|
HS Code |
783676 |
| Generic Name | Docetaxel |
| Brand Name | DocetaxelDoc |
| Form | Concentrate for solution for infusion |
| Strength | 20 mg/ml |
| Route Of Administration | Intravenous |
| Therapeutic Class | Antineoplastic agent |
| Indications | Breast cancer, non-small cell lung cancer, prostate cancer, gastric cancer, head and neck cancer |
| Manufacturer | Doc Generici |
| Storage Conditions | Store below 25°C, protect from light |
| Packaging | Vial |
As an accredited DocetaxelDoc factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | The packaging for DocetaxelDoc contains 80 mg/2 mL solution in a clear glass vial, sealed, with tamper-evident cap. |
| Shipping | DocetaxelDoc should be shipped in accordance with cold chain requirements, maintaining a temperature of 2–8°C. The package must be clearly labeled as a cytotoxic agent and accompanied by safety data sheets. Shipment should comply with all regulatory guidelines for hazardous pharmaceuticals to ensure product integrity and handler safety. |
| Storage | DocetaxelDoc should be stored in its original, tightly closed container at a temperature between 2°C and 25°C (36°F and 77°F), protected from light and moisture. Do not freeze. Keep away from incompatible substances and out of reach of unauthorized personnel. Follow institutional guidelines for storing cytotoxic chemotherapeutic agents and ensure proper labeling and secure storage to prevent accidental exposure. |
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Purity 99%: DocetaxelDoc Purity 99% is used in breast cancer chemotherapy, where it ensures high antitumor efficacy and reproducibility in clinical outcomes. Stability Temperature 25°C: DocetaxelDoc Stability Temperature 25°C is used in hospital pharmacy compounding, where it maintains drug potency during storage and handling. Particle Size <10 µm: DocetaxelDoc Particle Size <10 µm is used in intravenous injection preparations, where it allows for optimal dispersion and minimal risk of embolism. Solubility in Water 0.04 mg/mL: DocetaxelDoc Solubility in Water 0.04 mg/mL is used in formulation of injectable concentrates, where it aids in precise and consistent dosing. Molecular Weight 807.88 g/mol: DocetaxelDoc Molecular Weight 807.88 g/mol is used in pharmacokinetics studies, where it enables accurate modeling of drug distribution and metabolism. Viscosity Grade Low: DocetaxelDoc Viscosity Grade Low is used in automated infusion systems, where it permits smooth and uninterrupted medication delivery. Melting Point 232°C: DocetaxelDoc Melting Point 232°C is used in sterile powder production, where it supports thermal stability during lyophilization processes. Residual Solvent <0.5%: DocetaxelDoc Residual Solvent <0.5% is used in oncology clinical trials, where it minimizes patient exposure to impurities and enhances overall safety profile. pH 5.5–6.5: DocetaxelDoc pH 5.5–6.5 is used in parenteral solution preparation, where it reduces risk of irritation and improves patient tolerance. Endotoxin Level <0.2 EU/mg: DocetaxelDoc Endotoxin Level <0.2 EU/mg is used in injectable formulations, where it helps prevent febrile reactions and meets regulatory requirements for biopharmaceuticals. |
Competitive DocetaxelDoc prices that fit your budget—flexible terms and customized quotes for every order.
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In today’s oncology landscape, Docetaxel holds a clear role in the treatment of certain cancers. Our experience as a chemical manufacturer has shown that every chemotherapeutic batch depends on much more than meeting a product standard. DocetaxelDoc, our proprietary offering, reflects years of chemical process control, strict facility discipline, and a steady feedback loop from real-world oncology professionals. We’ve built DocetaxelDoc not to simply supply a molecule, but to support physicians, pharmacists, and researchers with a reliably consistent, pharmacopeia-compliant ingredient, batch after batch.
A solid product line in pharmaceuticals relies on detailed technical experience, not just technical documents. Our DocetaxelDoc comes formulated to align with internationally recognized standards. The chemical structure—C43H53NO14—remains the bedrock. We source and refine Docetaxel using a process that maintains purity while controlling for known impurities and residual solvents at every critical step. We supply the API in crystalline powder, stabilized and packed under controlled nitrogen to preserve quality from our facility to the pharmacy. Particle size control affects solution preparation and downstream formulation. We rigorously track distribution profiles, aiming for a consistent D90 within a target micron range. Each batch undergoes repeated HPLC, FTIR, and NMR testing, ensuring stereochemistry and purity above 99%.
Moisture remains a silent threat, both to stability and usability, especially for sensitive oncology products like Docetaxel. Our moisture management starts with raw material handling and continues through final packing. Every release includes Karl Fischer titration analysis with water content guaranteed below 2%, preserving stability and shelf life. From in-process pH monitoring to peroxide value screens, we verify there’s no drift in quality as we scale from pilot to commercial runs.
Hospitals and compounding centers call for Docetaxel powder to prepare ready-to-use solutions or suspension formulations. As a manufacturer, we’ve witnessed that solubility, ease of dispersion, and controlled reactivity are not minor details—they matter in every chemotherapy clinic. Our teams keep close contact with formulation experts to refine powder flow and mixing qualities. This attention translates to less time wasted in the compounding hood and greater confidence for technicians administering infusions.
Our process accommodates bulk pharmaceutical ingredients used for generic formulations, or sterile raw products that feed directly into advanced injectable form fill. Stability studies, both accelerated and real-time, confirm that even in regions with harsh transportation or storage conditions, DocetaxelDoc delivers the intended potency until ready for administration. Every order ships with CoA and full traceability, letting pharmacists review full impurity profiles and spectroscopic data, not just bare summaries.
Several companies make Docetaxel. Our distinction comes from hard-earned manufacturing discipline. We control the full chain, from early synthesis steps through micronization and final packaging. Every operator on our line is trained on oncology-specific GMP, with extra redundancies for cytotoxic materials. Process validation isn’t a check-box; our labs look for real batch-by-batch comparability through chemical fingerprinting—matching impurity profiles and particle size ranges, not only endpoint assay values.
Trace metal residues—like palladium or tin, common by-products of industrial synthesis—get extra analytical attention. It’s easy to overlook these in routine batches, yet we’ve seen how even ppm levels compromise biocompatibility. By adapting high-sensitivity ICP-MS protocols, every run of DocetaxelDoc shows trace metals below the most conservative thresholds.
Customers return to us because they experience less batch variation. Proteins in the original Taxus plant used for semi-synthesis can differ by harvest, so our botanical supply chain is rooted in audited agricultural partners, and we monitor them throughout the full season to ensure uniform quality. Our chemists challenge each lot with stress testing—simulated sunlight exposure, heat, and mechanical vibration—to screen for any tendency toward hydrolysis or polymorph formation.
The oncology field has changed over the years, with more demand for combined therapy regimens or novel delivery systems. Researchers turn to DocetaxelDoc as a reliable base for nanocarrier suspensions and antibody-drug conjugate investigations. Our manufacturing supports flexible molecule access. By working directly with academic and pharma research teams, we offer small-scale customizations—tailored particle sizing, lyophilized samples, or high-dispersion blends—so partners can explore new delivery routes without waiting on lengthy supply chain adjustments.
We view compliance not as paperwork, but as embedded process control. DocetaxelDoc meets all requirements from pharmacopoeia monographs, and our QMS covers full lifecycle traceability. Data integrity audits ensure no batch history gaps. Regulatory authorities want more than data on paper—they come for on-site audits, real-time production walk-throughs, and random lot sampling. Our batch records are open for inspection, and auditors leave with full analytical data sets, not summaries. This transparency shapes how we continually update protocols.
End-customers depend on us for uninterrupted supply. To meet that trust, our production lines run with multiple redundant QC points and backup utility plans. In regions with unpredictable power, our facilities carry dual generation to prevent lot failures in the middle of critical synthesis. We invest in continual equipment calibration—not only for performance, but to make sure every reading, every documented value, stands up to third-party review.
Clinical guidelines for taxane use change as new data emerge. We stay connected with regulatory advisories on allowable impurity thresholds and excipient interactions, integrating real-time updates into our manufacturing SOPs. For customers facing regulatory reviews, our technical support can supply underlying analytical details and stability documentation, giving direct evidence if queries arise during approval or post-approval audit cycles.
Docetaxel synthesis poses special environmental challenges. We draw on decades of procedural improvement to minimize solvents and control waste. Our EHS team meets regularly with local regulators and international stewardship bodies to keep benchmarked on emissions. Solvent recovery reaches a high percentage in our process, and solid waste undergoes full classified disposal. Safety and environmental standards have evolved dramatically, and our team adapts—selecting lower-toxicity reagents wherever data supports safety without sacrificing chemical yield.
We actively participate in take-back and recycling programs for secondary packaging, reducing landfill contributions linked to pharmaceutical manufacturing. Our facilities operate closed-loop air filtration, reducing airborne cytotoxic risk both to our workers and the environment. Each year, we publish our sustainability metrics so industry reviewers and customers have independent, third-party verified figures, not just internal claims.
Customers have sent us stories of interrupted cancer treatments, caused when another supplier’s Docetaxel failed intermediate-release testing—sometimes due to hidden degradation or shipment issues. In high-stakes applications like oncology, reliability starts with direct manufacturing, not third-party distribution. We maintain buffer stocks and forecast based on both firm and flexible commitments, preventing sudden shortages that ripple through hospital supply chains. Our customer service and logistics planning factor in customs clearance risks and support advanced shipment tracing.
For long-term partners, we offer lot reservation and custom release schedules, reducing the need for emergency reordering or unplanned overstocking. Each contract comes with direct access to technical and quality support—real chemical manufacturing professionals, not a commercial helpdesk with standardized answers.
Therapeutic innovation remains constant in oncology, but consistent raw materials often limit downstream advances. By supplying DocetaxelDoc to forward-thinking formulation teams, we see new approaches—from extended-release microspheres to site-targeted delivery devices—enter clinic trials and sometimes make it to market. Collaboration at the material supplier level gives these innovators a head start, free from last-minute raw material headaches.
Pharmaceutical manufacturing always involves people—chemists, operators, quality leads, and logistics specialists. With our DocetaxelDoc line, every batch release represents the accumulation of skill, vigilance, and open communication across teams. Our operators walk the line daily, overseeing more than automation. Routine visual inspection and manual verifications supplement the electronic controls, catching out-of-spec signals before they become lost lots or, worse, clinical risks.
New hires study side-by-side with senior staff, learning not just the steps but the reasons for each check. This direct knowledge transfer strengthens our line against staff turnover and unexpected challenges. In audits and customer visits, we open up our process, welcoming feedback to drive improvements.
Beyond batch production, our technical group helps customers adapt DocetaxelDoc to emerging clinical needs. Whether it comes to hot-melt extrusion for oral tablets or incorporating new excipient blends, we keep an open door for technical partnership. This isn't just about selling a raw chemical—it's mutual progress for advancing cancer treatment.
As the global need for reliable oncology APIs continues to expand, we keep investing in process innovation and staff development. Our journey with DocetaxelDoc isn’t static—the product line adapts as our partners’ projects move from initial research through to scaled-up manufacturing and clinical rollout. Every improvement comes from concrete experience—field failures, supply chain problems, and unforgiving audits—which we fold back into regular operations.
With DocetaxelDoc, manufacturing quality grows from direct feedback, practiced skill, and a commitment to open, traceable practices. Whether supporting large-scale generic production or the next generation of targeted therapies, we shape every lot based on science in action and the steady, often unseen, effort of the people who make it possible.