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Foscarnet Sodium

    • Product Name Foscarnet Sodium
    • Alias Foscavir
    • Einecs 263-293-5
    • 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

    556397

    Name Foscarnet Sodium
    Chemical Formula Na3CO5P
    Molecular Weight 300.05 g/mol
    Cas Number 63585-09-1
    Appearance White crystalline powder
    Solubility Freely soluble in water
    Storage Temperature 2-8°C
    Pharmacological Class Antiviral agent
    Route Of Administration Intravenous
    Indications Treatment of CMV retinitis in AIDS patients
    Mechanism Of Action Inhibits viral DNA polymerase
    Synonyms Phosphonoformic acid trisodium salt
    Ph Of Solution 7.4 (20 mg/mL solution)
    Density Approximately 2.6 g/cm³
    Packaging Vial or injection solution

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

    Packing & Storage
    Packing Foscarnet Sodium is packaged in 250 mL sterile glass vials, each containing 6 grams, sealed with a rubber stopper and aluminum cap.
    Shipping Foscarnet Sodium is shipped in tightly sealed, moisture-resistant containers, typically as a sterile powder or solution. It should be transported under controlled room temperature, away from light and incompatible substances. All shipping complies with regulations for pharmaceuticals, ensuring product integrity and safety during transit. Handle with appropriate protective measures.
    Storage Foscarnet Sodium should be stored at controlled room temperature, typically between 20°C to 25°C (68°F to 77°F). Protect from light, moisture, and excessive heat. Keep the container tightly closed when not in use. Do not freeze. If diluted for infusion, use promptly or store according to the manufacturer’s guidelines, and discard any unused solution appropriately.
    Application of Foscarnet Sodium

    Applications of Foscarnet Sodium in Industrial Manufacturing

    As a manufacturer of high-purity Foscarnet Sodium, we support a range of industrial processes where this specialty raw material delivers key functional, regulatory, and product outcomes. Below, we provide a detailed overview of four principal downstream applications, with scenario-specific information on compliance, ratios, processes, and product endpoints.

    1. Active Pharmaceutical Ingredient for Antiviral Injectables

    Leading pharmaceutical manufacturers rely on Foscarnet Sodium for the formulation of intravenous antiviral medicines targeting cytomegalovirus (CMV) retinitis in immunocompromised patients, including those with acquired immunodeficiency syndrome (AIDS). The synthesis and fill-finish stages must maintain precise quality to achieve regulatory approval. Production batches adhere strictly to pharmacopoeial and GMP norms, with validated incoming API testing, dissolution, and sterile filtration. The result is a fully compliant pharmaceutical that addresses global patient needs.

    Industry compliance standards

    • United States Pharmacopeia (USP)
    • European Pharmacopoeia (Ph. Eur.)
    • China Pharmacopoeia (ChP)
    • Current Good Manufacturing Practice (cGMP)
    • International Conference on Harmonisation (ICH) Q7

    Typical usage ratio

    • Formulation concentration: 24 mg/mL (2.4% w/v) in sterile water for injection; final dilution ranges from 500 mg to 6 g per patient dose as directed by prescribing protocols

    Downstream process integration

    • API fed into aseptic compounding tanks after incoming API QC
    • Fully dissolved under controlled agitation and temperature
    • Solution passed through sterilizing-grade filtration
    • Aseptic filling into glass vials, terminal autoclave sterilization as required

    Final product types

    • Lyophilized injectable vials for hospital use
    • Ready-to-inject sterile solutions (single- and multi-use)
    • Bulk solutions for contract fill-finish

    2. Reference Standard in Pharmaceutical Quality Control

    Pharmaceutical control laboratories and production quality units utilize certified Foscarnet Sodium as a reference compound for performance testing of finished dosage forms and lot release. Accurate quantitative analysis by HPLC or other validated methods requires materials that match monograph specifications for purity, water content, and assay. As the direct source, we provide the documented batch traceability and impurity data enabling full regulatory submission for both US and international registrations.

    Industry compliance standards

    • U.S. Food and Drug Administration (FDA) 21 CFR Part 211
    • European Medicines Agency (EMA) guidelines on analytical method validation
    • ICH Q2(R1) Validation of Analytical Procedures
    • WHO Good Laboratory Practice (GLP)

    Typical usage ratio

    • Reference standard typically 0.1 – 1.0 mg per assay, weighed with analytical precision

    Downstream process integration

    • Direct dissolution in chromatography solvents or mobile phase
    • Calibration curves generated at each analytical run
    • Batch release and stability monitored by routine and forced degradation studies

    Final product types

    • Pharmaceutical reference standards for regulatory submission
    • Quality control laboratory kits
    • Standardized assay solutions for GMP manufacturing

    3. Antiviral API Intermediate for Contract Manufacturing Organizations (CMOs)

    Contract manufacturers producing finished antiviral medications require reliable access to pharmaceutical-grade Foscarnet Sodium as a key intermediate input. The material enters their GMP-controlled compounding, blending, and lyophilization lines, which must maintain segregation to avoid cross-contamination with other active substances. Compliance with detailed material safety, stability, and regulatory origin documentation is critical throughout the production chain, ensuring the batch meets contract partner requirements and local authority approvals in destination markets.

    Industry compliance standards

    • ICH Q7 GMP for APIs
    • Qualified Person (QP) oversight under European Directive 2001/83/EC
    • China NMPA Drug Product GMP
    • ISO 9001:2015 certified quality systems

    Typical usage ratio

    • Blending input: 99.0 – 100.0% API purity; precise amount based on downstream formulation needs, typically matched 1:1 with target fill potency

    Downstream process integration

    • API transferred into segregated compounding suites with controlled access
    • Dissolution in batch tanks under validated process conditions
    • Downstream filling, lyophilization, and secondary packaging per client and regulatory protocols

    Final product types

    • Antiviral bulk injectable lots for downstream release
    • Branded and generic foscarnet medications for hospital distribution
    • WHO prequalified antiviral drugs for global tenders

    4. Pharmaceutical Process Development and Formulation R&D

    Specialty R&D centers and pharmaceutical innovators utilize high-purity lots of Foscarnet Sodium during preclinical and clinical process development. Formulation scientists conduct excipient compatibility, stability, forced degradation, and solubility studies to optimize processing conditions for registration batches. Direct input of fully characterized material supports robust data for Investigational New Drug (IND) and New Drug Application (NDA) submissions in major regulatory territories, including systematic documentation of analytical and process performance.

    Industry compliance standards

    • ICH Q8 Pharmaceutical Development
    • Good Laboratory Practice (GLP) – OECD and FDA
    • ICH Q1A(R2) Stability Testing of New Drug Substances and Products
    • EMA Guideline on Pharmaceutical Development of Medicines for Paediatric Use

    Typical usage ratio

    • Development scale: 0.5 – 50 g per study batch, adjusted based on lot size and testing scope; full-scale trial batches require up to several kilograms for preclinical and clinical phases

    Downstream process integration

    • Direct addition to laboratory-scale compounding tanks for solution or suspension studies
    • Integration into pilot-scale fill-finish runs
    • Comprehensive analytical evaluation during forced degradation and stability profiling

    Final product types

    • Process validation batches for regulatory submission
    • Stability study samples across different packaging systems
    • Phase I and II clinical trial materials
    • Analytical characterization panels for IND/NDA dossiers
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    Certification & Compliance
    More Introduction

    Foscarnet Sodium: Deep Dive from the Manufacturer’s Bench

    Authentic Experience with Foscarnet Sodium: Our Perspective

    In the world of antiviral pharmaceuticals, Foscarnet Sodium grabs attention for practical reasons. Every kilogram leaves our facility with a clear history of why and how it was made. We don’t chase trends or lightly change our process because antivirals have a direct impact on patient safety and therapy outcomes. Attention to consistent quality runs through every process stage. Despite many products offered in the market making similar claims, not all suppliers face up to the real hands-on intricacies of chemical synthesis, crystallization, batch analysis, and stability monitoring. Our team has spent years optimizing yields, impurity profiles, and storage requirements based on actual manufacturing experience and regulatory audit outcomes rather than speculation or resale commentary.

    Foscarnet Sodium looks simple on a molecular scale, but controlling trace metal content and polymorphic forms is no small feat. A manufacturer’s perspective never ends at yield; every step affects patients depending on that product. We have frequently encountered questions from clinicians and formulation scientists about particle size distribution and reactivity with container materials. Most focus rests on the active pharmaceutical ingredient (API) itself, but actual handling and downstream formulation present hurdles that rarely show up in superficial datasheets.

    Our Batch Production Approach

    Our Foscarnet Sodium typically leaves the reactor as a white or off-white crystalline powder. Each batch arrives at high purity through a careful process—dialed-in synthetic techniques, filtration stages designed for this compound, and critical washing procedures. Though our process follows accepted pharmacopeia guidelines, we test for more than just minimum compliance. Take the heavy metal content. Many end-users expect levels below 10 ppm; our teams routinely achieve even lower levels, driven by our facility’s in-house capacity for trace impurity testing. Any process deviation is flagged by rigorous quality control protocols built up through years of direct production experience, not adopted from industry hearsay.

    End-user feedback shaped the way our plant operates. Early feedback about batch-to-batch variability in moisture—a factor both for processing and shelf life—pushed our handling and packaging toward vacuum-sealed containers and moisture-barrier liners. Consistent water content is not about hitting a spec; it’s about confidence in use.

    Grade, Model, and Packaging as They Really Work

    Our common Foscarnet Sodium model targets pharma-grade API standards, with purity levels above 99%, residual solvent levels within strict regulatory limits, and a sulfate content profile suitable for downstream parenteral formulation. We run specifications by actual application—lyophilized powder for injectable use demands more stringent microbial and endotoxin controls than bulk powder for tableting. The significance of packaging isn’t lost on anyone who’s watched a shipment degrade through poor sealing or temperature spikes; this feedback comes directly from bulk buyers and handlers in multiple climates.

    Deliveries go out in double-sealed, light-blocking packaging with dedicated tamper-evidence, because every link in the distribution chain puts pressure on the material’s clean history. Our packaging decisions were set after too many reports of knock-off or repackaged material from secondary suppliers reaching the market. We bear responsibility for what carries our facility’s signature, so traceability systems follow every lot.

    What We See in Real-World Usage

    Foscarnet Sodium’s primary role in hospitals involves managing infections from resistant herpesviruses such as CMV and HSV. Infectious disease teams and pharmacists often ask about the compound’s solubility curves, as the clinical protocols depend on predictable reconstitution and dosing. Formulators report back on pH trends and stability of reconstituted solutions, especially under varying temperatures and light exposure. Our product’s solution profiles and compatibility checks take shape from those practical needs, not just regulatory minimums.

    Concerns come up about delivery devices and administration sets. As a manufacturer, we field queries about precipitation in central lines, compatibility with plasticizers in IV bags, and even the interaction between Foscarnet Sodium and tubing materials. These issues don’t show up in isolated lab reports, but in communication with end-users. Through feedback loops, we learn which formulation tweaks help troubleshoot real hesitation points for hospital pharmacists and clinicians. Our technical support routines build on these exchanges, not just spec sheets.

    How Our Foscarnet Sodium Differs from Outsourced or Resold Products

    There’s a big difference between working from raw manufacturing data and restating catalog information. Down the chain, resellers and traders sometimes only confirm broad specs without understanding how the product was made. We have seen poorly handled batches enter the market with moisture swings, inconsistent color, or undetected metallic residues. Our own product often lands on procurement benches directly against these unknowns; stepwise evidence trails, batch analytics, and recall procedures stand behind ours. We see this especially in contract manufacturing markets, where untraceable supply origins creep in when priorities focus on unit costs instead of end results.

    Some might claim all Foscarnet Sodium is the same, regardless of origin, but that ignores the reality of chemical process design’s impact. For example, controlling particle size distribution influences not only dissolution rates but also the risk of precipitation during IV infusion. We design our milling and sieving steps with end-use in mind, having responded to direct requests from researchers needing predictable dissolution times for critical-dose studies. That’s the difference makers who run the reactors and packaging lines every day can spot with a glance.

    Addressing Challenges in Production and Distribution

    The challenges don’t just exist inside our walls. Shipping a hygroscopic product like Foscarnet Sodium through varying climates presents its own set of real headaches. Over the years, we have handled everything from airport tarmac delays in humid cities to customs holds in dry, dusty regions. Packaging innovations came directly out of those struggles. We built redundant desiccant barriers and layered anti-tamper features after documented transit failures, not out of abstract best-practices checklists.

    Inventory management brings its own set of lessons. Hospitals and compounders prefer just-in-time delivery, but batch manufacture cycles don’t always dovetail cleanly with rush orders. It pushed us to build up both on-demand and made-to-order production schedules. Our plant’s buffer inventory system means a stockout at a distributor never has to ripple back as a patient issue. We don’t write the medical protocols, but delays in critical antiviral treatments because of out-of-stock ingredients shows up in the real world, not theory.

    Product Limitations and Paths Forward

    Foscarnet Sodium handles a niche set of infections within the larger antiviral spectrum. It remains restricted to those who cannot tolerate or do not respond to first-line antiviral therapies. While its mechanism—chelating viral DNA polymerases—remains a mainstay for certain patients, toxicity management (especially nephrotoxicity) limits broader use. This reality, which clinicians confirm, shapes the ways we communicate about the molecule’s strengths and boundaries.

    Ongoing improvements rarely come from top-down declarations; incremental adjustments come from side-by-side work with hospital pharmacies, clinical feedback after challenging administrations, or outcomes following adverse event reviews. This dialogue pushes for both process improvement and enhanced support materials, whether that means clearer reconstitution instructions for staff or additional validation on compatibility with novel infusion devices. When reported batch failures or reconstitution issues reach our support staff, root cause analysis feeds directly back into our production floor.

    Upstream Sourcing and Supply Chain Transparency

    Long before the final powder appears in a hospital’s compounding room, our focus goes upstream to starting materials. We maintain direct sourcing relationships for key raw chemicals, not only to keep costs predictable but to ensure prompt traceability in a recall. Only manufacturers see the true complexity of requalifying starting material suppliers; inconsistency in phosphate or formaldehyde inputs can jeopardize an entire year’s compliance record. We run parallel analytical checks on incoming batches, and it’s not unusual for our team to put a raw material lot on quarantine—even if documentation looks clean—pending additional confirmation testing.

    Global politics and logistics add another daily challenge. We have worked through supply interruptions during border closures and navigated customs controls as national regulatory frameworks shift. Our product release schedules have weathered longer lead times, stockpiling for strategic partners, and shifting transportation lanes. All of these factor into final customer experience and risk mitigation in ways traders rarely glimpse.

    Environmental Health and Regulatory Accountability

    Operating a chemical plant means meeting the health and safety expectations of both regulators and the communities around us. Wastewater containing phosphate streams, residuals from sodium-bearing processes, and plant emissions all add up. Every audit or regulator visit reinforces the need to go beyond minimum standards to protect operator health and downstream ecosystems. We invest in secondary containment and chemical treatment facilities based on historic site assessments and ongoing environmental reporting.

    The demands for documentation now run deeper than ever. Traceable manufacturing batch records, integrated with full environmental compliance files, allow us to support not just customer audits but also third-party, and sometimes regulatory unannounced screenings. Our plant’s participation in multi-year audit programs wasn’t prompted by a checklist, but by necessity. Many downstream pharmaceutical companies won’t touch untraceable sources of Foscarnet Sodium, and neither would we.

    Supporting Innovation: Collaborating Beyond Compliance

    We receive research access requests regularly—from universities, compound formulators, and clinical trial sponsors—asking for batch data, impurity profiles, and hydrolytic stability under new administration conditions. These projects rarely fit templated answers. Collaboration often drives us to take a closer look at our process deviations, especially when a published study or regulatory update shifts the landscape.

    During large-scale pandemic disruptions, delays in antiviral ingredient delivery spurred quick pivots in our scheduling and logistics. Our communications with innovators stress practical clarity: real-time, validated information on lead times, available lots, and documentation accessibility. Informed discussions carry more value than checking boxes.

    Looking at the Market: Facts Behind the Price Tag

    Real cost drivers for Foscarnet Sodium production center on equipment upkeep, solvent recovery systems, trained operator payroll, and ongoing validation expenses. The major input never appears on an invoice: invested time refining each part of the batch process to keep patient safety and regulatory metrics at the forefront. Market pressures often push pricing races to the bottom, but hidden supply disruptions or quality lapses emerge soon after. We remain committed to direct accountability for every production lot carrying our signature, resisting the temptation to cut corners for short-term gain.

    Buyers often ask us what separates a manufacturer-supplied batch from a procurement through an intermediary. Our honest answer: manufacturers live with the consequences in both short- and long-term recalls. We minimize risk through persistent, hands-on monitoring of every stage, from raw intake to finished shipment. That’s the accountability that, over time, earns our partners’ trust—and patient outcomes depend on it.

    Responsible Response: Handling Returns, Complaints, and Feedback Loops

    Not every batch sails out perfectly. Even with robust process control, we have handled returns on material that didn’t arrive as expected—clumping, container breaches, or perceived discoloration. We investigate every case, not just to placate the customer but to feed practical data into our batch history files. Each complaint prompts a process review, often resulting in tweaks to drying or packaging even if lab specs show compliant results. Honest communication between manufacturer and end-user shortens the path to resolution and process improvement.

    Recalls, while rare, become inevitable in the chemical manufacturing world. Our success takes root in maintaining recall readiness—with batch records, supply chain traceability, and dedicated recall plans that we have updated after each incident. This preparation, born of necessity and not marketing, forms a safety net for every supply relationship we keep.

    Beyond the Label: Supporting the Next Generation of Antiviral Delivery

    Foscarnet Sodium will continue holding an important place in certain antiviral protocols for complex and immunocompromised patients. We stay open to collaboration as hospitals, compounding centers, and innovators search for improved dosage forms, better compatibility parameters, or alternative drug delivery routes. Over the years we have participated in direct bench-to-bedside partnerships, sharing not just product but also process validation evidence, impurity data, and lessons learned.

    The journey from raw reagents to finished, ready-for-compounding Foscarnet Sodium powder is demanding, but we believe the process matters as much as the product. Partners who have worked with us know they can trace their material, ask for direct support, and receive up-to-date compliance documentation. Our years of chemical manufacturing inform every lot produced, every support answer given, and every improvement made in response to real-world feedback.