

    • Blended into the dry phase after moisture testing; batch mixing completed just prior to tableting; inclusion in in-process control tests for uniformity and degradant screening

    Final product types

    • Perforated blister-packed effervescent tablets
    • Tube-pack effervescent tablets

    4. Principal API in Research-Grade Substance Supply

    Universities, CROs, and licensed laboratory suppliers purchase high-purity Tianeptine for validated preclinical research, assay development, and analytical method calibration. Batch traceability, identity testing, and impurity profiling standards must meet rigorous scientific and ethical protocols. Researchers tailor solution strengths or solid-state forms according to study requirements, with mass accuracy and batch integrity strictly documented at every step.

    Industry compliance standards

    • ISO 17025 (General Requirements for the Competence of Testing and Calibration Laboratories)
    • GLP (Good Laboratory Practice, OECD and FDA)
    • Research-use-only (RUO) labeling and traceability systems
    • Country-specific chemical control and import/export permits

    Typical usage ratio

    • Stock solutions typically at 1–10 mg/mL for in vitro work; solid-state aliquots provided per specified protocol, usually 5–50 mg per test

    Downstream process integration

    • Direct weighing and dissolution in analytical solvents; preparation for cell-based assays or in vivo dosing; inclusion in control/standard-run protocols

    Final product types

    • CRM (Certified Reference Material) vials
    • Analytical laboratory reagents
    • Preclinical research kits
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    Certification & Compliance
    More Introduction

    Tianeptine – An Introduction from the Manufacturer’s Perspective

    Understanding Tianeptine

    Manufacturing Tianeptine goes beyond simply combining ingredients in a reactor. Years of handling the synthesis, purification, and process optimization have taught us how every variable influences the product’s consistency. Tianeptine, with its chemical structure centered around sodium salt formation, comes as a fine, white to off-white powder. Its molecular integrity allows for precise formulation in both pharmaceutical and research settings. We supply Tianeptine in its sodium salt form, not because it is a trend, but because, through decades of practical feedback and rigorous quality assurance, this form repeatedly ensures physical stability, accurate measurements, and fast dissolution rates. Tablets, capsules, and compounded solutions benefit directly from these physical properties.

    Chemically, Tianeptine sodium (CAS 30123-17-2) belongs to tricyclic compounds, but it acts substantially different from classic antidepressants. This is not only a matter of literature but also observed during analytical batch checks and end-user reports. Each lot starts as a careful selection of raw materials, only progressing to synthesis once all incoming materials pass strict purity benchmarks. After multi-stage purification, our in-house HPLC and NMR capabilities confirm that each batch matches the claimed technical specification, without residual solvents or interfering byproducts. End-users report a product that is free-flowing, low in moisture, and easy to weigh—details that can only emerge when routine lab analysis meets real, hands-on experience with the final material.

    Performance Factors That Matter

    Customers often ask about differences between Tianeptine sodium, Tianeptine free acid, and other analogues. From a manufacturer’s standpoint, the sodium salt’s solubility and storage stability stand out. Humidity in a production facility or warehouse can encourage clumping, especially with poorly processed powders, so the strict drying parameters in our process contribute directly to the uniformity that customers notice. We find the sodium salt handles much better during formulation, whether for compounding pharmacies or pilot pharmacology studies. This wasn’t a theoretical decision but comes from batches that stayed stable in high-humidity regions and shipped across long distances without degradation.

    Going through kilo-scale batches, we learned the subtle differences in how a well-processed sodium salt resists yellowing and degradation. Quality control doesn’t stop at the HPLC chromatogram. Visual inspection, particle size measurement, and actual reconstitution in neutral solutions catch issues that don’t show up during single-point purity checks. These details ultimately separate a manufacturer’s product from a repackaged commodity. We've seen returns drop and repeat orders climb as these hands-on improvements make daily use much simpler and more predictable for formulators and researchers alike.

    Why Model and Specification Matter in Tianeptine

    Model numbers sound abstract until they tie to real world consistency and traceability. Each lot of Tianeptine sodium produced under our protocols carries a specific internal batch and model identifier. At first glance, customers see a simple code. In reality, it connects to a batch record tracing every step from raw chemical supplier to final packaging—an unbroken documentation chain for identification, root cause analysis, or regulatory review. Lot-to-lot consistency only emerges when production batches run under defined conditions, using validated procedures and regularly recalibrated analytical instruments. Skipping these steps risks introducing subtle impurities that might not register until formulation begins.

    On paper, Tianeptine sodium's listed specification includes details like assay, water content, heavy metals, and residual solvent content—typically confirmed by validated methods such as Karl Fischer titration and ICP-MS. This isn’t checkbox compliance. Discussions with pharmacologists and formulation chemists regularly highlight how these measured parameters affect stability and application in final dosage forms. For example, high residual moisture can affect tablet compaction and shelf life, especially in climates with large temperature swings. Our focus remains on controlling these values batch-after-batch, continually revisiting our procedures based on feedback rather than theoretical guidelines alone.

    Learnings from Routine Practice

    We often field questions about purity claims and real-world usability. Practical manufacturing has shown us that purity is only one part of the story. The ease of weighing, minimal dust generation, non-caking storage, and predictable dissolution rates matter just as much once the material arrives at the customer’s facility. These attributes do not result from random chance but steady process refinement—small changes in crystallization time, drying temperature, or grinding technique that seem minor, but collectively shape the product's day-to-day reliability.

    Routine feedback from customers and rigorous in-house testing led us to set internal standards above the minimum required for regulatory compliance. Every year, we review anonymous user feedback, stability data, and third-party analysis to verify that our approach actually improves outcomes in formulation and research. Batches flagged for any off-odor, color change, or visible contamination undergo full investigation and do not leave our facility until cleared. We keep records on every deviation, using those lessons to harden future releases against recurrence.

    How Tianeptine Compares with Similar Products

    Our team has handled a range of tricyclic products and related substances during process development and contract synthesis. Many share similar core chemistry, but Tianeptine’s behavior during purification and storage has always proven unique. Its solubility profile means filtration and drying have to be timed with unusual precision. Small deviations cause significant differences in appearance and stability. Direct experience with these quirks lets us identify subtle indicators of a well-made batch—traits like non-hygroscopicity and resistance to physical change after days in sub-optimal storage conditions. We learned these by keeping control samples from years past and observing their evolution, not just through certificates but firsthand inspection.

    Analogs such as Tianeptine free acid and Tianeptine sulfate each require specific handling. The sodium salt remains the most widely requested because of its ease of use in a variety of applications, including oral, parenteral, and compounded research products. Our own pharmaceutical partners and small batch users frequently request the sodium version for its consistent performance in both simple and complex formulations. Where the free acid and sulfate forms exhibit limitations with solubility or stability, sodium salt routinely outperforms, as confirmed by both customer applications and extensive internal benchmarks. Customers benefit from this clarity, and their purchasing decisions reflect real-world tested performance rather than theoretical claims.

    Practical Experience with Process and Delivery

    Supplying Tianeptine in volume means more than shipping parcels. Packing, transport, and regulatory documentation all matter. Over the years, we built logistics around typical but critical bottlenecks: humidity control, light protection, and minimizing transport time. Mistakes in these areas are costly, teaching us to specify multilayer packaging, minimize time outside the desiccator, and use validated couriers experienced with chemicals sensitive to temperature and vibration. We’ve documented entire shipments, tracking outlier incidents like packaging tears and freight delays, then updated SOPs to address these. When customers open a bottle and see a bright, free-flowing powder months after production, that comes from hard-earned process improvements—not a lucky break.

    We also document the impact of routine handling on packaging choices and shelf-life claims. Our technical staff reviews long-term storage samples quarterly to catch and measure any batch drifting out of specification. This hands-on vigilance protects end-users from the disappointment of off-spec shipments and builds the trust required in a direct manufacturer relationship. The same mindset drives our commitment to clear label information—real batch numbers, production and expiry dates, and storage conditions developed from real-life stress testing instead of assumptions.

    Why Direct Manufacturer Input Improves Tianeptine Quality

    Decisions made during synthesis, purification, and packaging do not emerge from abstract planning or remote corporate directives; they result from real-world lessons at each step. As a manufacturer, we encounter problems firsthand and, through thorough root cause investigation, devise practical workarounds. Each new scale-up or contract job often brings unforeseen hurdles with solubility, filter clogging, or stability. Instead of downplaying these, we document, adjust, and refine our process for all subsequent runs.

    Direct oversight of every aspect—from sourcing raw precursors to bottling and inspection—builds institutional knowledge that shapes our operation. Site visits, hands-on sampling, and after-service follow-up tell us where not to cut corners. For instance, relying on outside contract labs for release testing seldom delivers timely and actionable results. Internalizing all quality checks, even at added cost, gives us greater control and faster turnaround, which customers often notice. Manufacturers get called in when problems arise, so we maintain a technical staff that not only checks paperwork but knows how to troubleshoot equipment and address supply chain snags.

    Feedback Loop from Users and Industry Developments

    We encourage feedback from pharmaceutical companies, university researchers, and compounding pharmacists using our Tianeptine. The good, the bad, and the frustrating all inform our next improvement cycle. Preferably, these conversations happen before a minor issue becomes a real setback for a customer project. User feedback prompted us to add desiccant packs, redesign caps for moisture protection, and invest in tighter particle size controls. If the same question arises more than once in a year, we incorporate it into our next batch review session.

    Staying current with worldwide regulatory changes and industry best practices means that our Tianeptine reflects not just internal experience, but external developments too. Updates to pharmacopoeial standards, changes in allowable heavy metal content, and even shifts in permitted solvents propel upgrades in our process. We attend industry meetings and participate in relevant consortiums not as a public relations gesture, but because these technical exchanges provide insights often missing from solitary research. These connections have helped us anticipate issues that others spot only too late.

    Improving the Supply Chain and Traceability

    Direct control over our own supply chain remains critical. We learned that trusted suppliers often offer more predictability than the lowest bidder. Each material shipment comes with documentation and undergoes identity testing upon arrival. We rotate raw stock in a manner that aligns with manufacturing scheduling and expiration windows, removing the risk of aged or compromised ingredients entering the process. Full chain-of-custody records from incoming materials to outgoing shipments create traceability, which has paid off whenever an issue with a raw lot or external audit arises.

    We do not outsource responsibilities that are central to performance. In the event of a disruption or quality incident, in-house response teams mobilize immediately, leveraging both digital records and process know-how. For all Tianeptine shipments, customers can request batch documentation that tracks each stage of material handling—a routine in our operation that increases transparency and fulfills external audit requirements. These records are routinely updated and available upon request for all qualified customers with legitimate needs.

    Product Safety and Compliance from a Production Viewpoint

    Our understanding of safety and compliance comes from repeated internal inspections and outside agency audits. Equipment calibration, environmental monitoring, and operator certification are staples in our workflow. For Tianeptine, special attention goes to airborne contamination controls and precise weighing technology. Operators receive routine retraining, focusing on both safety and technical competence. Documentation trails capture actions taken during every stage, meeting both customer and regulatory requirements without unnecessary bureaucracy.

    Each new regulatory update, whether in local markets or international jurisdictions, sees our technical staff reevaluating the compliance baseline. For instance, as certain solvents encounter new limits for residual presence, we revalidate purge and testing methodologies, documenting these for both certificate and internal use. Collecting and responding to these changes keeps product safety at the forefront and allows rapid adaptation when customers request new certifications or formatting.

    Lessons Learned, Problems Solved, and Future Directions

    Problems encountered during years manufacturing Tianeptine often present opportunities for improvement. Past incidents with residual impurity spikes led to an overhaul of our analytical methods, swapping out less sensitive techniques for precision LC-MS. User complaints about caking in high humidity drove upgrades to drying and packaging steps. These fixes were not hypothetical—they emerged only through regular, hands-on engagement with the products we supply.

    Looking ahead, process automation and expanded in-house analytical capabilities are on the horizon. Upgrading to higher-throughput synthesis reactors will improve batch reproducibility and allow for tighter process control, further minimizing batch-to-batch variation. Implementing multi-site data collection across our facilities will help spot patterns and pre-empt difficulties before they develop. Continued investment in training and technology lets us deliver a product tuned, not just for current expectations, but for the evolving demands of pharmaceutical and research communities.

    Summary of Manufacturer’s Commitment

    As a direct producer of Tianeptine, we work with more than checklists and compliance statements. Each step in our process reflects continuous input from real customers, evolving regulatory standards, and our own technical experience at the frontline of chemical production. Our approach prioritizes stability, purity, and reliable performance, keeping our product trusted across diverse applications. Improvements remain on-going, driven by feedback, on-the-ground learning, and a commitment to better results with every batch that leaves our doors.