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Hydroxyurea

    • Product Name Hydroxyurea
    • Alias hydroxycarbamide
    • Einecs 201-598-3
    • 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

    883873

    generic_name Hydroxyurea
    brand_names Hydrea, Droxia, Siklos
    drug_class Antineoplastic agent
    chemical_formula CH4N2O2
    molecular_weight 76.05 g/mol
    route_of_administration Oral
    indications Chronic myeloid leukemia, sickle cell anemia, head and neck cancers
    mechanism_of_action Inhibits ribonucleotide reductase, interfering with DNA synthesis
    dosage_form Capsule, tablet
    common_side_effects Bone marrow suppression, nausea, vomiting, diarrhea, skin ulcers
    pregnancy_category D
    storage_conditions Store at room temperature, away from moisture and heat

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

    Packing & Storage
    Packing Hydroxyurea is packaged in a white, sealed HDPE bottle containing 100 grams, labeled with hazard warnings, batch number, and manufacturer's details.
    Shipping Hydroxyurea should be shipped in compliance with all applicable regulations. It must be securely packaged in tight, labeled containers, protected from moisture and light. Transport under ambient temperature is typically sufficient, but ensure no exposure to extreme temperatures. Appropriate documentation, material safety data sheets (MSDS), and hazard labeling are required during shipping.
    Storage Hydroxyurea should be stored in a tightly closed container at room temperature, ideally between 20–25°C (68–77°F), away from light and moisture. It should be kept in a dry, well-ventilated area, separate from incompatible substances. Access should be restricted to authorized personnel, and storage areas must be clearly labeled and secure to prevent accidental exposure or ingestion.
    Application of Hydroxyurea

    Applications of Hydroxyurea in Industrial Manufacturing

    As a pharmaceutical-grade chemical manufacturer, we supply hydroxyurea to various specialized industries worldwide. Below we outline distinct, field-proven application scenarios and technical integration details in commercial-scale manufacturing environments.

    1. Oncology Formulation in Pharmaceutical Production

    Hydroxyurea is a critical API in oral oncology medicines, particularly for managing chronic myelogenous leukemia and certain solid tumors. Downstream pharmaceutical partners require stringent documentation and batch consistency, ensuring the substance meets precise pharmacopeial profiles. Hydroxyurea is blended during finished dosage form production, with the exact dose tailored to therapeutic protocols and formulation factors, influencing the composition of tablets or capsules distributed internationally under regulated conditions.

    Industry compliance standards

    • USP, EP, JP, and IP pharmacopoeial specifications (Active Pharmaceutical Ingredient regulations)
    • Current Good Manufacturing Practice (cGMP, 21 CFR Parts 210 & 211)
    • ICH Q7: Good Manufacturing Practice for Active Pharmaceutical Ingredients
    • EMA and FDA Drug Master File (DMF) submissions

    Typical usage ratio

    • Active concentration in tablets or capsules: 400–1000 mg per unit dose; adjusted to formulation size and target patient regimen

    Downstream process integration

    • Weighing and micronization for direct blend or wet granulation in oral solid dose lines
    • Integration with excipient matrix in fluid-bed or high-shear granulation units
    • Compaction, encapsulation, and in-process QC for dosage uniformity
    • Packing in HDPE bottles or blister strips under controlled conditions

    Final product types

    • Hydroxyurea 500 mg tablets (generic oncology drugs)
    • Pharmaceutical capsules for cytostatic therapies
    • Pediatric oral suspensions for specific hematologic diseases

    2. Sickle Cell Disease Therapy Manufacturing

    Major biopharma producers rely on hydroxyurea as the main therapeutic agent in products for sickle cell anemia management. This application mandates exacting controls against genotoxic impurities and consistent release parameters. Manufacturing partners utilize validated, closed system processes during formulation to safeguard operator safety, with detailed batch recordkeeping for traceability and regulatory submission. Dosing regimens must accurately deliver the intended therapeutic benefit, with minor composition tweaks for pediatric or adult therapies.

    Industry compliance standards

    • WHO Model List of Essential Medicines compliance
    • Strict adherence to US FDA and European Medicines Agency (EMA) bioequivalence requirements
    • GMP manufacturing and validation per ICH Q8 and Q9
    • Labeling and packaging per CFR 201 and 211 for cytotoxic medications

    Typical usage ratio

    • Dosage 15–35 mg/kg/day calculated per patient weight, incorporated into immediate-release tablets or capsules

    Downstream process integration

    • Clean room blending of API with excipients under negative pressure hoods
    • Wet or dry granulation, using closed barrier systems
    • Compression, tablet coating, and stability chamber testing
    • Quality control: dissolution, content uniformity, and cytostatic safety assays

    Final product types

    • Hydroxyurea tablets for sickle cell disease in multiple regulatory markets
    • Oncology-grade capsules for hemoglobinopathy treatment
    • Pediatric oral suspensions in pre-measured bottles or sachets

    3. Chemical Intermediate for Urea Derivative Synthesis

    Hydroxyurea serves as a targeted intermediate in the large-scale synthesis of specialized urea derivatives, including semicarbazide and aminoguanidine. These secondary products fulfill downstream roles in photo-stabilizer, pharmaceutical, and fine-chemical blend manufacturing. Large-volume users require consistent hydroxyurea purity for process reliability, and integrate it during specific reaction phases in closed reactors, precisely adjusting input quantities according to mole-based calculations that influence the ultimate product yield and downstream application properties.

    Industry compliance standards

    • ISO 9001:2015 Quality Management System for fine chemical manufacturing
    • REACH registration and reporting in EU supply chains
    • Hazardous chemical control per OSHA 29 CFR 1910.1200
    • Customer-specific acceptance criteria for impurity profile

    Typical usage ratio

    • Theoretical stoichiometric input: typically 1.0–1.1 molar equivalence per downstream target compound, adjusted by desired final yield and purity

    Downstream process integration

    • Metered charging into jacketed stirred tank reactors, controlled by automated dosing and pH/temperature regulation
    • Intermediate work-up in liquid-liquid extraction, followed by isolation and purifications steps
    • Filtration and recrystallization in multi-stage batch or continuous chemical plants
    • Final QA analytical verification for residual hydroxyurea content

    Final product types

    • Semicarbazide hydrochloride for pharmaceutical and photographic applications
    • Aminoguanidine derivatives for specialty chemical and agrochemical intermediates
    • Stabilizers and modifiers for advanced resin systems

    4. Starting Material in Laboratory-Scale Custom Synthesis

    Research-oriented chemical companies and contract development manufacturers procure hydroxyurea as a core building block in exploratory or pilot-scale synthesis of novel organic molecules. Labs implement meticulous quality assurance to avoid contamination in high-purity applications. Usage quantities, batch sizing, and dissolution protocols differ greatly by project, with procurement specifications centered on analytical purity and consistency, facilitating fast-track R&D for pharmaceutical or diagnostic research.

    Industry compliance standards

    • ISO/IEC 17025 accreditation for analytical and research laboratories
    • GLP (Good Laboratory Practice) standards for experimental use
    • Local regulatory authority permits for controlled precursors
    • Research-use-only labeling for non-GMP investigational work

    Typical usage ratio

    • 0.1–10 g per synthetic reaction, tailored by target compound, molecular scale, and project phase

    Downstream process integration

    • Dilution in specific solvents and pre-reaction activation, per detailed experimental protocols
    • Dosing into multi-step or convergent synthetic routes
    • Reaction monitoring by TLC, HPLC, or NMR at key intermediate steps
    • Purification via silica gel chromatography, crystallization, or preparative HPLC

    Final product types

    • Small-molecule research compounds and intermediates
    • Bioactive candidate libraries for pharmaceutical discovery
    • Isotope-labeled or reference grade materials for analytical assay calibrators

    5. Raw Material for Agrochemical Research Compounds

    Within the crop-protection R&D sector, hydroxyurea acts as a building block to synthesize experimental active ingredients or formulation agents in seed and plant health investigations. Batch purity and traceability must meet laboratory registration requirements, particularly for compounds evaluated in field trials under regulatory observation. Reaction input amounts and mixing practices shift between early-phase synthesis and scaled pilot batches, always factoring in environmental and operator safety considerations.

    Industry compliance standards

    • OECD Good Laboratory Practice (GLP) compliance (crop protection R&D)
    • EPA and EU Regulation (EC) No 1107/2009 for lab input traceability
    • ISO 17034:2016 for reference material producers
    • Field-trial documentation and material tracking for regulatory submission

    Typical usage ratio

    • 1–25 g per reaction, scaled to trial compound design, with larger pilot reactions up to 100 g as allowed by lab permit

    Downstream process integration

    • Metered dissolution or slurry addition in round-bottom reactors for specialty synthesis
    • Reaction sequence design for selective derivative formation
    • Workup and extraction for compound isolation and bulk upscaling
    • Material characterization and assay verification prior to field application

    Final product types

    • Experimental active ingredients for herbicide or fungicide testing
    • Plant growth regulator precursors evaluated under regulatory field protocols
    • Synthetic reference standards for agrochemical analytical methods
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    Certification & Compliance
    More Introduction

    Hydroxyurea: Proven Quality from Direct Chemical Manufacturing

    Reliable Production and Trusted Performance

    Working with Hydroxyurea every day in our plant brings a certain respect for its chemistry and for the role it holds across the industrial, pharmaceutical, and research sectors. This compound’s reputation comes from years of hands-on production, stringent testing, and close work with end users looking to solve real-world challenges, not just laboratory curiosities.

    We supply Hydroxyurea with the simple formula CH4N2O2. Our batches generally register purity levels of 99% or higher—measured by our on-site quality control teams using recommended HPLC and melting point standards. This means fewer contaminants for the synthetic chemist, exact dosages for pharmaceutical producers, and fewer surprises for anyone using Hydroxyurea to test a biological pathway. We run equipment designed for high output and fine control, taking each batch through full traceability from raw feedstock to packed drum or export-grade bag before it leaves our facility.

    Why Labs and Manufacturers Rely on Us

    Hydroxyurea grows out of a straightforward synthesis—cyanamides and hydroxylamine sulfate form the backbone within our reactors. Yet, it is the post-reaction control that distinguishes batches. Laboratory users and pharmaceutical formulation teams have given us direct feedback: too much residual sulfate or heavy metals turns a simple workflow into a costly troubleshooting exercise. Our purification steps rely on physical separation, watched over by process chemists, with each lot checked against pharmacopeial guidelines where relevant.

    On the residence time, heating profile, and crystallization rate, even small tweaks can make a surprising difference in yield, flowability, and ultimate purity. We see these differences every week in kilo-scale pilot runs and full production. Our experience tells us careful control translates into better downstream handling—no clumping, smoother dissolution, and fewer process interruptions for fillers, tablet presses, and reactors alike.

    Applications: Where Experience Makes a Difference

    Most of our delivered Hydroxyurea supplies end up in pharmaceuticals—solid formulation facilities, compounding pharmacies, and contract research labs. Its value there is well established in sickle cell anemia management, oncology, and select antiviral projects. Because we work directly with producers preparing oral-dose forms, we understand the need for granular size control and the absence of residual solvents or moisture, all of which can limit processability. Our team often works directly with formulation scientists on batch-specific certificates and answers for compendial questions before orders even ship.

    Research institutions order smaller lots for cell culture studies, biochemical screening, or veterinary research. For these groups, we pay extra attention to shipping timelines, preventing physical degradation and keeping exposure to heat and humidity as brief as possible. Some chemical manufacturers buy in bulk for further synthesis in specialty polymers or advanced organics—often needing more technical confirmation around reactivity, side-product management, and batch repeatability. For these needs, our technical services team can provide access to our latest process notes, isolating information critical for downstream synthetic control.

    The Practical Differences Between Hydroxyurea and Other Products

    Hydroxyurea stands apart from analogs thanks to its specific mode of action and practical workability. Compared to urea or other nitrogenous materials, Hydroxyurea brings much higher water solubility, acting as both a versatile reactant and a potent biological modulator. In oncology and hematology, practitioners look for consistency in dose strength; shifting even a few percent off-spec throws off treatment protocols. From manufacturing side, we keep an eye on how this compound absorbs moisture and breaks down over time. The way we dry and seal product directly impacts shelf stability—a lesson learned from early years when product caked up during overseas shipments.

    There are times when researchers ask us about alternative reagents—thiourea, guanidines, or simple carbamates. Each has its place; none match the balance Hydroxyurea offers of reactivity with manageability. Thiourea shares some chemistry but carries more handling risks, including increased skin and respiratory sensitization, drawing stricter controls at the industrial scale. Hydroxyurea instead provides effective performance in downstream reactions and biological assays, with a safety margin that keeps hazard assessments manageable at handling scale.

    Managing Quality, Keeping Consistency

    Our main challenge as manufacturers comes in keeping every lot up to spec across seasons and production scales. Environmental shifts—humidity spikes, feedstock variability, batch equipment stresses—put pressure on our quality management system. Over years, we moved quality controls closer to the point of production. Each finished lot faces ICP-MS for trace metals, titration for purity, and water-content checks. By integrating these steps, we catch errors sooner, limit waste, and keep our partner labs stocked with material they can trust for published research and regulated manufacturing.

    Feedback cycles matter. Pharmaceutical clients often send us chromatogram readings; if our findings ever diverge, we rerun analysis, re-check calibration, or tighten sampling protocols. This process keeps both sides honest and builds credibility that does not come from data sheets or checkboxes alone. Long-standing customers include feedback on flowability or packaging issues; we design incremental changes—new liner films, changed drum seals, upgraded inner bags—that answer these needs with practical improvements rather than marketing claims.

    Working with End Users: Real Questions, Real Solutions

    Open communication with users makes a difference. Researchers sometimes ask for specific particle size fractions, depending on their suspensions or reaction kinetics. Our crystallization equipment can dial in certain size distributions, but this involves tradeoffs in throughput and cost. If a researcher’s workflow would stall without it, we run extra sieving and tailor to order. For process scale customers with high-throughput requirements, we focus more on uninterrupted logistics and in-line packaging solutions, less on fractionation.

    Many pharmaceutical teams come back to storage and stability concerns, sometimes tied directly to environmental controls in their facilities. For them, we document best practices using real shelf-life studies under variable humidity and light. This reduces waste and ensures the active ingredient stays on-label until the last day. End users in hot, humid regions invariably report packaging breakdowns unless we use extra barriers, so we built that into export protocols to minimize transit losses.

    Sustainability in Raw Materials and Process Improvements

    Demand for greater transparency in sourcing and lower total environmental impact presses on all chemical makers, not just us. For our Hydroxyurea lines, we shifted supply contracts closer to regional partners whose cyanamide and ammonia feed stocks meet both consistent purity and traceability. We commit to minimizing wastewater loads; as a result, more of our plant water now recycles through closed-loop systems for cooling and rinsing.

    Energy input grabs increasing attention. Hydroxyurea’s synthesis is not the highest energy draw in our catalog, but the need for precise temperature and pH control means careful scheduling and use of heat exchangers. As utility costs rise, these improvements show up as steadier expenses—not as cost cutting at quality’s expense. Any mechanical improvement—longer lasting gaskets, upgraded automation, digital process controls—reflects direct lessons from years of persistent maintenance v. downtime analysis. Not every update needs a branding campaign; instead, we focus on what brings reliable output for customers.

    Global Shipping Realities: Keeping Material Safe and On-Spec

    Shipping Hydroxyurea is less dramatic than some high-hazard chemicals, but it brings its own set of practical issues. The compound is hygroscopic and somewhat sensitive to temperature swings; bulk shipments exposed to port heat or warehouse damp can quickly deteriorate, losing flowability and increasing degradation byproducts. Over time, we adopted double-sealed inner bags and UV-blocking drums for longer hauls. Customs officers sometimes sample bags along the route; we still get calls from customers about lost inner liners, so redundancy in packaging matters for full journey protection.

    We keep regular contact with shippers in key markets to track shipment disruptions caused by weather, strikes, or regulatory reviews. Every delay increases risk to product quality. Some countries—especially in tropical climates—report more frequent handling issues, leading us to add local partners for last-mile refrigerated storage in extreme cases. A poorly stored drum can mean weeks lost for a pharma or research client; reducing this risk leads to stronger business over the long term.

    Looking Forward: Product Improvement and User Partnerships

    Every batch of Hydroxyurea that leaves our plant carries weight beyond immediate business. Medical providers count on steady supply for ongoing treatment regimens. Repeated cancellations or quality slips do more than annoy—they interrupt patient care or halt research advances. We answer this by supporting batch reservations for stable clients. For major contract partners, we offer rolling inventory and advanced warning of any feedstock or equipment changes in our plant, not waiting for the last minute to communicate.

    We set up review meetings with key industry partners to anticipate changes in pharmacopeia or best practices for clinical use. By collaborating early on technical requirements, we head off disqualifying surprises during regulatory submissions. Formulators and scale-up specialists teach us where bottlenecks arise, and we adapt—sometimes this means revalidating processes or investing in new drying and sieving equipment for better particle homogeneity.

    A Culture Built on Access and Accountability

    Manufacturing Hydroxyurea at industrial scale tests not only technical ability but commitment to transparency. We invest time in sharing what goes right, and particularly, what went wrong and how we fixed it. Customers ask about legacy production issues years after the fact—full disclosure on process changes brings trust that the next batch will meet tight standards. Our technical team publishes stability and composition data, not just marketing snapshots, so customers see real timelines and know what to expect in their facilities.

    Every client, from the multinational manufacturer to the university postdoc, deserves answers rooted in reality—from lot-level data to advice grounded in years of hands-on troubleshooting. Whether the issue concerns trace impurity spikes, shipment delays, or adjustments to package moisture containment, we field these daily because we know our job does not finish when the invoice clears. It ends when the downstream process runs without a hitch and documented results match the planned outcomes, batch after batch.

    Hydroxyurea: Quality, Relationships, and Responsible Manufacturing

    What we have built into our Hydroxyurea production line reflects decades of lessons learned from direct manufacturing—attention to purity, reliable logistics, practical batch control, and careful listening to user feedback. Each improvement, from better filtration to more transparent data tracking, exists because a real user hit a snag and said so. We stand behind every bag, drum, or bottle that carries our name, knowing its impact long outlasts its journey from the plant floor.