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Cytidine-5'-Triphosphate Disodium Salt Dihydrate

    • Product Name Cytidine-5'-Triphosphate Disodium Salt Dihydrate
    • Alias CTP
    • Einecs 222-718-1
    • 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

    649365

    Product Name Cytidine-5'-Triphosphate Disodium Salt Dihydrate
    Synonyms CTP disodium salt dihydrate
    Chemical Formula C9H14N3O14P3Na2·2H2O
    Molecular Weight 533.18 g/mol
    Cas Number 36051-63-7
    Appearance White to off-white powder
    Solubility Water soluble
    Purity Typically >98%
    Storage Temperature -20°C
    Application Biochemical research, nucleotide synthesis
    Ph Range 7.0-8.5 (50 mM solution)
    Maximum Absorbance 271 nm (H2O)
    Stability Stable at recommended storage conditions
    Melting Point Decomposes before melting

    As an accredited Cytidine-5'-Triphosphate Disodium Salt Dihydrate factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.

    Packing & Storage
    Packing White, opaque plastic bottle with a screw cap, labeled “Cytidine-5'-Triphosphate Disodium Salt Dihydrate, 1 gram,” tamper-evident seal.
    Shipping Cytidine-5'-Triphosphate Disodium Salt Dihydrate is shipped in tightly sealed containers under dry, cool conditions to maintain stability. It is usually transported with ice packs or as a refrigerated shipment (2–8°C), and protected from light and moisture. Appropriate safety documentation and labeling are included per applicable chemical regulations.
    Storage Store Cytidine-5'-Triphosphate Disodium Salt Dihydrate at −20°C in a tightly sealed container, away from light and moisture. Keep the chemical in a dry, well-ventilated area, and avoid repeated freeze-thaw cycles. Protect from potential sources of contamination. Handle under proper laboratory conditions, using appropriate personal protective equipment. Always follow institutional and manufacturer guidelines for storage and handling.
    Application of Cytidine-5'-Triphosphate Disodium Salt Dihydrate

    Applications of Cytidine-5'-Triphosphate Disodium Salt Dihydrate in Industrial Manufacturing

    Cytidine-5'-Triphosphate Disodium Salt Dihydrate plays a critical role in various industrial bio-manufacturing processes. As a high-purity nucleotide component, it supports demanding applications from large-scale nucleotide synthesis for mRNA production to enzyme-catalyzed reactions in diagnostic reagent industries. Below, we detail core industrial scenarios with precise formulation, process integration, and regulatory guidance.

    1. mRNA Vaccine and Therapeutics Manufacturing

    Messenger RNA (mRNA) production for vaccines and therapeutics requires nucleotide triphosphates of precise quality and purity profiles. Cytidine-5'-Triphosphate (CTP) serves as an essential substrate during in vitro transcription (IVT), ensuring reliable elongation and correct codon incorporation. GMP manufacturers integrate this raw material into RNA capping and elongation steps, with batch records subject to regulatory audits. Dosage varies depending on mRNA sequence length and enzyme system, and quality control rigorously tests for nucleotide purity and pyrogenicity before downstream application in vaccine or pharmaceutical production.

    Industry compliance standards

    • cGMP for Active Pharmaceutical Ingredients (ICH Q7)
    • European Pharmacopoeia (Ph. Eur.) quality attributes for nucleotides
    • US FDA 21 CFR Parts 210/211 (Drug Manufacturing)
    • WHO guidelines for biological manufacturing

    Typical usage ratio

    • 2.5–10 mM final concentration in IVT reaction mixtures, adjusted based on target mRNA transcript length and polymerase kinetics

    Downstream process integration

    • Dissolved under aseptic conditions; filtered into IVT reaction feed tanks immediately before mRNA synthesis
    • Combined directly with other NTPs, template DNA, and RNA polymerase in single-use or stainless bioreactors
    • Standard process includes enzymatic capping post-IVT, requiring nucleotide-triphosphate excess for yield assurance

    Final product types

    • mRNA vaccines (e.g., for influenza, COVID-19, or Zika virus)
    • Therapeutic mRNAs (for oncology, rare genetic disorders)
    • Cell therapy products utilizing in vitro-transcribed mRNA

    2. Diagnostic Nucleotide Reagent Manufacturing

    Manufacturers of nucleic acid amplification tests (NAATs), polymerase chain reaction (PCR) kits, and isothermal amplification reagents formulate nucleotide triphosphates in bulk lots to precise analytical specifications. Cytidine-5'-Triphosphate achieves consistent peak purity and lot-to-lot reproducibility, allowing the production of high-sensitivity diagnostic reagents. Bulk formulation integrates real-time QC checks, minimizing batch rejections and supporting downstream lyophilization for kit assembly.

    Industry compliance standards

    • ISO 13485: Medical Device Quality Management for IVD reagents
    • CLSI MM01 Protocols for Nucleic Acid Amplification Reagents
    • ISO 18113 for IVD reagent labeling and requirements
    • IVDR (EU 2017/746) for diagnostic product components

    Typical usage ratio

    • 200–500 µM per nucleotide in working PCR and RT-PCR master mixes, adjusted for multiplex assay design and amplification efficiency

    Downstream process integration

    • Added with the other NTPs during bulk reagent blending under monitored humidity and temperature conditions
    • Undergoes sterile filtration prior to aliquoting into master mix bulk lots
    • Material stability validated after lyophilization for final kit configuration

    Final product types

    • qPCR and RT-PCR master mix reagents
    • Isothermal amplification test kits (LAMP, RPA, etc.)
    • Point-of-care molecular diagnostic cartridges

    3. Oligonucleotide Synthesis and Labeling

    During the chemical and enzymatic synthesis of oligonucleotides and labeled probes, high-purity triphosphates are essential for synthetic and enzymatic extension steps. Research and industrial probe manufacturers dose CTP according to required sequence and modification density, particularly for RNA oligonucleotides destined for molecular detection products. Strict process controls and analytical lot release protect against incorporation of impurities that could interfere with oligonucleotide function.

    Industry compliance standards

    • ISO 9001: Quality management for chemical manufacturing
    • Research Use Only (RUO) labeling for oligo and probe reagents
    • GLP (Good Laboratory Practice, OECD guidelines) for probe QC
    • REACH regulation for chemical handling and worker safety (EU)

    Typical usage ratio

    • Varies from 50–500 µM in reaction mixtures for enzymatic synthesis, depending on template and primer concentration

    Downstream process integration

    • Added to primer-extension and fill-in reactions for RNA labeling
    • Integrated before solid-phase purification and desalting steps
    • High-performance liquid chromatography (HPLC) used for final product release

    Final product types

    • Fluorescent RNA/DNA probes for hybridization assays
    • Labeled primers for real-time PCR detection
    • RNA oligonucleotides for gene expression research

    4. Cell Culture Supplementation in Bioprocessing

    Specific cell lines—including those employed in biopharmaceutical and vaccine bulk substance manufacturing—require nucleotide supplementation to maintain productivity and genetic stability. CTP is included in cell culture feeds to enhance nucleic acid synthesis, especially during high-density perfusion and fed-batch processes. Precise dosing supports cell viability, while quality systems track identity, sterility, and absence of cytotoxic residues.

    Industry compliance standards

    • USP Chapter <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
    • Current Good Manufacturing Practice (cGMP) for Biologics (21 CFR Parts 600–680)
    • EMA Guideline on Human Cell-Based Medicinal Products
    • ISO 22442 for raw material risk management

    Typical usage ratio

    • 0.01–0.1 mM in culture media, optimal level determined by cell line metabolic rate and production phase

    Downstream process integration

    • Dissolved in sterile water for injection; filter-sterilized and added to media reservoirs
    • Fed at controlled intervals or via perfusion supplementation during bioreactor operation
    • Real-time cell viability and productivity monitoring for process adjustment

    Final product types

    • Monoclonal antibodies and therapeutic proteins produced in mammalian cells
    • Recombinant viral vector stocks for gene therapy
    • Bulk vaccine antigens for further downstream formulation
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    Certification & Compliance
    More Introduction

    Cytidine-5'-Triphosphate Disodium Salt Dihydrate: A Foundation in Nucleotide Manufacturing

    Understanding Cytidine Triphosphate (CTP)

    Manufacturing Cytidine-5'-Triphosphate Disodium Salt Dihydrate (CTP, Na2) puts the focus on biochemical precision and process reliability. Every batch traces its origins to rigorous selection of raw cytidine, strict adherence to aqueous-phase phosphorylation, and precise neutralization steps. As a chemical manufacturer, we’ve seen how each step can shape the purity profile and how strict controls in crystallization lead to consistent performance. CTP, Na2, appears as a white or off-white crystalline powder, freely soluble in water, delivering a defined pH in solution. Most applications center on biotechnology, enzyme-catalyzed reactions, molecular biology, pharmaceuticals, and diagnostic kit development, where batch-to-batch sameness means less troubleshooting and better reproducibility.

    Batch Integrity and Process Insights

    Operators and lab staff spend much of the production time tracking reaction conditions—pH, temperature, stoichiometry, and agitation speed—the building blocks for minimizing byproduct formation. Every kilogram produced typically means several in-process HPLC checks, UV-Vis scans to monitor nucleotide integrity, and fine-tuned filtration to keep inorganic salts from co-precipitating. Our long-term in-house data shows that skipping or shortening these steps inevitably increases impurity burdens downstream, which complicates lyophilization and reconstitution for users in research or production workflows.

    Specification Matters: Quality Under the Hood

    In our experience, research and production teams care about more than purity on paper. High-purity CTP, Na2, with purity over 99% (HPLC), minimal pyrogen content, and specifications for heavy metals and residual solvents, simplifies compliance from bench research through to regulated manufacturing. Water content, usually ranging from 11% to 13% for the dihydrate, stems not just from storage environment but from subtle shifts in drying vacuum efficiency. Inconsistent hydrate levels impact not only analytical weighing, but also sensitive enzymatic reactions where the stoichiometry of phosphate groups and counterion ratios shift results.

    Why CTP, Na2 Fits Demanding Processes

    CTP, Na2’s main role appears in oligonucleotide synthesis, cell-free expression kits, and nucleotide-probing enzyme assays. Across customer audits and our collaboration with formulation specialists, we've encountered examples of buffer reactivity or counterion incompatibility—requiring an open channel for technical discussion. The sodium salt brings ease of dissolution and compatibility with a wide range of biocatalysts. Comparisons with CTP lithium or potassium salts show differing solubilities and downstream impacts on process conditions; sodium versions often support easier mass balances in aqueous phase processes, especially in enzymatic phosphorylation and cell-free systems.

    Monitored Stability and Extended Shelf Life

    Environmental controls, including humidity and temperature, affect not only shipping quality but also the shelf life at client sites. We design packaging based on our own accelerated stability trials and real-time storage studies. Glass bottles with desiccant, layered in mylar, and vacuum-sealed can stretch integrity to two years under cool storage. Our long-standing partnerships with pharma biomanufacturers stem partly from transparent stability data and rapid batch reanalysis after transit issues. Stability for CTP, Na2 extends to more than just label guarantee; it traces back to the consistency of upstream process control and continuous improvement.

    Common Challenges in Large-Scale Synthesis

    In scaling production capacity above single-kilo lots, the challenge isn’t just keeping up with demand but sticking to narrow windows for each process variable. Operators note a fine margin between over-phosphorylation, which leads to triphosphate analogs, and underreaction, which leaves unmodified nucleotide behind. Both affect end purity, measured by HPLC and mass spectrometry, and can introduce lot variability. Equipment clean-in-place validation and trace metal limits present bottlenecks for cGMP operations. Electrolytic sodium sources and ultra-pure water systems add even more layers of control—factors that dictate success in large-volume supply for vaccine raw materials or therapeutic development.

    Distinguishing From Other Nucleotides, Kits, and Reagents

    Research labs and industrial users often compare CTP sodium salt directly with ATP, UTP, and GTP counterparts. Each nucleotide carries its own quirks—CTP, Na2 offers distinct molecular weight, solubility, and stability, shaping specific reaction endpoints in DNA and RNA polymerization, tRNA charging assays, and metabolic labeling. We talk directly with users about where off-specification material could derail long-term studies or pilot-scale production runs. For diagnostic kit makers, our CTP dihydrate enables the design of robust amplification mixes. Differences from lyophilized or anhydrous forms are significant—rehydration time, exact assay concentrations, and container-lot consistency all hinge on sound manufacturing practice.

    Product Form: Why the Dihydrate?

    We produce the dihydrate specifically for its predictable hydrate content and ease of handling compared to anhydrous salts, which draw moisture rapidly and clump. Through ongoing stability monitoring, we’ve reduced lot-to-lot variation and eased the learning curve for technicians reconstituting stock solutions, particularly in high-throughput screening or clinical development labs. The dihydrate’s measured water content factors into the gravimetric calculations for precise substrate or reagent mixes. Unlike anhydrous forms that may distort mass-based dosing, the dihydrate delivers tighter control over nucleotide concentrations batch after batch.

    Down-to-Earth Production Challenges

    Any large-scale nucleotide plant operator will recognize the headaches from tubing blockages, particulate formation from salt precipitation, or variable pH drift during long reaction times. After years of process optimization and firsthand troubleshooting, we tune reactor protocols not simply for theoretical yield, but to minimize hands-on adjustments and unplanned downtime. Monitored glycol jacket temperatures, constant conductivity readings, staged addition of sodium hydroxide and cytidine, and multiple filtration loops yield powder with proven reproducibility. We share these insights through technical support because successful research hinges on reliable raw materials, not just numbers on a certificate.

    Beyond the Lab: CTP, Na2 in Scalable Pharma and Biotech Pipelines

    Progress in mRNA vaccine technology, gene therapy, and safer diagnostic kits depends on upstream nucleotide quality. Our regular engagement with biotech developers led us to refine anti-contamination protocols and batch records, anticipating client demands for traceable lots and rapid troubleshooting support. Regulatory audits regularly focus not only on our incoming raw material chain, but also on data archival, cross-contamination risks with other nucleotide lines, and ongoing risk assessment for allergen or endotoxin carryover. Getting all this right reflects on batch certificates and downstream development milestones.

    Supporting Analytical Confidence

    Research partners count on a consistent absorbance at 265 nm and exact phosphate analysis for precise dosing, eliminating the need for lab-by-lab recalibration. Quality monitoring isn’t delegated to a single checkpoint. It draws on years of cross-run data—absorbance variation, metal ion contamination, microbial bioburden trends, and crystallinity profiles. Our QC labs track trends in melting point, water uptake on desiccation, and the results of pyrogen and nucleic acid contamination tests. These cumulative records enable fast answers to client technical questions and form the backbone of our batch release system.

    Adapting to Customer Feedback: Real Process Improvement

    Researchers expect every characteristic of CTP, Na2 to translate predictably into their workflow. Feedback won’t get overlooked or lost in the shuffle. Pharmaceutical partners share details on precipitation or assay interference during scale-up; diagnostics producers report on reproducibility in PCR platforms. We invest in process modification based on these trends. When users detect trace heavy metal spikes from process water, we test source materials, review resin exchange protocols, and overhaul filtration. Documented improvements don’t just check boxes, they feed into our drive to deliver products that back up lab and clinical claims every time.

    Environmental and Safety Commitment

    Chemical manufacturing introduces unavoidable impacts on water, energy use, and waste. We invest in solvent recovery systems and water recycling protocols, both for regulatory compliance and company values. Process waste undergoes neutralization and staged filtration before disposal, tracked against documented thresholds. For every batch, staff carry out risk assessments and scenario planning—glovebox use, eyewash station maintenance, spills, traceability for hazardous byproducts—because end users depend on both the safety of the product and the conscientious stewardship from source to delivery.

    Ongoing Solutions for Industry Needs

    Every partnership in diagnostics, pharma, or industrial biotech brings new technical questions—buffer compatibility, sensitivity in complex matrices, shelf life in finished kits. We keep communication open, adapting production scale, packaging formats, and shipment cycles in response to evolving needs. Margins for error in CTP, Na2 synthesis may shrink as applications advance, and end-use requirements shift. Our workforce adapts training continuously, blending deep process knowledge with current analytical techniques. In practice, this commitment to learning and process feedback delivers direct benefits to those who rely on nucleotides to advance their own technologies.

    Supporting Your Innovation With Every Batch

    Manufacturing CTP, Na2, we stand behind more than just analytical numbers. Direct conversations with end users drive our bench-to-bulk approach, focusing on real challenges in synthesis, quality control, and downstream use. We have built and refined our processes to respond to the rigors of regulated production, the pressures of research innovation, and the practical realities of large-scale method transfer. Our commitment extends from the first reactor run through every technical call and field report, translating process integrity into results you can measure in the lab or on the production floor.

    Why Choose CTP, Na2 From a Direct Manufacturer

    Collaborating directly with a manufacturer brings genuine advantages in traceability, responsiveness, and technical integration. Our teams understand each nuance in process chemistry—because we set up, run, and validate every step. Problems aren’t abstract; they have concrete roots and targeted solutions. Every lot links back to process documentation, and user feedback feeds straight into operational improvements. When a new application arises or a supply chain disruption threatens timelines, we respond proactively, drawing on reserves of experience and material ready for dispatch. Partnership with the origin of production ensures accountability, reliability, and a technical foundation built on first-hand process knowledge.

    Final Thoughts From the Production Floor

    Behind every gram of Cytidine-5'-Triphosphate Disodium Salt Dihydrate stands a team accustomed to digging into the details and innovating through hands-on experience. Our history producing CTP, Na2 reflects an ongoing dialogue with the field, not just a formula on a label. From the equipment we choose and the raw materials we source, to process precision and technical troubleshooting, every decision aims to support advances in life sciences, diagnostics, and biomanufacturing. Progress often traces back to the smallest components—nucleotides with the right quality and consistency. Those who depend on CTP, Na2 deserve a supplier who knows every step, meets every demand, and grows through real-world partnership.