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Trazodone Hydrochloride

    • Product Name Trazodone Hydrochloride
    • Alias Desyrel
    • Einecs 247-161-3
    • 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

    828413

    Generic Name Trazodone Hydrochloride
    Brand Names Desyrel, Oleptro
    Drug Class Antidepressant
    Dosage Forms Tablet
    Primary Use Major depressive disorder
    Mechanism Of Action Serotonin antagonist and reuptake inhibitor (SARI)
    Route Of Administration Oral
    Common Side Effects Drowsiness, dizziness, dry mouth
    Controlled Substance No
    Prescription Status Prescription only
    Typical Adult Dose Range 150-400 mg per day
    Half Life 5 to 13 hours
    Pregnancy Category Category C
    Storage Requirements Store at 20°C to 25°C (68°F to 77°F)
    Fda Approval Year 1981

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

    Packing & Storage
    Packing The packaging for Trazodone Hydrochloride contains 100 tablets in a white, child-resistant plastic bottle with a sealed tamper-evident cap.
    Shipping Trazodone Hydrochloride should be shipped in tightly sealed, clearly labeled containers, protected from light and moisture. It must comply with all local and international regulations for pharmaceutical transport. The package should include appropriate documentation and be handled to avoid contamination or physical damage, maintaining an ambient or specified temperature as required.
    Storage Trazodone Hydrochloride should be stored at controlled room temperature, ideally between 20°C to 25°C (68°F to 77°F). Keep it in a tightly closed, light-resistant container, away from moisture, heat, and direct sunlight. Store the medication out of reach of children and pets, and do not use beyond the expiration date printed on the packaging.
    Application of Trazodone Hydrochloride

    Applications of Trazodone Hydrochloride in Industrial Manufacturing

    Trazodone Hydrochloride serves as a specialized pharmaceutical intermediate for advanced industrial applications. As a manufacturer, we optimize its production to meet diverse processing needs in regulated sectors, ensuring compliance and consistent supply for high-value downstream manufacturing. Below are key industrial application segments, detailing real-world integration, compliance standards, formulation ratios, and end product types.

    1. Active Pharmaceutical Ingredient (API) Synthesis for Antidepressants

    Major pharmaceutical producers utilize Trazodone Hydrochloride as the core active moiety in the manufacture of prescription antidepressant tablets and capsules. Our product is introduced following stringent validation to support bulk drug formulation lines, specifically under cGMP protocols. Industrial blending requires close control on input ratios based on targeted dosages prescribed under regulatory guidelines. Each batch undergoes systematic QC and traceability from raw material authentication to final formulation. The entire process, from wet granulation to tablet compaction and film-coating, integrates the material at defined blending and reaction steps to ensure uniformity and compliance with finished product standards.

    Industry compliance standards

    • ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
    • European Pharmacopoeia Monograph 07/2017:1798
    • United States Pharmacopeia (USP) <1798>
    • EDQM Certificate of Suitability (CEP) where required

    Typical usage ratio

    • 50 mg to 300 mg per unit dose, with industrial blending targeting 10%–45% API ratio relative to excipient mixture, depending on final tablet strength
    • Adjustment based on prescribed dosage forms and market registration requirements

    Downstream process integration

    • Incorporation after API verification during dry or wet granulation
    • Final blending prior to compaction, followed by film-coating and packaging
    • Finished product testing for content uniformity and dissolution profile

    Final product types

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

    2. Contract Formulation Manufacturing (CDMO) for Generic Medicines

    Contract development and manufacturing organizations apply Trazodone Hydrochloride in the production of generic versions of antidepressant formulations approved for multiple international markets. Our material supports high-throughput batch lines, requiring precise input and cross-contamination controls. API handling involves direct transfer into closed mixing systems with validation of cleaning procedures and real-time in-process checks to confirm conformity with dossier submissions. Multinational contract projects rely on consistent intermediate quality to comply with country-specific regulatory files and supply chain traceability for batch release.

    Industry compliance standards

    • WHO Good Manufacturing Practices for Pharmaceutical Products
    • FDA 21 CFR Part 210/211 (cGMP for finished pharmaceuticals)
    • PIC/S GMP Guidelines
    • Relevant country-specific generic drug regulations (e.g., EMA, ANVISA)

    Typical usage ratio

    • API input at 10.0%–30.0% w/w in bulk blend, subject to regional dosage form requirements
    • Ratio defined by client dossier and finished product regulatory submission

    Downstream process integration

    • Automated raw material dispensing via closed-loop system
    • Blending with excipients using high-shear mixers
    • Quality sampling at blend, compression, and pre-packaging stages

    Final product types

    • Generic antidepressant tablets
    • Unbranded prescription capsules
    • Direct-to-market private label antidepressants

    3. Research and Development of Slow-Release Psychiatric Drug Delivery Systems

    Industrial R&D units and scale-up laboratories incorporate Trazodone Hydrochloride into prototype sustained-release and extended-release matrix formulations targeting neurological drug delivery. The raw material feeds into experimental granulation, coating, and extrusion processes during pilot batch runs, supporting experimental adjustments for dissolution kinetics and pharmacokinetic profiling. The research setting requires close attention to solubility modification, particle size control, and robust analytics against evolving international release standards for novel dosage forms.

    Industry compliance standards

    • ICH Q8(Quality by Design) and Q9 (Risk Management) guidelines
    • FDA Guidance for Industry: Extended Release Oral Dosage Forms
    • EU GMP Annex 13 (for investigational medicinal products)
    • OECD Principles of Good Laboratory Practice (GLP, where relevant)

    Typical usage ratio

    • API at 15%–35% of matrix system, with concentration optimized for desired release profile
    • Pilot batches typically 1–5 kg scale for formulation screening

    Downstream process integration

    • Integration to matrix blend or multiparticulate system
    • Hot-melt extrusion or fluid-bed coating during process scale-up
    • Comprehensive in vitro dissolution testing and stability runs

    Final product types

    • Experimental extended-release tablets
    • Sustained-release multiparticulates
    • Clinical trial batches for psychiatric drug studies

    4. Veterinary Pharmaceutical Formulation for Animal Mental Health

    Pet pharmaceutical manufacturers and animal health companies use Trazodone Hydrochloride as an ingredient in veterinary formulations designed to manage anxiety and behavioral disorders in companion animals. Material integration follows animal-specific pharmacokinetic guidelines, with careful scaling of active substance to body weight and safety profiles. Processing includes microencapsulation for palatability and accurate dosing, as well as low-temperature blending to avoid API degradation. Regulatory filings demand species-specific studies and batch documentation from API origin through finished product release.

    Industry compliance standards

    • VICH GL9 Good Manufacturing Practice for Veterinary Medicinal Products
    • FDA Guidance for Industry: CVM Veterinary Drug Manufacturing
    • European Medicines Agency (EMA) Veterinary Medicines Regulations
    • National veterinary formularies and compendia licensing

    Typical usage ratio

    • 1.0–5.0 mg per kg animal body weight per dose, blended at 3%–10% active ratio in pet chew, liquid suspensions, or tablets
    • Precision depends on targeted animal species and final product format

    Downstream process integration

    • Pre-mixing into flavor-masked animal dosage formulations
    • Microencapsulation and tableting under controlled temperature and humidity
    • Finished product stability testing under veterinary guidelines

    Final product types

    • Veterinary oral tablets and chews
    • Liquid oral suspensions for pets
    • Customized prescription blends for companion animals
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    Certification & Compliance
    More Introduction

    Trazodone Hydrochloride: Practical Perspectives from Our Production Line

    Building Consistency with Trazodone Hydrochloride

    In our day-to-day operations, few compounds have attracted as much technical focus as Trazodone Hydrochloride. Our factory floor sees it move from raw ingredients to finished active pharmaceutical ingredient, and what drives our attention is always consistency—every single batch lined up with the specs our partners expect and regulatory agencies inspect. We recognize that a single deviation in purity or particle size can disrupt complex pharmaceutical preparation; this keeps production standards high and attention close at every stage.

    We process Trazodone Hydrochloride with an eye for the details that matter most for oral solid dosage manufacturers. In our facility, the product commonly leaves as either a fine white or off-white crystalline powder, ready for blending into tablet or capsule forms. Particle size distribution sits tightly within the range most tableting machines handle best—typically centered at D50 values between 65–110 microns, but with quality control checks ensuring minimal fines or oversized granules. This kind of physical property control keeps in-process blending even and prevents segregation, especially during automated tableting.

    Specifications and Real-World Quality Control

    We choose to focus on producing Trazodone Hydrochloride at a purity level that stands out in analytical testing—frequently above 99.0% by HPLC, with tightly limited related substances. This matters because once the ingredient hits downstream processing, impurities and side-products can cause trouble with dissolution rates or even show up in stability data. So, our QC teams run not just compendial methods but also in-house assays that push detection beyond the standard thresholds. With every batch, we prioritize detectable levels of N-oxide, impurity A, impurity B, and several residual solvents to ensure that nothing slips through, especially when scale-up batches are destined for commercial launch products.

    In moisture-sensitive formulations, excessive water can tip the balance. We keep loss on drying below 0.5%. Few tablets tolerate more, especially in high-speed runs where uniform drug content is critical. For end users blending Trazodone Hydrochloride, high-batch reproducibility isn’t a feather in the cap, it’s the price of entry into contract manufacturing. Each release certificate that leaves our plant is signed by a senior chemist, reflecting hands-on review rather than a tick-box on a spreadsheet.

    Model Variations and Application-Specific Adjustments

    Our experience tells us that demand isn’t uniform across all customers or global regions. In some settings, a micronized grade of Trazodone Hydrochloride offers better compression profiles for direct compression tableting, especially where lower dose strengths are called for. For others, a standard crystalline grade handles large-scale wet granulation smoothly, aiding in content uniformity when actives represent under 5% of the formulation blend.

    A project for a film-coated formulation asked us to address bulk density, as the existing process led to capping issues on the press. In response, our technical staff worked with R&D partners to adjust drying conditions and milling steps, shifting untapped density closer to 0.45 g/cm³ without introducing excessive fines. These sorts of batch-specific tweaks come from direct feedback on the line, not from an abstract specification sheet. Most customers bring their own pill presses, granulators, and R&D quirks, so a one-size-fits-all mindset does little good. We believe in practical customization grounded in real facility feedback, bridging the gap between manufacturing and the realities of finished dose production.

    Usage Perspectives from Industry Experience

    Trazodone Hydrochloride holds its place in a variety of oral psychiatric medications. Over the years, our production teams have encountered formulation teams wrestling with its sometimes-challenging flow properties, especially when building fixed-dose combinations. We’ve responded with process adjustments at the manufacturing stage, such as enhanced sieving and selective granulation steps, to tame caking and improve processability. Some teams working with high-shear mixers report better blend uniformity by pairing our powder with inert excipients known for binding out moisture and reducing static; so, we share these operational tips freely, having tested and validated them ourselves.

    In sustained-release formulas, fine control over granule size and compressibility shifts from a nice-to-have to mission-critical. The compounding pharmacists with whom we've cooperated have shown that subpar grades yield tablets that fracture or dust out during coating. We’ve incorporated feedback on friability and friable tablet edges, pushing our material towards the mechanical specs that prevent such failures.

    How Our Trazodone Hydrochloride Stands Apart

    From the inside of a chemical plant, it’s easy to spot generalizations that don’t hold water in practice. Some will say all APIs are interchangeable if they meet compendial requirements, but the granular view tells us otherwise. Our Trazodone Hydrochloride has been selected by major generic and specialty pharma firms not only due to certificates and audit checklists but also because of hands-on trials in their plants, showing it behaves as anticipated in production volumes—not just bench-scale testing.

    Beyond the molecule itself, the integrity of supply has proven nearly as important as any technical spec. Multinational companies running clinical studies, or scaling up for country-specific launches, have counted on us for clear documentation and batch-to-batch bona fides that survive the scrutiny of site inspections or import audits. We maintain traceability not as a box-ticking exercise but out of recognition that every recall, delay, or deviation can mean real cost, lost contracts, or jeopardized launches.

    Global pharma supply lines learned hard lessons during travel restrictions and logistic disruptions. Holding full GMP compliance and long-standing consistency made it possible for several partners to pivot quickly with us—often receiving customized documentation, stability data, or rapid process approvals, without ever fearing an undocumented change or untraceable batch. Our role stretches beyond molecule synthesis: we keep analytical sample archives, document all process adjustments, and field rapid questions from QA departments around the globe.

    Comparisons to Other Product Sources

    Not every Trazodone Hydrochloride supply chain can offer layering of technical, regulatory, and service standards in the same way. We frequently see inquiries from companies who experienced poor experiences with variable supply from poorly-audited sources—batches out of spec, unexpected delays, or a lack of transparency about production origins and critical process parameters. These firms often pay the price in investigations, nonconformances, or regulatory findings that can topple whole product lines.

    Choosing a route through more informal market channels can sometimes seem attractive on a price-per-kilogram basis, but it brings unknowns—compendial compliance does not guarantee that every batch will run through tablet presses or capsules without glitches. We have engaged with quality heads who encountered weak powder flow, solvent carryover, or sudden color variance from alternate suppliers, with direct impact on manufacturing output and product stability. These are not textbook concerns; they are day-to-day issues that separate a reliable API manufacturer from a transactional intermediary.

    Market feedback consistently highlights that regulatory support and audit transparency matter just as much as physical specs. Our regular engagement with global authorities, documentation of data integrity, and clear chain of custody allow customers to pass audits smoothly and respond promptly when regulators raise questions. We see this as central to our offering.

    Lessons Learned from Real-World Manufacturing

    Over decades of producing Trazodone Hydrochloride, we’ve experienced the gamut of technical, regulatory, and supply chain pressures that shape today’s pharma environment. We push to eliminate variability from every step, from raw starting material all the way through final packaging. Multi-stage purification, robust in-process monitoring, and redundant QC cross-checks stand not as window dressing but as the backbone of uninterrupted, compliant supply.

    Scaling up production for global partners often means adapting to the evolving standards set by both originator and generic drug manufacturers—demands for stricter impurity thresholds, better physical stability, or tighter microbial counts. Our technical teams work alongside customer process engineers to troubleshoot challenges uncommon on the bench but regular on full-scale lines: for instance, minimizing static charge during powder transfer, optimizing flow through pneumatic transfer systems, or adjusting solubility profiles to fit different regional manufacturing preferences.

    Training and continuous improvement form a cornerstone of our strategy. Process engineers and QC staff examine historical deviation records and emerging industry guidance, then run internal tests to validate any process adjustments. Each significant change undergoes risk analysis and customer notification, bridging the gap between continuous improvement and regulatory stability. This dialogue has helped mitigate downstream surprises and smoothed new product introductions.

    Supporting Partners Beyond the Molecule

    It’s easy to focus on numbers and analysis, but behind the certificates and specs, we partner with teams who face tight commercial launches, challenging regulatory submissions, and competitive market pressures. Supporting these teams means more than dispatching drums of API—it includes detailed, customizable documentation, rapid sample dispatch for sizing studies, and answering technical questions on the spot during critical qualification phases.

    Global regulations continue to tighten, so we maintain flexible, up-to-date data packages ready for new submissions—from full DMFs to granular impurity tables. Our regulatory affairs group interfaces routinely with several major health authorities, responding to deficiency letters or supplying missing data directly from original manufacturing records. Keeping direct lines of communication—engineer to engineer, chemist to chemist—lets us understand what works on the line, not just in the lab report.

    Looking ahead, our commitment to clean, supply-transparent, and traceable production grows only stronger. We watch not only shifts in global demand but also in compliance expectations and environmental stewardship. Our wastewater treatment and solvent recycling serve as daily reminders that good manufacturing means balancing high output with responsibility.

    Trazodone Hydrochloride and the Reality of Quality Manufacturing

    We have learned that quality is never static. Each project brings new requirements, stricter regulatory frameworks, or more demanding process controls. Our direct experience producing Trazodone Hydrochloride underlines that it’s not the certificates or data points alone that matter but the ability to deliver batches that run smoothly in global production plants, pass every regulatory inspection, and carry through from clinical stage to retail launch.

    Factories don’t operate in isolation; every decision we make—whether it’s upgrading a filtration step, adopting new analytical technology, or shifting drying conditions—ripples outward to customers, their patients, and their regulatory partners. With Trazodone Hydrochloride, as with so many APIs, being a dependable partner in production, issue resolution, and regulatory navigation sets the true measure of a quality manufacturer.

    This commitment, built up batch by batch and partnership by partnership, has guided us for years. We keep advancing—upgrading, retraining, listening closely—so that our Trazodone Hydrochloride isn’t just a chemical on a certificate but a reliable choice for companies, patients, and regulators the world over.