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Sulfobromophthalein Sodium

    • Product Name Sulfobromophthalein Sodium
    • Alias bromsulphalein
    • Einecs 222-280-9
    • 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

    183670

    Cas Number 6268-67-5
    Molecular Formula C20H8Br4Na2O10S2
    Molecular Weight 751.1 g/mol
    Appearance Green to green-brown powder
    Solubility Soluble in water
    Melting Point Decomposes
    Storage Temperature 2-8°C
    Purity Typically ≥98%
    Synonyms Bromsulphalein sodium salt, BSP sodium salt
    Usage Used in liver function tests
    Ph Of 1 Percent Solution 5.5-7.5
    Light Sensitivity Light sensitive
    Stability Stable under recommended storage conditions

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

    Packing & Storage
    Packing Sulfobromophthalein Sodium, 25g, is supplied in a tightly sealed amber glass bottle with clear labeling and safety information provided.
    Shipping Sulfobromophthalein Sodium is shipped in tightly sealed containers, protected from moisture and light. It should be packed in accordance with chemical safety regulations, labeled clearly, and handled by trained personnel. During transit, it must be kept at controlled room temperature and safeguarded against physical damage to ensure product integrity.
    Storage Sulfobromophthalein Sodium should be stored in a tightly closed container, protected from light, moisture, and incompatible substances. Keep it at room temperature (15-30°C) in a dry, well-ventilated area away from strong oxidizers and acids. Ensure the storage location is clearly labeled and access is restricted to authorized personnel. Avoid exposure to extreme temperatures.
    Application of Sulfobromophthalein Sodium

    Applications of Sulfobromophthalein Sodium in Industrial Manufacturing

    As a primary producer of sulfobromophthalein sodium, we supply this specialized compound to industries with precise formulation, quality, and compliance requirements. Below are detailed applications in established downstream sectors, each accompanied by specific standards, quantitative references for incorporation, process positioning, and the resulting high-value end products supported by this unique raw material.

    1. Liver Function Diagnostic Agents in Clinical Laboratories

    Sulfobromophthalein sodium remains a critical diagnostic dye for evaluating hepatic excretory capacity in clinical chemistry laboratories. Applied as part of serum and plasma testing protocols, its precise pharmacokinetic profile enables differentiation of hepatic disorders by monitoring its uptake and excretion in human subjects. As an injectable reagent, its controlled formulation and compliance assure reproducible results in clinical diagnostic settings, where standardization and traceability are essential for patient safety and regulatory acceptance.

    Industry compliance standards

    • United States Pharmacopeia (USP) Monograph for Sulfobromophthalein Sodium
    • European Pharmacopoeia (Ph. Eur.) standard for diagnostic reagents
    • Good Manufacturing Practice (GMP) for Active Pharmaceutical Ingredients (APIs) and reagents
    • FDA 21 CFR Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals

    Typical usage ratio

    • Diagnostic formulation: 5–7 mg/kg body weight per test (adjustable based on age and clinical protocol)
    • Buffer solutions for ready-to-use injectables: 0.5–1.2% weight/volume, prepared under aseptic conditions

    Downstream process integration

    • Incorporation during the compounding step of injectable diagnostic dye preparations
    • Filtration and sterilization before aseptic vial filling
    • Quality control by batchwise HPLC and spectrophotometric purity checks

    Final product types

    • Sterile injectable diagnostic kits for clinical laboratories
    • Pre-mixed diagnostic reagent vials
    • Bulk solution concentrates for hospital pharmacies and diagnostic centers

    2. Pharmaceutical Quality Control and Analytical Standards Manufacturing

    Analytical laboratories and pharmaceutical companies utilize sulfobromophthalein sodium as a reference standard and quality control marker for testing analytical instruments and validating bioanalytical methods. Laboratories require traceable, high-purity materials to support calibration protocols, ensuring reliable detection and quantification during method validation, system suitability testing, and pharmacokinetic studies in drug development.

    Industry compliance standards

    • ISO/IEC 17025: General requirements for competence of testing and calibration laboratories
    • USP General Chapter <1058>: Analytical Instrument Qualification
    • ICH Q2(R2): Validation of Analytical Procedures
    • FDA Bioanalytical Method Validation Guidance for Industry

    Typical usage ratio

    • Standard solutions: 10–50 μg/mL for calibration curves and quality control runs
    • Spiking for recovery studies: 1–5% w/w of total sample matrix

    Downstream process integration

    • Preparation of primary reference materials in analytical labs
    • Serial dilution and formulation of working solution sets for calibration sequences
    • Pipetting and recovery studies during high-performance liquid chromatography (HPLC) validation

    Final product types

    • Certified analytical reference materials (ARMs)
    • Pre-mixed calibration solution kits for use in regulated laboratories
    • Bioanalytical control reagents used in drug discovery, toxicology, and clinical research

    3. Veterinary Hepatic Diagnostic Preparations

    Veterinary diagnostics manufacturers integrate sulfobromophthalein sodium into injectables and oral test formulations designed for assessing liver function in animals, primarily for use in research, breeding, and clinical practice with livestock, companion animals, and laboratory animals. Adaptation to animal metabolism and dosing demands highly consistent purity and formulation standards to support diagnostic accuracy and animal welfare requirements.

    Industry compliance standards

    • VICH GL9: Good Clinical Practice for Veterinary Applications
    • European Medicines Agency (EMA) guidelines for veterinary pharmaceutical preparations
    • National Research Council’s Guide for the Care and Use of Laboratory Animals
    • Pharmacopeia standards for veterinary products (e.g., Ph. Eur. 5.8, USP)

    Typical usage ratio

    • Dosage: 3–6 mg/kg body weight based on species, with veterinary discretion to adjust
    • Buffer suspensions for oral tests: 0.2–0.7% weight/volume in diagnostic vehicles

    Downstream process integration

    • Blending with sterile diluents during veterinary diagnostic formulation
    • Final sterilization and aseptic filling for animal hospital supply
    • Inclusion in packaged multi-use diagnostic kits for veterinary practice

    Final product types

    • Sterile veterinary liver function test injectables
    • Diagnostic oral solutions for large and small animals
    • Complete test kits for clinical and research veterinary laboratories

    4. Biochemical Research Reagents for Hepatic Transport Studies

    Academic and industrial R&D laboratories depend on sulfobromophthalein sodium as a model substrate in hepatic transport, bile excretion, and organic anion transport studies. The compound serves as a marker for evaluating cellular uptake, transporter inhibition, and excretion kinetics in both in vitro and in vivo systems, underpinning mechanistic research and early-stage pharmaceutical screening.

    Industry compliance standards

    • NIH Guidelines for Use of Chemical Reagents in Biomedical Research
    • OECD Principles of Good Laboratory Practice (GLP)
    • ISO 9001: Quality management systems in research reagent production
    • Institutional biosafety and ethical review protocols for experimental research

    Typical usage ratio

    • Cell culture assays: 2–20 μM final concentration per well, variable by cell model
    • In vivo rodent studies: 4–10 mg/kg administered intravenously or intraperitoneally

    Downstream process integration

    • Weighing and dissolving in physiological buffers for experimental dosing
    • Sterile filtration for cell-based transport assays
    • Preparation as a perfusion tracer in ex vivo liver perfusion systems

    Final product types

    • Bulk reagent vials for laboratory stocking
    • Single-use aliquots for microplate assays
    • Research-use-only packaged marker sets for transport and excretion studies
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    Certification & Compliance
    More Introduction

    Sulfobromophthalein Sodium: Reliability in Diagnostic Chemistry

    Understanding Sulfobromophthalein Sodium and Our Role as a Manufacturer

    Our experience over the years in synthesizing fine chemicals has shown us how critical each component in a diagnostic process can become. Among these, Sulfobromophthalein Sodium (Bromosulfophthalein Sodium, also known as BSP Sodium) stands out for practitioners who rely on its consistent behavior in liver function tests. We have invested in refining each stage of creating this compound, which is not only technical but requires care with each batch. The feedback from research labs and clinics we supply continues to shape our approach.

    Sulfobromophthalein Sodium, bearing the CAS number 14263-94-6, often comes in crystalline powder form. The signature purple or blue hue marks the quality of the lot. Our refinement process routinely centers on the sodium salt, as other salt forms do not offer the same water solubility or dissolution speed. We avoid shortcuts in filtration and crystallization. Moisture content and trace impurity levels matter significantly, as sulfur and bromine are both sensitive to manufacturing environment. Each kilogram we produce moves only after repeated controls for purity, often exceeding 99.0% as determined by strictly monitored HPLC analysis.

    Technical Specifications and Our Expectations for Manufacture

    We deliberately maintain narrow specification windows for Sulfobromophthalein Sodium to ensure batch reproducibility. Our most common model features a content level of 99.0% minimum, analyzed by UV absorption methods with cross-checks through HPLC. Water content rarely rises over 3.0%, achieved through low-humidity vacuum drying and stringent monitoring during packaging. Residue on ignition, a good benchmark for inorganic contamination, sits below 0.1%. Heavy metals, especially lead or mercury, are ruled out at levels below 10 parts per million.

    A reliable colorimetric indicator like Sulfobromophthalein Sodium relies on particle size uniformity, which speeds up dissolving in clinical assays. We avoid excessive milling, as this risks overheating delicate aromatic sulfonate groups, sometimes leading to tints or partial breakdown that end-users notice as unexpected baseline drift. Direct oversight during crystallization allows us to bypass irregularities that have affected the material in global supply shortages or from third-party brokers.

    Long-term customers know that packaging can affect chemical properties as much as synthesis routines. We have adapted by shifting to amber glass bottles in inert gas atmospheres whenever stock moves outside our region. This is a step beyond standard polyethylene bottles. Moisture and light create subtle shifts in the chromophore, changing the diagnostic results with only slight exposure over extended shipping or storage time.

    Performance in Clinical Usage

    Our first-hand connection with enzymology labs and pathologists highlights why Sulfobromophthalein Sodium sits at the center of many hepatic function studies. This compound delivers rapid and visible colorimetric shifts when binding to plasma proteins. Accurate clearance readings depend on clean sample backgrounds, as even minor trace contamination mimics hyperbilirubinemia results, introducing the risk of false readings. By controlling for trace organics, especially aromatic contaminants, we remove a variable from these pivotal diagnostic panels.

    We are acutely aware that every patient sample brings a different matrix, sometimes with challenging protein profiles or interfering medications. Our dedication to low-endotoxin levels protects downstream systems and avoids confounding results. Years ago, technicians noted that Sulfobromophthalein sourced from traders would increase interference background noise. With our vertically integrated plant, we can commit to annual improvements in pre-filtration and stove-drying operations, maintaining the shape and charge density of each molecule.

    Key Differences from Other Diagnostic Dyes

    Working with Sulfobromophthalein Sodium every day, we notice several distinctions from similar sulfonated dyes or phthalein derivatives. Many older diagnostic agents deliver broader, less defined absorbance peaks, which leaves clinicians needing larger sample volumes or repeated calibration. Sulfobromophthalein's peak absorbance, typically near 580 nm, gives sharp response curves, providing more reproducible measurements in both rapid screening and staged hepatic studies.

    Compared to dyes like phenolsulfonphthalein (PSP), which served as a previous mainstay in renal diagnostics, Sulfobromophthalein responds more quickly and fully clears in healthy livers. PSP often drags through the kidneys, skewing results if liver enzyme elevations co-exist with minor renal issues. Our customers have told us that choosing Sulfobromophthalein improves turnaround and reduces the rate of re-testing, especially with pediatric or geriatric samples where volume is precious.

    Other pigments—such as indocyanine green—have more complex preparation or require in-house solubilizer addition to prevent precipitation. In designing our Sulfobromophthalein Sodium lots, we work toward direct dissolution in standardized saline or buffer, keeping the technician’s workflow direct and decreasing error risk. Routine color converters or indicator paper rely instead on less specific dyes, which do not offer the selectivity our compound maintains for hepatic assessment.

    Our Process for Assuring Batch Consistency

    Quality in a specialty diagnostic agent is hard-earned, and we measure every step. Visual purity checks, repeat titrations, and particle size analysis run as standard practice. We maintain control from raw material verification through synthesis—beginning with bromination in high-purity solvents, monitored for temperature drift and reagent ratio. Each reactor cycle ends with a timed air-sparging step to drive off any volatiles before sulfonation, sidestepping the common risk of mixed by-products.

    We deploy LC-MS and elemental analysis on each batch, looking for possible homologues or side-chain traces. Our documentation and sample retention process builds a data trail through years of production runs. Customers sometimes request historic batch statistics, which we are able to provide down to chromatography traces. In a field where every microgram can shift downstream clinical readings, this matters a great deal for reproducibility in liver function screening.

    Recommendations from Experience

    Handling this dye calls for careful habit. Direct exposure to sunlight shifts color, as does high-room humidity, so we produce many lots during the dry season or in climate-controlled rooms. We urge end users to avoid storing working solutions in ambient light. Years of field visits revealed that low-resistivity distilled water ensures best initial clarity—regular tap water introduces ions that alter binding affinity. Even small changes to storage can prevent months of drift in baseline.

    Being open with end users, we note that faster shipment, tracking environmental exposure, and direct training on preparation often make a bigger difference than shifting assay protocols. Many in the clinical chemistry sector believe troubleshooting only belongs in the laboratory. Our teams have seen otherwise—minor shifts in pH or buffer make-up ripple from shipping conditions, handling, down to operator technique. Our support goes beyond supply and delves into training lab teams on the subtle ways to maximize consistency across test runs.

    The Real-World Value: Why Quality Sulfobromophthalein Sodium Still Matters

    Every decade, medical research shifts, and still Sulfobromophthalein Sodium holds its place as a reference compound in functional studies. Newer imaging methods or enzymatic kits surface, yet direct, colorimetric clearance remains a strong metric for liver dysfunction. Hospitals in regions with limited access to complex imaging find value in our material for affordable, rapid screening. Even sophisticated academic centers run comparative studies with our product against newer agents to establish baseline data.

    Adverse events related to contaminated Sulfobromophthalein made the news years ago, highlighting how excess bromide contamination can cause pronounced interference in hepatic toxicity studies. This prompted larger labs—and us as a manufacturer—to invest in tighter source control and lot tracking. Trace contamination causes more than false positives: it leads to misplaced clinical management and patient anxiety. This frame of reference shapes every decision, from raw supply selection to batch-wise impurity surveys.

    Continuous Improvement and Solutions to Old Challenges

    Innovation in chemical manufacturing does not always mean new chemistry. In our view, better monitoring and faster corrective intervention proved just as meaningful. We retooled vacuum dryers and replaced legacy glass reactors, introducing single-use polymer-coated steel where cross-contamination occurred. With regular blind retests against competitor’s samples, technicians spot outliers before material ever leaves our facility.

    Feedback channels stay open with our partners. Shared access to digital COAs, traceability for every bottle, and pre-release blind retesting set our bar for reliability. We work closely with diagnostic kit manufacturers to synchronize specifications and testing routines. If a customer suggests a packaging adjustment or modified drying technique that improves their results, we reevaluate our process and, whenever feasible, implement those insights plant-wide.

    Facing New Demands: Adaptation in Manufacture and Supply Chains

    Global shifts in raw material logistics have meant unpredictable lead times for core reagents. We observed early that bromine, a raw input, can fall into shortage, so we diversified our supply points before COVID-19 upended logistics worldwide. With direct ties to regional chemical refineries, we avoid the third-party resellers’ common purity problems, which too often pass unnoticed until test batches fail far from the original source.

    Transparent communication with our supply chain partners keeps us ahead of regulatory shifts, transport delays, or customs obstacles. During regional disruptions, we have responded by building buffer inventory and shortening batch approval review times. Clients working in time-critical settings—such as outbreak containment or seasonal check-ups—require firm reassurances on both timeline and composition, which our integrated workflow provides.

    Environmental Responsibility and Health Safeguards

    Operating at the scale we do, the environmental and health profile of each operation step matters. We have installed tertiary filters for effluents, eliminating brominated waste before discharge. With sodium-based dyes, we test final rinse streams for biologic compatibility, preventing ecological discharge above published thresholds. This step is about more than compliance. Employees handle the compound daily, so our monitoring extends to occupational exposure—glove use, local exhaust, site audits on every shift.

    Unlike trading houses, responsibility to local neighbors and regulators falls directly on us. We provide open-door tours where regulators or local university groups can review our on-site practices. Every cycle of process change involves a new risk assessment and staff retraining, not just box-checking. It builds a culture that values precision and care, reducing errors and nurturing a reputation for reliability hard to rebuild once lost.

    Looking Forward: The Place of Sulfobromophthalein Sodium in Evolving Diagnostics

    Manufacturing Sulfobromophthalein Sodium today means keeping pace with both regulatory tightening and rapidly shifting customer priorities. With stricter tolerances for allergenicity, bioburden, and residual solvents, specifications that once satisfied have become obsolete. Our technical heads collaborate across industry research groups, adapting not only to meet present demands but predicting how tomorrow’s requirements may impact trace impurity targets or bulk packaging needs.

    We have learned that standing still, even with a stable product, opens doors to irrelevance. By tracking regulatory discussions and emerging guidelines, we design in safeguards before official mandates. This future-readiness allows seamless rollout when regulations shift or assay formats adapt. As medicine explores deeper clinical markers, our Sulfobromophthalein Sodium stands ready to anchor both old and new protocols.

    Shared Experience and Commitment

    Decades in chemical manufacture teach caution, patience, and trust in good process. Our customers range from leading research hospitals running protocol trials down to regional clinics that rely on rapid, affordable diagnostics. They teach us the value of transparency. Every bottle of Sulfobromophthalein Sodium we ship represents an ongoing partnership—one where their data completeness, clinical accuracy, and assay reliability reflect directly on the upstream supplier.

    From raw input to final labeling, every aspect of our production ties back to these responsibilities. We listen closely—whether for subtle requests about granularity, unique buffer compositions, or new packaging styles needed for field testing. Our doors stay open, our data lines responsive, and our manufacturing teams attentive to the context in which Sulfobromophthalein Sodium will make a difference.

    This compound has earned its place in clinical diagnostics through decades of reliability. The trust our customers place in us, and the responsibility we feel toward each batch, continues to guide every improvement, every test run, and every package that leaves our facility.