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HS Code |
345177 |
| Product Name | HIFULL HL-200 Hydrophilic Fumed Silica (Pharma Grade) |
| Appearance | White, fluffy powder |
| Purity | ≥99.8% |
| Specific Surface Area | 200 ± 25 m²/g |
| Ph Value | 3.7 - 4.5 (4% aqueous dispersion) |
| Loss On Drying | ≤1.5% (at 105°C for 2 hours) |
| Silanol Content | High |
| Average Particle Size | 5-40 nm (primary particle) |
| Bulk Density | 40-60 g/L |
| Heavy Metals | ≤10 ppm |
| Chloride Content | ≤0.03% |
| Ignition Loss | ≤2.0% (at 1000°C) |
| Cas Number | 112945-52-5 |
As an accredited HIFULL HL-200 Hydrophilic Fumed Silica (Pharma Grade) factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | The HIFULL HL-200 Hydrophilic Fumed Silica (Pharma Grade) is packaged in 10 kg double-layer kraft paper bags with inner PE liner. |
| Container Loading (20′ FCL) | Container Loading (20′ FCL): 68 drums × 100kg (net weight) per drum, totaling 6,800kg. Suitable for bulk pharmaceutical-grade shipments. |
| Shipping | HIFULL HL-200 Hydrophilic Fumed Silica (Pharma Grade) is securely packed in sealed, moisture-proof PE bags, typically within fiber drums or cartons, each containing 10kg or 20kg. Shipments comply with pharmaceutical transport standards, ensuring product integrity throughout transit. Store and transport in cool, dry conditions away from incompatible substances. |
| Storage | HIFULL HL-200 Hydrophilic Fumed Silica (Pharma Grade) should be stored in a cool, dry, well-ventilated area, away from moisture, heat, and sources of ignition. Keep containers tightly sealed to prevent contamination and absorption of moisture. Store away from incompatible substances. Ensure proper labeling and avoid generating airborne dust during handling. Follow all relevant safety and regulatory guidelines for pharmaceutical excipients. |
| Shelf Life | HIFULL HL-200 Hydrophilic Fumed Silica (Pharma Grade) has a shelf life of 24 months when stored in original, unopened containers. |
Applications of HIFULL HL-200 Hydrophilic Fumed Silica (Pharma Grade) in Industrial ManufacturingHIFULL HL-200 hydrophilic fumed silica, produced under stringent GMP and ISO systems, serves a critical role in multiple advanced industrial sectors requiring controlled rheology, high purity, and consistent performance. As an original manufacturer, we support pharmaceutical, food, personal care, silicone elastomer, and resin compounding industries with reliable supply and technical expertise to optimize end-product quality and regulatory alignment. 1. Pharmaceutical Excipients for Solid Dosage FormsLeading tablet and capsule producers use hydrophilic fumed silica as a glidant and anti-caking agent to improve powder flow, minimize aggregation, and achieve uniform particle distribution. The material is incorporated during the blending stage, allowing manufacturers to reduce manufacturing defects and ensure precise tablet weight and content dose, even at high-speed compression lines. The product’s high purity and consistency fulfill strict pharmacopeia requirements, supporting global export and regulatory registration. Industry compliance standards
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2. Food Additives in Powdered Ingredients and NutraceuticalsHigh-purity hydrophilic fumed silica is widely applied as an anti-caking agent and stabilizer in instant beverage powders, vitamins, functional foods, and sports nutrition blends. By reducing particle bridging and clumping, it ensures free-flow properties throughout production and in packaged consumer goods. The silica’s extremely low heavy metal content and traceability meet the requirements of large-scale ingredient producers supplying to regulated food and nutraceutical markets. Industry compliance standards
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3. Rheological Additive in Topical Pharmaceutical and Cosmetic GelsManufacturers of topical pharmaceutical gels and skin care formulations incorporate hydrophilic fumed silica to control viscosity, suspension stability, and thixotropic response. It supports rapid gelation, prevents ingredient sedimentation, and ensures spreadability. Its fine particle size and purity aid formulators in developing transparent hydrogel and clear serum products, compatible with actives such as corticosteroids, NSAIDs, and cosmeceutical agents. Industry compliance standards
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4. Reinforcing Filler in Silicone Rubber and Elastomer SystemsSilicone elastomer compounders use pharmaceutical-grade hydrophilic fumed silica for mechanical reinforcement, sag resistance, and improved tear strength in medical-grade hoses, stoppers, gaskets, and molded devices. Its controlled surface area and aggregate structure enable precise viscosity tuning, allowing robust extrusion and molding of high-consistency and liquid silicone rubbers for healthcare and critical applications. Industry compliance standards
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5. Thickening and Flow Control in Industrial Resin and Adhesive FormulationsProducers of industrial adhesives, sealants, and high-purity epoxy or polyurethane systems incorporate hydrophilic fumed silica to control flow, prevent settling, and tailor thixotropic properties for automated filling and precise bead application. Its compatibility with polar resin matrices and excellent dispersion properties underpin performance improvements in moisture-cure, UV-cure, and solventless technologies manufactured for electronics assembly, automotive, and appliance sectors. Industry compliance standards
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Competitive HIFULL HL-200 Hydrophilic Fumed Silica (Pharma Grade) prices that fit your budget—flexible terms and customized quotes for every order.
For samples, pricing, or more information, please contact us at +8615651039172 or mail to sales9@bouling-chem.com.
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Tel: +8615651039172
Email: sales9@bouling-chem.com
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At our plant, years of chemical engineering experience shape each product batch. HIFULL HL-200 Hydrophilic Fumed Silica (Pharma Grade) reflects what robust manufacturing and relentless process tuning can achieve. Over shifting shifts, we have learned that consistency and purity mark the difference between a lab curiosity and a staple ingredient in pharmaceutical formulations. HL-200 passes through rigorous decontamination processes, with operators tracking every variable in our controlled reactors. Our in-house experts don’t just create powder — they engineer critical performance.
With HL-200, we use flame hydrolysis of chlorosilane, which produces ultrafine, snow-white particles. Surface area hangs around the 200 m2/g mark — this has emerged as the sweet spot for both flow improvement and thixotropic effects in tablets and suspensions. Tools like nitrogen adsorption and automated particle sizers confirm the specifications batch by batch. This isn’t academic. Uncontrolled silica properties pop up quickly in tableting, affecting process flow and even final dissolution rates.
Every run, we build HL-200 for more than just technical purity. Trace metal content stays far below pharmacopoeial limits. Operators ensure each collection cycle delivers product with a silanol-rich surface for stable hydrogen bonding. Powder flow between packaging and use rarely throws surprises, giving pharma users a trusted ingredient whether they’re compounding oral suspensions or making microtablets. Feedback from customers with continuous manufacturing lines says HL-200 outperforms standard fumed silicas for flow and dispersion. These real-world details set HL-200 apart, not just data sheets.
Practical experience on production floors revealed HL-200’s versatility. R&D scientists reach for it to adjust viscosity in gels and creams, finding it holds up across broad temperature swings and pH shifts. Capsule and tablet production benefits from the powder’s superb glidant properties. In powders for reconstitution and direct compression tablets, HL-200’s fine structure keeps APIs dispersed, prevents caking, and speeds up mixing lines. Topical formulations stand out for their transparency and smooth skin feel, a nod to the ultrafine nature of our silica. Export clients working with sterile systems praise HL-200’s consistent microbial profile.
As a manufacturer, seeing the test data doesn’t fully explain the value difference. Commodity fumed silica often shows visible off-hues, inconsistent aggregator sizes, or trace impurities. HL-200’s pharma specialization includes much tighter heavy metal controls and a clean, reproducible surface chemistry. Repeat use reveals a difference: HL-200 disperses more easily and stays suspended, which shortens processing times or lowers downstream issues like filter clogging. In advanced excipient applications, especially ones regulated by global authorities, this repeat performance can shift a pilot project into a production mainstay.
Our largest partners run validation on every incoming batch. Over years, they report low batch-to-batch drift and report few complaints from auditors on silica traceability. Our technical support team often fields questions about scaling up trials from grams to tons — HL-200 matches well in every load thanks to a closed-loop feedback system. We regularly send our own quality experts to customer plants when they need process optimization or troubleshooting.
HL-200’s average particle diameter sits around 7 to 14 nanometers. This size grants a large surface-to-mass ratio, vital for absorbing and releasing liquids across a range of viscosities. Loss on drying, always a worry in water-sensitive APIs, rarely exceeds 1.5%, letting processors forgo unnecessary pre-drying. Tight control of bulk density (typical values 40-50 g/L) allows formulators to standardize mixing routines. HL-200’s amorphous, non-crystalline nature distinguishes itself from crystalline silica, which creates safety hurdles. These fine points only matter when real-world lines run continuously, keeping waste and rework under tight control.
In pharmaceuticals, purity dictates more than regulatory compliance. End users care about pyrogen content, heavy metals, and residual solvent levels because hidden contaminants can derail scale-up or fail quality audits. HL-200’s manufacturing integrates real-time FTIR and XRF inspection to keep off-specification product from reaching packaging. Trained lab analysts cross-check standard silica assays with more sensitive ICP-OES results to verify sub-ppm impurity levels. Even after years handling silica, our technicians track trace metal sources back to raw material lots and keep every sealable bag mapped with a lot history.
Direct conversations with plant engineers and formulators influence process changes every year. Customers point out minor caking or inconsistencies; engineers adjust hydration cycles or tweak feed rates to fix the issue in the next lot. Some large-scale tableting clients needed tailored silica with a slightly reduced surface area; we adjusted our reactor parameters and shut down for specialty production runs. None of these changes happen in a vacuum—they come from hands-on experience, on both ends of the supply chain.
Several multinational partners require HL-200 meets pharmacopoeial standards—USP/NF, Ph.Eur., JP, ChP. We cross-reference test protocols against regulatory updates. Documentation support comes not just as certificates but as traceable raw data, kept accessible through batch archiving. Inspections by external auditors have never flagged HL-200 for OOS issues because of this level of internal rigor. Export documentation allows smooth passage through customs in regulated markets.
HL-200 ships in multi-layer bags, tested for puncture resistance and humidity transmission. Storage and shipping facilities maintain stable conditions—temperatures between 15˚C and 25˚C and relative humidity below 50%. For customers worried about cross-contamination, each batch gets dedicated handling equipment and barcode-based tracking. Repeated transit stress tests show HL-200 resists both compaction and moisture up-take, avoiding clumping or scatter loss. This diligence stems from years of feedback and root-cause investigation of field issues.
Pharmaceutical clients often test HL-200 head-to-head against common brands. Direct feedback: HL-200 blends faster and shows less residue in mixing vessels. Some alternate grades contain higher levels of agglomerates, visible as grittiness in creams or delayed dissolution in suspensions. Our staff recall a generic manufacturer who switched to HL-200 after a competitor’s lot caused dose variability. After switching, their product maintained tighter weight and content uniformity. These stories don’t fit neatly into marketing brochures, but they shape why HL-200 holds a loyal niche in critical process lines.
Our technical team, not just a remote helpdesk, routinely visits major pharmaceutical clients. Field engineers provide root-cause analysis when customers face unexpected gel consistency, filtration slowdowns, or moisture pickup. More than a decade ago, we saw a surge in demand for antiperspirant gels, requiring custom-rebalanced silica for improved clarity—HL-200 became a lab favorite due to feedback loops between our R&D and user sites. Field troubleshooting created insights, showing how raw silica characteristics influence everything from capsule fill to bioavailability.
HL-200 didn’t emerge fully formed. It took dozens of pilot runs, feedback from line managers, and in-process audit data to achieve stable manufacturing. Early users highlighted issues like inconsistent bulk density or trace organics. Equipment upgrades, cleanroom extensions, and investment in triple-stage filtration built reliability into every batch. By collaborating with international and local formulators, we adapted processing parameters and documentation styles, making regulatory compliance less of a hassle for the next user.
Customer projects take HL-200 into diagnostic applications and drug delivery systems, where surface silanol groups matter. Our process leaves the surface fully hydrophilic without masking active sites. This distinct surface activity allows for strong hydrogen bonding in oral suspensions and gels. Customers working on suspendable antibiotics find HL-200 prevents sedimentation for extended shelf-life. These practical uses stem from engineering surface chemistry at the reactor, not just post-processing.
Fumed silica’s low density and high surface area demand careful handling. Operators use specialized scoopers, antistatic bags, and isolated feeds during packing. Customers report smoother integration when dispersion uses high-shear mixers, breaking up agglomerates. Our plant switched to negative pressure secondary containment after an incident highlighted airborne silicas' nuisance factor—lessons passed on to customers through best-practice briefings. Every operator receives training in safe transfer, minimizing dust exposure while maintaining product integrity.
Our facility recycles solvent-scrubbing media and recaptures off-gases from the hydrolysis process. Waste streams undergo repeated filtration, and spent bags are processed with local partners for responsible disposal. No batch leaves the plant without a full account of process water, emissions, and energy use low enough for international audit standards. Customers increasingly request “green” credentials as part of their own ESG targets; HL-200’s full-lifecycle reporting stands up to these demands.
Batch caking and blend separation sometimes arose, particularly in humid climates. Process tweaks at our end, such as drying room upgrades and real-time humidity monitoring, slashed customer complaints. Pack-down problems in high-speed tablet cams led to changes in HL-200’s flow agent calibration. We fielded requests from pharmaceutical blenders for more granular technical data, leading to the release of extended COA formats and QR-linked traceability records. Each process refinement comes from hands-on troubleshooting, usually in dialogue with technical teams on both sides.
Pharmaceutical warehouses storing HL-200 report no discernible shift in particle performance up to two years if kept dry and bagged. Routine retesting of reference samples matched well within original COA parameters, underscoring HL-200’s physical integrity. This stability spares downstream users the expense and uncertainty of product re-qualification every season, a common hassle with some lower-grade silicas.
Researchers crafting mucoadhesive gels and nanoparticle suspensions use HL-200 to tailor viscosity and optimize rheology. Direct input from leading R&D centers confirms our silica’s value in controlled-release coatings and transdermal delivery matrices. Unlike less refined grades, HL-200 does not contribute unwanted opacity or background signals in spectrophotometric assays. Innovations in oral thin-films and powder-in-bottle formats gain functional advantage by leveraging HL-200’s stable particle size and pure hydrophilic surface.
Whether a small compounder crafts a batch for clinical trial use or a multinational fills thousands of capsules an hour, HL-200 runs smoothly across line scales. Regional variations in process water or excipient grades seldom upset the interaction; surface chemistry engineered on our line means the silica matches performance expectations each time. Global customers see the benefit as HL-200 handles long export journeys, extensive climate shifts, and storage under variable conditions without degrading.
Our manufacturing team routinely hosts customer site visits and audit walkthroughs. Experts on both sides discuss silica behavior, troubleshooting live plant issues while sharing in-depth analytical results. Regulatory teams appreciate the open approach to documentation and rapid Q&A on historical batch trends. This ethos keeps trust high and invites new projects, as seen in repeat business from long-standing partners.
HL-200 Hydrophilic Fumed Silica (Pharma Grade) draws its reliability from decades of focused manufacturing and hands-on collaboration between our engineers, operators, and end users. Far from just another bulk chemical, HL-200 continues to underpin major pharmaceutical advances thanks to quality, dedication, and direct accountability from the source.
