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Daunomycin

    • Product Name Daunomycin
    • Alias Daunorubicin
    • Einecs 205-508-9
    • 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
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    Specifications

    HS Code

    244722

    product_name Daunomycin
    synonyms Daunorubicin, Rubidomycin, Cerubidine
    CAS_number 20830-81-3
    molecular_formula C27H29NO10
    appearance Red crystalline powder
    solubility Soluble in water, methanol, DMSO
    mechanism_of_action Intercalates DNA, inhibiting macromolecular biosynthesis
    melting_point 211-215°C (decomposition)
    storage_conditions Store at 2-8°C, protected from light
    application Antineoplastic agent, used in chemotherapy
    origin Naturally produced by Streptomyces peucetius
    route_of_administration Intravenous

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

    Packing & Storage
    Packing Daunomycin is supplied in a 10 mg amber glass vial, sealed with a red cap and labeled with chemical details and hazard symbols.
    Shipping Daunomycin is shipped in tightly sealed, chemically-resistant containers compliant with hazardous material regulations. Packaging includes secondary containment to prevent leakage. It is transported at controlled room temperature and labeled according to international guidelines for dangerous goods. Proper documentation and handling instructions accompany all shipments to ensure safety and regulatory compliance.
    Storage Daunomycin should be stored in a tightly closed container, protected from light and moisture, and kept at a temperature of 2–8°C (refrigerated conditions). It should be handled in a well-ventilated area, avoiding exposure to incompatible substances and minimizing prolonged exposure. Strict adherence to institutional safety protocols is necessary to prevent contamination and ensure stability of the compound.
    Application of Daunomycin

    Applications of Daunomycin in Industrial Manufacturing

    Daunomycin serves critical roles in several specialized industrial and pharmaceutical sectors due to its anthracycline structure and antineoplastic properties. As an original manufacturer, we supply Daunomycin to regulated environments where strict compliance, targeted formulation, and controlled processing are essential. Below are the principal downstream applications organized by real-world industrial use cases.

    1. Active Pharmaceutical Ingredient (API) Manufacture for Oncology Injectables

    Daunomycin functions as a primary API in the production of antitumor injectable medications, particularly for hematological cancers. Pharmaceutical plants incorporate the raw material during aseptic manufacturing processes, emphasizing precise titration, solubility, and impurity control. The final injectables must comply with stringent release criteria for oncology treatments distributed to hospitals and clinical settings.

    Industry compliance standards

    • United States Pharmacopeia (USP) and European Pharmacopoeia (EP)
    • Chemical cGMP (current Good Manufacturing Practice, 21 CFR Parts 210/211)
    • ICH Q7A API GMP guidelines
    • EMA and FDA API site inspection requirements

    Typical usage ratio

    • API dosage ratios between 0.5% and 3% by weight in final injectable formulations, adjusted according to required therapeutic concentration and dilution protocols

    Downstream process integration

    • Introduced at the compounding stage, dissolved in sterile water or saline, filtered, and filled under closed isolator manufacturing lines, with in-process control for purity, solvent residues, and endotoxins

    Final product types

    • Lyophilized vials for hospital injection
    • Ready-to-use prefilled syringes
    • Large-volume parenteral bags (LVPs) for intravenous administration

    2. Formulation of Liposomal Chemotherapy Carriers

    High purity Daunomycin integrates into lipid vesicle carriers for the formulation of liposomal cytostatic drugs. In these advanced nanoparticle systems, pharmaceutical companies require granular control over active loading, encapsulation efficiency, and release kinetics to ensure targeted therapy with minimized systemic toxicity. The process uses solvent injection, hydration, and extrusion methods under sterile manufacturing and validation of particle size distribution.

    Industry compliance standards

    • ICH Q8 Pharmaceutical Development and Q9 Quality Risk Management
    • FDA Approved Drug Product (NDA/ANDA) Dossier Requirements
    • USP <797> Sterile Compounding Practice
    • ISO 14644 Cleanroom Standard for nanoparticle manufacturing

    Typical usage ratio

    • Encapsulated drug load typically ranges from 0.2% to 1.0% (w/v), determined by lipid-to-drug ratio and batch scale-up data; variable depending on targeted delivery profiles

    Downstream process integration

    • Loaded into the lipid phase during high-shear mixing; encapsulation step monitored for yield and residual free drug, followed by ultrafiltration and sterile filtration before aseptic filling

    Final product types

    • Liposomal injectable formulations for oncology departments
    • Single-dose ampules in cytostatic chemotherapy regimens

    3. Production of Antineoplastic Research Reagents

    Research reagent producers utilize pharmaceutical-grade Daunomycin for manufacturing cell biology kits, DNA-binding studies, and antitumor screening platforms. These reagents support preclinical drug discovery, mechanistic studies, and cytotoxicity analysis in both private and academic laboratories. The demand focuses on high analytical purity and batch traceability for reproducibility across global research programs.

    Industry compliance standards

    • ISO 9001:2015 Quality Management System
    • ISO 13485 for reagent supply in regulated laboratories
    • Material Safety Data Sheet (MSDS) and batch CoA traceability
    • OECD Good Laboratory Practice (GLP) certification where applicable

    Typical usage ratio

    • Custom reagent formulations between 0.01 mg/mL and 1.0 mg/mL, depending on cellular assay requirements; adjustment guided by in vitro concentration-response protocols

    Downstream process integration

    • Added directly during buffered formulation or lyophilization steps in research-grade kit manufacturing; aliquoted under controlled environments to prevent cross-contamination

    Final product types

    • Cell apoptosis assay reagent kits
    • DNA intercalator solutions for genome stability and cytometry applications
    • High-content screening libraries for antineoplastic compound screening

    4. Synthesis of Diagnostic Markers in Fluorescence Microscopy

    Biomedical companies employ Daunomycin as a fluorescent marker in specialized histological and cytochemical diagnostic assays. Its strong nucleic acid binding capacity, coupled with intrinsic red fluorescence, makes it valuable for clinical and research cytogenetics studies, including karyotyping and tumor marker imaging. Production emphasizes chemical conjugation and controlled labeling procedures to ensure signal specificity and stability.

    Industry compliance standards

    • ISO 13485:2016 for medical device and diagnostic reagent manufacture
    • IVD Directive 98/79/EC (where sold within the EU device sector)
    • Good Laboratory Practice (GLP) for life sciences
    • Comprehensive safety labeling per GHS and REACH

    Typical usage ratio

    • Marker loading from 0.05 µg/mL up to 2 µg/mL in final working solutions; final ratio determined by application sensitivity, substrate type, and imaging platform calibration

    Downstream process integration

    • Coupled to probe or carrier molecule during conjugation step; purified using liquid chromatography; formulated to preserve fluorescence stability and reduce photobleaching in final diagnostic kit

    Final product types

    • Fluorescence in situ hybridization (FISH) probes
    • Nucleic acid staining agents for microscopy
    • Diagnostic cytogenetics imaging reagents
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    Certification & Compliance
    More Introduction

    Daunomycin: Experience at the Source

    Our work with daunomycin began decades ago in response to the rising global demand for high-quality anthracycline antibiotics. This compound, recognized by researchers and clinicians for its ability to intercalate DNA, has helped shape an era of cancer treatment innovation. Reliability in every lot is an obligation, not a marketing point, for a manufacturer that understands what’s at stake with every shipment. Years of refining processes and updating controls have allowed us to deliver daunomycin far beyond laboratory scale without sacrificing purity or consistency.

    Daunomycin hydrochloride, sometimes listed as daunorubicin hydrochloride, arrives from our reactors as a tightly controlled crystalline powder, colored a distinct deep red. Our most common pharmaceutical grade product demands a purity of at least 98% by HPLC. Moisture content for our batches lands well below 3%. Any stray solvents vanish during drying, topped off by in-depth residual solvent testing. Tight particle size distribution carries over from synthesis through drying and milling, so the flow from our packaging room hits your specifications. We don’t lose sight of even a tenth of a percent variation, and every batch receives a full panel of microbiological and endotoxin checks. There’s little room for speculation—only tight readings and a lot of records.

    Across our facilities, our teams use fermentation and extraction methods informed by decades of global research and hard-won plant experience. Our starting materials and substrates arrive from verified suppliers, traceable to the field and lab. Every reactor run is tracked for key metrics: temperature, pH drift, agitation speed, nutrient uptake, and more. Post-reaction, we use organic solvent extraction and then fine-tune the crystallization process, chasing the narrowest impurity profiles possible. Modern filtration and lyophilization allow us to keep contaminants well below regulatory thresholds, often below detection on some of the strictest analytical instruments. Unlike traders, we see the raw material become active compound in real time, shaping outcomes tank by tank. Only in manufacturing can each step be traced, adjusted, and controlled down to the conditions of the hour.

    Applications that Matter

    Oncology professionals and clinical researchers rely on precise doses for their protocols, where even minor chemical variation leads to outsized effects. The predominant use for our daunomycin is in manufacturing injectable preparations for hospital and pharmacy use, especially for treating acute myeloid leukemia and certain lymphomas. Since these therapies expose every cell to the agent, any impurity or deviation carries real risk. For this reason, compounding pharmacists and clinical researchers look for transparent lot control, rapid documentation retrieval, and clear allergen-free processing statements. We meet these needs through validated cleaning protocols, allergen tracking, and chain-of-custody records for every shipment. Being the producer, not just a packer, means batches are never sourced on the open market; they can always be traced back to a real process, a real date, and a real person who watched the gauges.

    Outside human medicine, researchers in basic science and veterinary applications use daunomycin for cell viability studies, DNA tracking, and cytotoxicity screening. We have observed patterns: academic labs developing gene therapy models, plant science groups running apoptosis research, and pharmaceutical development teams running secondary testing for novel anti-cancer agents. These users expect clarity: absorption maxima, melting point, solubility at various pH, interactions with common buffers. Every catalog dose and every gram comes with years of method refinement, reference spectrum libraries, and a technical team that supports custom requests—not boilerplate answers.

    The Difference of Manufacturing Expertise

    Daunomycin from a direct manufacturer arrives with a history, not a batch number. This history stretches back from strain selection, fermentation controls, purification, to final testing. Traders may offer documentation, but they rarely understand why a batch failed a UV check, or how a minor change in agitation in week two of fermentation affects later re-crystallization. We train our staff on not just what measurements to take, but why small changes matter. We see how pH drifts on day twelve drive impurity profiles up, or how temperature swings in extraction raise risk of solvent retention. While third parties chase price swings and spot buys, we focus on backlog planning, storage stability, and transparent corrective actions.

    Pharmaceutical manufacturers invest in independent audits for a reason. In our facility, those auditors find redundancy in environmental controls, back-up power on lyophilizers, and line clearance to ensure zero cross-contamination. Our process validation files run hundreds of pages deep, reflecting every tweak and overhaul. Stability programs begin on Day One—not after a product recall or regulatory letter. Our animal facilities and handling protocols set the tone for everything else: no deviations tolerated, no shortcuts on biohazard containment, every sample kept under temperature log from release until use.

    Each comparison—be it a sample sourced from a non-manufacturing supplier or one purchased from a chemical trader—highlights the differences inherent in the source. Manufacturers understand why a one-degree fluctuation in drying temperature translates into microcrystalline defects, why every change gets tested, and why no documentation is “good enough” unless it matches process parameters. Documentation is not a task for us: it is the record of real, physical events in a plant run by real people. Batches follow the calendar of our facilities. Problems receive root-cause investigations with full transparency towards partners. Our client feedback speaks to this: research hospitals, cancer centers, national laboratories—many who have witnessed both sides understand what a real manufacturing batch means compared to a catalog listing or a repackaged lot.

    Sustainability without Lip Service

    Sourcing raw materials has changed over the years. Being a primary producer means we know the environmental toll, from antibiotic residues in rivers to energy demand during lyophilization. Our sustainability commitments stretch from land stewardship with fermentation substrates to waste solvent recovery. In our last expansion, we invested in closed-loop recovery for key solvents, achieved a measurable decrease in effluent toxicity, and shared our data with local authorities. Our supply chain partners sign contracts for traceability, require field audits, and accept surprise spot checks. Waste minimization happens at every step, not only because regulations require it, but because we run these facilities where our children live. Sustainability isn’t a marketing bullet for us; it’s a daily task tied to plant reliability, cost, and public trust.

    End-product testing feeds into a broader commitment: certified laboratories test for dioxin, heavy metals, and agricultural contaminants. If a batch falls short, it never leaves our door. Audit trails offer real-time proof—not just for regulators, but as risk management resources for the companies and hospitals counting on us. Sustainability extends to supply certainty; we maintain strategic reserves and keep multi-year maintenance cycles, so there’s no risk from a supplier folding or a major input missing. Our partners value uninterrupted access more than low prices or rushed shipping.

    Why Consistency Beats Cost

    Chemicals for research and clinical use force a simple truth: cost targets mean nothing when the material creates risk downstream. High variability in a raw daunomycin batch creates chaos for dosage formulation, shelf stability, or even basic reproducibility in clinical tests. Short-term savings in procurement can turn into multi-million-dollar delays if a supply is recalled, or worse, if contamination escapes and enters patient care. Our data show that professionals in the field value transparent release criteria, accurate trend monitoring, and live batch information, not just certificates with unreadable signatures from middlemen. Our plant teams take this as a challenge—every release is reviewed by people who can find and verify each step in the batch record.

    Direct manufacturers have another edge: flexibility. Our facilities adjust for customer demand in ways that third-party resellers struggle to match. Bulk lots, custom purity grades, tweaked water content, even optional carrier inclusion—these are not aftermarket add-ons for us; they are integrated into our production cycle and compliance plan. Because every gram is made in-house, the entire record, from receiving strain banks to final vial sealing, is available. Our regulatory teams understand both the constraints and the opportunities; their suggestions lead to years of continuous improvement, not just a box-ticking exercise for the next agency visit.

    Any user—chemist, pharmacist, regulator—who has run into irregularity on an ingredient knows the downstream headaches. We avoid those problems at the source by integrating real-time monitoring at every stage, maintaining redundant systems, and giving every team member agency in process adjustments. Our success isn’t just the result of experience, but of a willingness to learn from every deviation, no matter how small. Our legacy partners understand: stable sourcing comes from more than contracts; it comes from demonstrated diligence, technical investment, and pride in visible results.

    Safety, Training, and Support

    Products like daunomycin demand training and respect. It is a potent cytotoxin, capable of harm with even accidental skin contact or improper handling. We don’t treat safety as a checkmark; we engrain it into every step, from handling raw extracts to shipping labeled vials. Our production floor uses sealed systems, HEPA-filtered air, and mandatory decontamination for all processing spaces. Full PPE—goggles, masks, lab coats—stays on until the packaging is sealed and sterilized. Our QA and safety officers conduct unannounced drills, backed by real-time environmental data and external audits. Frontline staff know not only what to do, but why it matters.

    Support doesn’t end at shipment. Our technical team fields urgent queries on solubility, batch compatibility, and lab handling protocols. Researchers facing an unexpected quality control result have real experts to talk to, not a generic help desk. Years of internal technical sharing mean our personnel know more about our process than any distributor or trader. If a laboratory faces an outlier result or a temperature excursion in storage, we assist with root-cause analysis and replacement material. This hands-on approach builds lasting partnerships with everyone from junior PhDs to seasoned oncologists. Feedback forms roll straight to our operations teams—not through layers of sales management—so plant improvements match real-world needs.

    Product Portfolio and Future Innovation

    Our core daunomycin line extends from standard crystalline powder through ready-to-use vial formulations, all produced under strict cGMP conditions. Newer additions reflect evolving need: modified salt forms for improved solubility, research-scale solutions for rapid screening programs, and stability-tested reference standards for near-lab deployment. Veterinary applications prompted new formulation sizes and sterility testing. This flexibility owes everything to in-house expertise; from media selection in fermentation to last-mile cold-chain logistics, our teams accept every challenge as a problem to solve, not a hurdle to avoid.

    Innovation stems from necessity, not fashion. Our R&D teams monitor new literature, exploring fermentation media optimization, lower-waste purification, and approaches to secondary metabolite recovery. Every change must pass not only laboratory review but also pilot production, stability, and full toxicological review. Being the origin, we see changes ripple through cost, reliability, and compliance, so every experiment is documented, trialed, and—if it works—locked into SOPs for the plant. We collaborate closely with customers whose new products need unique purity levels, blending, or co-formulation support. Our portfolio reflects what the world demands, not only what sells easiest.

    Real Responsiveness: Not Buzzwords

    Many suppliers promise “service” or “flexibility,” but these are only real if the product comes from your hand, not a catalog. We run extra labs tests on request, supply real process documentation, and welcome in-person audits—not because regulators require it, but because we have nothing to hide. Some clients request historical impurity trends, stability projections, or expired batch data; we provide these because real manufacturing means having this information available, not cobbling it together after the fact. If the industry changes a monograph, if a compound is found to have a new impurity risk, we adjust process controls overnight, not after a quarterly review.

    Pharmacy buyers, R&D directors, and even procurement specialists know the difference: emails answered by chemists, not sales reps, root cause analyses without runaround, and shipments that never miss a temperature spec. Our partners have toured the plant, watched batches run, and talked directly to the production leads. This directness fosters ongoing trust and improvement, whether for a small pilot run, or routine monthly delivery for national-scale compounding.

    The Value of Primary Manufacturing

    Our role as the original manufacturer gives unparalleled insight. We see every shipment as a promise: quality, traceability, and reliability. Sourcing direct isn’t about cost alone—it is about risk mitigation. No relay race of unknown handlers, no surprises three warehouses down the chain. Documentation can be pulled and checked, not just faxed or digitized. Auditing is more than a permission; it is an expectation. Our doors remain open to qualified partners whose own diligence matches ours.

    We have been at the meeting table for process deviation reviews, recall responses, and regulatory audits. This experience teaches the value of humility, preparation, and continuous improvement. Collaborations with leading clinics, universities, and industry giants push us to share what works and disclose what doesn’t. The value of manufacturing comes down to this: put quality and accountability ahead of convenience, and every partner—no matter the size of their order—gets material that stands up to scrutiny. Our facility and our record speak to this priority.

    Conclusion: Why Daunomycin from a Manufacturer Sets the Standard

    The daunomycin we manufacture reflects the work, knowledge, and care of our teams over years of experience. Our standards rise from satisfying the strictest requirements in clinical and research science. Real-time process control, inflexible quality management, and safety systems designed by those who understand the compound’s risks all shape each batch. This is not commodity trading; it is skilled production at its most critical. End-users—whether solving a life-or-death clinical challenge or researching an edge case in cell biology—require nothing less.

    Our commitment to improvement never stops. As the original source, we drive change in process efficiency, environmental responsibility, and technical support. Each kilo, each gram, carries our reputation—earned through plant-floor experience, not marketing. That’s the difference you find when you turn to the true manufacturers: visible expertise, accountability, and a product line that meets the letter and the spirit of the highest standards.