Tengfei Creation Center,55 Jiangjun Avenue, Jiangning District,Nanjing admin@sinochem-nanjing.com 3389378665@qq.com
Follow us:

Ancitabine HCl

    • Product Name Ancitabine HCl
    • Alias Cyclocitabine
    • Einecs 253-800-2
    • 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

    953419

    name Ancitabine HCl
    synonyms Ancitabine hydrochloride, CI-921, NSC 136477
    CAS_number 35943-35-2
    molecular_formula C9H11ClN4O4
    molecular_weight 274.66 g/mol
    appearance White to off-white powder
    solubility Soluble in water
    mechanism_of_action Antineoplastic, purine nucleoside analogue
    route_of_administration Intravenous
    primary_use Treatment of certain cancers (anticancer agent)
    storage_conditions Store at 2°C to 8°C (refrigerated)
    stability Stable under recommended storage conditions

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

    Packing & Storage
    Packing Ancitabine HCl, 25g, is supplied in a sealed amber glass bottle with a tamper-evident cap and clear labeling for laboratory use.
    Shipping Ancitabine HCl is shipped in tightly sealed, clearly labeled containers to prevent contamination and degradation. It is transported as a hazardous chemical, adhering to all applicable regulations for handling, storage, and safety, with temperature controls as needed. Shipping documents include safety data sheets and hazard identification for secure and compliant delivery.
    Storage Ancitabine HCl should be stored in a tightly closed container at controlled room temperature, ideally between 20°C and 25°C (68°F and 77°F). Protect the compound from light, moisture, and incompatible substances such as strong oxidizing agents. Store in a well-ventilated, dry area designated for hazardous chemicals and ensure proper labeling to prevent accidental misuse or exposure.
    Application of Ancitabine HCl

    Applications of Ancitabine HCl in Industrial Manufacturing

    As a specialized manufacturer of high-purity Ancitabine HCl, we serve regulated pharmaceutical sectors requiring stringent quality, safety, and traceability. Our material supports downstream partners in preparing precise cytostatic and cytotoxic compounds across several targeted application scenarios. Each of the scenarios below reflects legitimate, industry-accepted use cases for Ancitabine HCl, underpinned by compliance with international standards and deep integration within customer-specific processes.

    1. Active Pharmaceutical Ingredient for Antineoplastic Drug Formulations

    Ancitabine HCl functions as a chemo-active nucleoside analog for the formulation of oral and injectable antimetabolite drugs targeting various hematologic malignancies. Pharmaceutical manufacturers rely on this API for its established synthetic pathways in finished dosage forms, while adhering to global regulatory frameworks for cytotoxic medicines. Production requires calibrated inclusion to achieve specific dose strengths within the narrow therapeutic index, demanding rigorous QC across compounding and final tableting or encapsulation.

    Industry compliance standards

    • International Council for Harmonisation (ICH) Q7 for API GMP
    • United States Pharmacopeia (USP) monographs for cytostatic APIs
    • European Pharmacopoeia 2.7.2 (Cytostatic substances)
    • U.S. FDA 21 CFR Part 211 (Finished Pharmaceuticals)

    Typical usage ratio

    • Ranges from 0.5–2.0% w/w in formulated cytostatic tablets or capsules, adjusted according to intended drug strength and mode of administration; precise concentration set by clinical dosage and approval dossier.

    Downstream process integration

    • Ancitabine HCl enters production during active ingredient blending, followed by granulation, compression, or filling; compounding carried out in dedicated cytotoxic suites equipped for containment and HEPA filtration.

    Final product types

    • Oral anti-leukemia tablets
    • Hard gel capsules for oncological indications
    • Concentrated bulk for further finishing

    2. Reference Standard Raw Material for Analytical Laboratories

    Accredited labs and pharmaceutical QC facilities require Ancitabine HCl as a certified reference material to calibrate and validate analytical methods, including HPLC/LC-MS quantitation for content uniformity and stability testing. Our manufacturing controls support strict documentation and traceability, enabling labs to monitor batch-to-batch consistency and validate recovery rates in research and development environments.

    Industry compliance standards

    • ISO/IEC 17025 (Testing and Calibration Laboratories)
    • Pharmacopoeial requirements for analytical standards (USP General Chapter <11>)
    • FDA cGMP for laboratories (21 CFR Part 211 Subpart I)
    • OECD Principles of Good Laboratory Practice (GLP)

    Typical usage ratio

    • 0.01–0.1 mg/mL solution for HPLC calibration; weighed portion size set according to method validation protocols and instrument sensitivity parameters.

    Downstream process integration

    • Enters workflow at method development and routine batch analysis stages; analysts prepare stock solutions and spiking samples for identity, assay, and impurity profiling.

    Final product types

    • Certified reference sample sets
    • QC control standards for pharmaceutical manufacturing
    • Analytical kit components for cytostatic drug testing

    3. Intermediate for Oncology Research Formulations

    Research institutions and R&D-focused pharmaceutical organizations use Ancitabine HCl for developing new anti-cancer agents and drug delivery models. Our production supports scale-up from lab synthesis through pilot batches, enabling controlled evaluation in preclinical and clinical study settings. Researchers use tailored concentrations when formulating solutions and suspensions for efficacy, pharmacokinetic, and toxicological assessment studies.

    Industry compliance standards

    • OECD GLP for preclinical safety studies
    • EMA Guideline on non-clinical pharmacology and toxicity studies
    • GMP for Investigational Medicinal Products (EU Directive 2003/94/EC)
    • 21 CFR Part 312 (IND Applications – U.S. FDA)

    Typical usage ratio

    • Typically used at 0.2–1.5% w/w for experimental oral or parenteral preclinical models, with adjustments per test species, target indication, and study phase.

    Downstream process integration

    • Incorporated during formulation trials, often with solubilizers or carriers; follows solution preparation and homogenization prior to in vitro or in vivo dosing in controlled facilities.

    Final product types

    • Experimental oncology study formulations
    • R&D scale pilot tablets or injection vials
    • Toxicological dose preparations

    4. Raw Material for Cytostatic Bulk Substance Export

    Bulk pharmaceutical manufacturers and contract development organizations purchase Ancitabine HCl in GMP-grade lots as a cytostatic raw material for export, destined for regional formulation under local registration. Bulk shipments require precise batch homogenization, serialized release documentation, and compliance with country-specific import requirements and transportation of hazardous substances.

    Industry compliance standards

    • WHO GMP for bulk pharmaceuticals
    • GDP (Good Distribution Practice) for cytotoxic APIs
    • Customs and Dangerous Goods Transport Regulations (ADR, IATA DGR)
    • Recipient country NMPA, CDSCO, or EMA import controls

    Typical usage ratio

    • Supplied as 100% pure, with downstream dilution or further processing at customer site; end-use ratio determined by customer-specific formulation dossier.

    Downstream process integration

    • Bulk raw input enters customer’s blending or API transformation stage, often followed by micronization or packaging in cleanroom conditions prior to final formulation.

    Final product types

    • Exported cytostatic pharmaceutical intermediates
    • Bulk API for regional finished dosage manufacturing
    • Controlled substance stocks for licensed formulators
    Free Quote

    Competitive Ancitabine HCl prices that fit your budget—flexible terms and customized quotes for every order.

    For samples, pricing, or more information, please call us at +8615371019725 or mail to admin@sinochem-nanjing.com.

    We will respond to you as soon as possible.

    Tel: +8615371019725

    Email: admin@sinochem-nanjing.com

    Get Free Quote of Sinochem Nanjing Corporation

    Flexible payment, competitive price, premium service - Inquire now!

    Certification & Compliance
    More Introduction

    Ancitabine HCl: A Practical Introduction from the Manufacturer’s Bench

    Our Experience with Ancitabine HCl Production

    Years of synthesizing nucleoside analogues in-house have given us firsthand insight into the consistent challenges and subtle victories of this field. Ancitabine hydrochloride stands out for its role in oncology research. Ask anyone who’s handled this material regularly—the straightforward manufacturing route fails to exist. Achieving reliable purity across batches demands technical skill with solid-phase synthesis, careful temperature regulation, and rigorous chromatography. Minor changes in process step timing or solvent grade significantly affect crystal habit and solubility, and any lapse shows up in an analytic fingerprint. Control matters on every level, so we automated sampling to catch deviations long before they reach the packaging line.

    Key Characteristics of Our Ancitabine HCl

    Our product emerges as a white to off-white crystalline powder, which reflects uncompromising attention to both process control and raw material sourcing. Experience tells us spectroscopic data alone never gives the whole story—the real test of Ancitabine HCl purity and stability happens in the lab after shipment, under real-world storage conditions. Water content, monitored closely by Karl Fischer titration, tends to drift if there’s even slight atmospheric moisture exposure during final drying. We deploy sealed containers with inert gas backfilling to limit this risk, keeping integrity until researchers open a fresh batch for their experiment.

    A robust product typically carries trace residual solvents far below official limits. We keep GC-MS certificates on file for every lot, confirming to our own satisfaction that users won’t face surprise peaks or unaccounted reactivity during their protocols. HPLC reveals the consistency in retention times and lets chemists troubleshoot with confidence before large-scale runs. UV spectral signatures help chemists track decomposition, so we monitor each batch from dispatch to field feedback.

    Intended Applications: Where Ancitabine HCl Makes a Difference

    The main appeal of Ancitabine HCl has always centered on its inclusion in cancer research—many workers target it for its antimetabolic activity and potential as a DNA synthesis inhibitor. Over the years, research teams reported phosphoramidate coupling with Ancitabine HCl working more efficiently than with related nucleosides. They cite smoother flows through standard purification steps and less clumping in their preparative columns. A few groups in antiviral development have also adopted it for early-stage screens, though oncology takes the lion's share of demand. We receive orders for preclinical methods as well, including projects on cell differentiation and cytotoxicity. Open communication with lab teams keeps our process grounded in working science, not just theoretical compliance.

    Stability beyond shelf-life specs makes a big difference for university and private labs, where a single bottle may see intermittent use over months. We still recall one customer running a series of delayed dose–response curves over nearly half a year from a single lot—retaining comparable results throughout. Their feedback pushed us to review and tighten our packaging moisture barriers even further. The end goal remains the same: enable reliable, repeatable science.

    Comparing Ancitabine HCl to Other Nucleoside Analogues

    Chemists regularly debate the merits of minor structural adjustments within nucleoside families. Ancitabine HCl brings some distinctive traits to the table, and long hours fine-tuning our own methods sharpened our appreciation for these differences. The compound demonstrates greater solubility in polar solvents than some other deoxycytidine analogues. Repeatable solubility means less waste and more predictable yields. It also shows cleaner degradation pathways under acidic or basic conditions, offering a clear edge in scenarios demanding precise impurities tracking—a point not always evident from product brochures.

    5-Aza-cytidine and similar drugs offer broader utility in certain methylation studies, but Ancitabine HCl provides cleaner chain termination under specific synthetic schemes. Researchers hoping to avoid side products have steered toward our material for this reason. From a process side, Ancitabine HCl’s crystalline habit simplifies drying and subsequent micronization, enabling better dispersion in both aqueous and organic media. Chemists working with fludarabine or cladribine often struggle with clumping or hygroscopicity, which slows downstream steps. Our batches of Ancitabine HCl typically pour free or flow smoothly from custom drums into dosing blenders, reflecting attention at every step of crystallization and drying.

    Cost inputs also reflect real manufacturing complexity. If you compare process data, Ancitabine HCl production calls for extra scrutiny in deprotection and extraction, and each handling step correlates directly with operator training burden. Where some analogues allow bulk synthesis with fewer steps, we tackle Ancitabine HCl batches with triple-checks on pH, batch size, and agitation cycles. These efforts directly support consistent output; the price reflects real-world time and labor, not just material costs.

    Practical Insights from Chemists on the Factory Floor

    Our technical staff often points out that small shifts in filter mesh selection or final drying temperatures become significant at scale. We documented cases where ironing out just a one-degree variation in oven set-point cut isolated impurities by almost a third. Experienced operators adjust vacuum levels during crystallization based on observed mass flow, drawing on years of accumulated process know-how. We capture and review logs from every run, so process improvements keep pushing our output quality higher.

    End-users sometimes report subtle differences between lots from different manufacturers—these typically trace back to upstream synthetic steps. Standardizing raw material QC and training operators to recognize borderline crystallinity before product reaches the QA lab helps us catch potential lots for rework, eliminating headaches at the client side. Whenever end-users suggest improvements, our team takes these seriously; frequent feedback from medicinal and process chemists shapes the way we refine our in-line controls.

    Shipping Ancitabine HCl long distances offers its own challenges. Temperature fluctuations during transit may trigger slow surface hydrolysis in poorly packaged material. Early on, some of our earliest shipments returned with altered assay results. We responded by rethinking the entire packaging and logistics process—choosing high-barrier, tamper-evident seals and qualifying a short route from production to loading dock, minimizing package dwell time. Out of dozens of subsequent shipments, follow-up assays matched dispatch results within a tight margin.

    Quality and Traceability from Batch to Bottle

    Maintaining traceability in this sector sets apart a true chemical manufacturer from bulk traders. Every Ancitabine HCl container from our plant can be linked back through digital batch records to the exact date and hour of its synthesis, the solvent lots used, and each QC checkpoint it passed. Operators get training not just on equipment function, but on the reasons behind these controls. We saw direct improvements in process outcomes after re-training sessions: fewer deviations, less waste, and easier troubleshooting.

    We place hard copies of analytics in the packaging itself. A researcher opening a box receives immediate access to their Ancitabine HCl batch’s HPLC chromatograms, NMR spectra, and water content data—no waiting on email requests, no ambiguity about what’s inside. Some customers require additional method validation; our team regularly supports those needs by reviewing methods together, ensuring test conditions and reference standards agree with our own in-house procedures. Every year, external audits push our controls further, and the resulting improvements filter straight into better product consistency.

    Reducing Downtime and Process Disruptions for Customers

    Customers rarely enjoy learning that schedule gaps or mismatches in analytical results trace back to variable material lots. By building redundancy into our weight checks, raw material inspections, and process step logs, we cut out unnecessary downtime, both on our end and for users waiting on critical shipments. In end-use environments like oncology labs, any replacement cost extends beyond price—it means lost research days, rescheduling of dependent assays, and real-world impact on project milestones. We take those downstream effects as our own, so improvements upstream never stop.

    Technical support after shipment really matters in specialty chemicals—problems or discrepancies don’t vanish at the dock. Our technical staff remains directly available for troubleshooting, including hands-on advice for process adjustments based on previous outcomes. We encourage open feedback, which gives us a continuous data stream for identifying small but critical systemic improvements. Each process tweak gets documented, with resulting trends reviewed systemically in internal planning. That feedback changes our SOPs and ultimately drives product quality forward.

    Addressing Industry-Wide Challenges in Ancitabine HCl Supply

    Inconsistencies plaguing nucleoside chemistry often boil down to upstream process controls and batchwise variability in reactants. Previous shortages during global supply chain emergencies brought hard lessons. We’ve had to pivot suppliers, validate alternates, and pay premiums for critical reagents, sometimes sourcing overnight. These disruptions place enormous pressure on small-scale researchers, who have less stockpile capacity than larger pharma customers. Having end-to-end process control lets us buffer against these disruptions better than traders or resellers ever could. Our storage tanks, blending lines, and in-line QC capacity give the flexibility to absorb short-term volatility.

    Unfair pricing swings also hurt true innovation, making it hard for small teams to plan multi-stage syntheses or pilot studies. By hedging key input contracts and building direct relationships upstream, we commit to providing stable pricing for core customers even when spot rates soar elsewhere. Bulk buyers get priority in lean seasons, but we always leave buffer inventory for academic labs and development-stage startups. This approach aims to support a full spectrum of scientific inquiry, not just well-financed projects.

    Building Trust with True Transparency

    Pharmaceutical and research organizations keep choosing our Ancitabine HCl because the material matches their needs, round after round. No one wants to waste funding rerunning controls; no one enjoys chasing obscure impurities traced to obscure third-party plants. Full transparency in our manufacturing records, analytics, and methodology distinguishes us from the many intermediaries in this marketplace. It’s never just about compliance for us; our satisfaction arrives each time a user reports flawless results across multiple batches.

    Material consistency means more than holding a spec—it means supporting synthesis outcomes with robust supply, batch after batch. Our operators, chemists, and QA specialists work in direct communication across departments. On-site management has technical backgrounds, so the language of purity, reactivity, and synthetic performance connects decision-making at every level. We share best practices openly with customers, take critiques without ego, and act on real feedback from those pushing scientific boundaries. Outdated habits give way to improvements, cycle after cycle.

    Ultimately, turning out high-purity Ancitabine HCl worthy of the world’s top research teams requires more than good intentions—it demands a working process, data integrity, real accountability, and informed adaptation. All those layers protect the reputations of the scientists and institutions who trust our products for their most meaningful work.