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HS Code |
642304 |
| Product Name | HIFULL HL-200 Colloidal Silica (Pharma Grade) |
| Appearance | Milky white liquid |
| Silica Content | 20% ± 1% |
| Ph Value | 9.0 - 10.5 |
| Particle Size | 8-16 nm (average) |
| Density | 1.15 g/cm³ (approximate) |
| Stabilizer | Sodium oxide (Na2O), ≤ 0.3% |
| Viscosity | ≤ 10 mPa·s (at 25°C) |
| Specific Surface Area | 200 m²/g (approximate) |
| Application | Pharmaceutical excipient, tablet disintegrant |
| Storage Temperature | 2-35°C |
| Cas Number | 7631-86-9 |
As an accredited HIFULL HL-200 Colloidal Silica (Pharma Grade) factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | HIFULL HL-200 Colloidal Silica (Pharma Grade) is packaged in 25 kg high-density polyethylene drums with secure, tamper-evident seals. |
| Container Loading (20′ FCL) | Container Loading (20′ FCL): 20 pallets, each with 18 x 30L drums, for a total of 360 drums per container. |
| Shipping | HIFULL HL-200 Colloidal Silica (Pharma Grade) is shipped in sealed, high-density polyethylene (HDPE) drums or intermediate bulk containers (IBCs) to ensure product stability and prevent contamination. Each container is clearly labeled and securely packaged to comply with pharmaceutical-grade handling requirements. Recommended storage is in a cool, dry place, away from direct sunlight. |
| Storage | HIFULL HL-200 Colloidal Silica (Pharma Grade) should be stored in tightly sealed containers, protected from direct sunlight and extreme temperatures. Store in a cool, dry, and well-ventilated area, away from incompatible substances. Avoid freezing and prevent contamination. Ensure containers remain upright and are clearly labeled. Follow all relevant safety and regulatory guidelines for chemical storage. |
| Shelf Life | HIFULL HL-200 Colloidal Silica (Pharma Grade) has a shelf life of 12 months when stored in tightly sealed containers. |
Applications of HIFULL HL-200 Colloidal Silica (Pharma Grade) in Industrial ManufacturingHIFULL HL-200 Colloidal Silica is engineered for high-demand pharmaceutical and life science applications, where strict regulatory compliance, traceability, and formulation reproducibility are essential. The following real-world downstream sectors demonstrate established uses of this specialized raw material, reflecting years of proven manufacturing practice and alignment with international quality benchmarks. 1. Tablet and Capsule Manufacturing (Pharma Excipients)Pharmaceutical manufacturers rely on colloidal silica as a flow aid, anti-caking agent, and glidant in tablet and capsule formulations, especially for moisture-sensitive or micronized active ingredients. Its high purity and controlled particle size distribution contribute directly to consistent blend uniformity, granule formation, and compression behavior, reducing content uniformity failures and supporting high-speed tableting lines. Colloidal silica’s inert properties avoid drug-excipient interactions, addressing regulatory expectations for excipient safety in oral solid dosage forms. Industry compliance standards
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2. Active Pharmaceutical Ingredient (API) Synthesis and PurificationChemical synthesis and crystallization processes for APIs often require colloidal silica as a filtration aid and clarifying agent. Its finely dispersed particles increase filter throughput, remove colloidal impurities, and stabilize supersaturated solutions during downstream purification. Manufacturers leverage its high surface area and neutral chemical profile, which avoid introducing interfering organics into high-purity drug substances, supporting impurity profile management for regulatory submissions. Industry compliance standards
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3. Parenteral Drug Formulation (Injectables and Infusions)In sterile injectable and infusion preparations, colloidal silica functions as a controlled suspension stabilizer and viscosity enhancer, supporting particulate-free product profiles required for regulatory clearance. It helps achieve uniform dispersion of poorly soluble APIs or lipophilic adjuvants in aqueous media, preventing sedimentation during filling and storage. Only colloidal silica meeting endotoxin, particle size, and bioburden limits is accepted for use in these applications. Industry compliance standards
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4. Medical Grade Coating and Controlled Release SystemsMedical device and drug delivery system manufacturers incorporate colloidal silica into polymeric coatings, implantable matrix formulations, and membrane films due to its capacity to modulate surface texture, controlled permeability, and drug release kinetics. Its pharmaceutical-grade traceability and consistent rheological properties meet strict risk assessment criteria for excipient use in medical combination products, especially where prolonged human contact or release regulation is regulated by international device directives. Industry compliance standards
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5. Hemodialysis Fluid and Medical Water PurificationColloidal silica is employed by manufacturers of medical-grade water and hemodialysis concentrates as a polishing agent for final mineral balance and turbidity reduction in highly purified, pharmaceutical waters. Its use ensures sub-visible particulate control in large volume parenterals and dialysis solutions, meeting patient safety requirements for chronic therapy formulations. Industry compliance standards
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6. Diagnostic Reagents and Laboratory ChemicalsManufacturers of in vitro diagnostic kits and clinical chemistry reagents use colloidal silica to manage reagent stability, control particle size in immunoassays, and assist in bioactive surface preparation. Its consistent physical properties and certified bioburden levels meet batch reproducibility needs for sensitive colorimetric, turbidimetric, or immunometric analytical protocols subject to regulatory oversight. Industry compliance standards
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Competitive HIFULL HL-200 Colloidal Silica (Pharma Grade) prices that fit your budget—flexible terms and customized quotes for every order.
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Tel: +8615651039172
Email: sales9@bouling-chem.com
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HIFULL HL-200 Colloidal Silica (Pharma Grade) stands as a result of years working directly in silica development, always focused on the practical realities of pharmaceutical production. Having seen countless changes in USP, EP, and JP guidelines over the years, our team never chases one-size-fits-all solutions. Instead, we listen to process engineers and production managers—those who face the actual issues every batch day. The pharma industry asks for more than basic purity or stability; it requires genuine peace of mind through raw materials that behave predictably no matter how tough the process gets.
Colloidal silica gives formulation chemists a fine tool for fine-tuning their tablets, capsules, and suspensions. HL-200 builds on decades of silica chemistry, leveraging lessons from both finished dosage trials and hands-on API blending. A good grade of colloidal silica not only has to meet official pharmacopoeia specs. Batch uniformity, flow, and how it interacts with laser particle counters often tell the story better than most test methods do. We've seen batches ruined by minor variances in surface area, or changes in zeta potential that create major downstream cleaning headaches. By sticking to a rigorous synthesis route and controlling aggregation at the nano level, HL-200 gives consistent behavior, even at high or low solids content.
From our lab benches to cleanroom production suites, every lot of HL-200 traces back to direct customer feedback. The requests we hear most: steady particle size, low bioburden, reliable ionic profile, and the ease of washing equipment afterward. You don’t get that list by browsing standards; pharma professionals who run granulation lines or suspension prep areas give this feedback through the daily grind. Any change—even a subtle one in chloride content or viscosity—doesn’t just show up on a datasheet, but in filter load, filter life, or even the color of the final product. We equip HL-200 with a narrow particle size distribution centered at the sweet spot where flow and dispersion work best for tableting and liquid suspensions.
HL-200 often stands apart not simply for how clean its chemistry is, but for what doesn’t happen in practice. Customers report fewer filter changes, less foaming during mixing, and lower rates of lot rejection relating to particulate contamination. The pH stays consistent across a wide storage window, so pharma plants often see easier downstream management without adjusting slurry parameters on the fly. Each feedback loop feeds our QC and R&D teams, keeping HL-200 at the same high bar batch after batch.
Pharmaceutical quality means far more than hitting a total impurity percentage. Over the years, we’ve seen how even minor blips in trace metal contamination can have dramatic effects downstream, particularly for injectable or ophthalmic drug forms. HL-200’s manufacturing route uses specially selected feedstocks and a controlled, clean system that keeps unwanted elements—arsenic, iron, and boron—far below typical benchmarks. In fact, many customers come to us after facing repeated stoppages caused by silica grades contaminated at the ore or precipitate stage. With HL-200, pure silica comes directly out of the process vessel each time, minimizing unknowns.
Silica’s interaction with actives and excipients goes well beyond flow aid or desiccant roles. For instance, in microemulsions and sustained-release platforms, even a trace of sodium or potassium changes crystallization or aggregation behavior. That’s why HL-200 holds a consistently narrow ionic profile that gives chemists fewer issues with batch reproducibility or unexpected gelation. Years of monitoring batch-to-batch salt drift informs our ongoing methodology. Customers rarely see those off-batch emails about ‘unexpected surface chemistry’ when they switch to this grade.
Not all colloidal silicas are created equal—even among products labeled for ‘pharmaceutical use.’ HL-200 steps above the common grades in ways that matter where it counts: process reliability, interaction with APIs and excipients, ease of cleaning, and regulatory comfort. A lot of commodity-grade silicas claim ‘high purity,’ but upstream supply choices and bulk processing mean small contaminants, variable solids content, and inconsistent viscosity. In contrast, HL-200 does not rely on recycled, low-grade silicon dioxide. It avoids shortcuts that can create variable charge environments across its colloidal particles.
Every liter matches strict ionic and microbial standards, not just for product registration but for practical plant performance. Technically, you might source a less expensive colloidal silica or opt for a food-grade version, but every lab manager who comes back to us does so after struggling with unpredictable foaming, sludging, or the cost of extra filtration. HL-200’s narrower particle distribution—measured and monitored using high-resolution DLS and validated wet chemistry—means fewer downstream headaches, less unpredictable haze in suspensions, and a tangible difference in finished product clarity, especially in injectable formats.
Manufacturing isn’t just about meeting paperwork standards for audits; it’s about running lines without shutdowns for filter blockages, variable flow, or unplanned cleaning cycles. HL-200 fits the practices of busy pharma plants by presenting as a stable, milky-white sol with a carefully balanced pH. That helps keep suspension prep lines running, where even a hint of flocculation or extra viscosity means stoppage and cleanup. Over the years, as new customers aim to scale up from research or pilot batch to full commercial, they value a silica that doesn’t make upstream agitation or downstream drying more complicated.
We’ve seen time and again: pharma teams adopt HL-200 because they can trust the solids content to remain within the stated window not just on the first drum, but case after case. This steadiness aids with in-line process analytical tech—fewer recalibrations, less out-of-spec alarms, and a more comfortable fit into modern QbD and continuous processing frameworks. Technicians tell us they save hours each month just from fewer filter clogs, less gelling on screens, and better compatibility across a variety of excipient blends.
PLANTS worldwide now face growing regulatory attention—not only for audit readiness but also for signals of quality lapses. Inspection teams drill down into every raw material certificate, looking for traceability and reproducibility. HL-200 meets this challenge by providing extensive, lot-specific certificates not just for the basics, but for elemental impurities, bioburden, and endotoxin content. Each lot’s microbial profile undergoes validation both at release and during long-term stability studies.
Customers rarely accept just a certificate. Today’s market demands third-party batch validation and access to analytical archives. HL-200 always pairs documented history with retention samples and ongoing comparative studies. Teams that run regulatory submissions lean on our in-house experts not just during validation, but as the product rolls into ongoing production. Old frustrations with ‘undocumented shifts in specs’ rarely crop up. That’s what lets global pharma operations sleep a little easier as they face tighter controls on data integrity and trace raw materials back years or even decades.
Beyond routine production, HL-200 gives formulation specialists and R&D groups a cleaner slate to build next-generation platforms. Whether the target is a novel extended-release oral solid or a delicate ophthalmic preparation, the predictable surface chemistry and lack of interfering ions leave fewer confounding variables for development teams. As more pharma companies explore continuous wet granulation and advanced CMC platforms, they need ingredients that don’t force extra design-of-experiment cycles due to latent batch-to-batch differences.
Our customers often report: tablets process differently, not just because of excipients’ names on a spec sheet, but because every micro-interaction counts. With HL-200, the aggregation profile means less variable moisture adsorption and more stable wetting—so processes lock in faster, and less time drains away in ‘troubleshooting’ unknowns. Teams developing nano- or microencapsulation benefit from HL-200's controlled particle size: fit for building reliable diffusion barriers or acting as an efficient carrier for poorly soluble APIs.
Reliability builds over years, not just one batch. Across our history working with both multinational and specialty generics plants, HL-200 has quietly become a steady presence—integrated not just as a purchased raw material, but as a partner in process design and audit preparation. Our technical team listens when plant managers report actual pain points: a sudden rise in jet milling screen blinding, shifts in pH drift during tank storage, or a spike in lab ion chromatography noise. HL-200 adapts to the real problems—not just hypothetical ones on paper.
Among the notes we hear most: “batch to batch, you know what you’re going to get.” Upstream QC walks the talk: every HL-200 lot ships only after passing elemental, microbial, and function-focused tests, not just generic purity reads. That gives customers a stable background on which to build SOPs, scale up new formats, or pass tough overseas certifications. Relying on HL-200, pharma producers free up their own teams—not to babysit solvents and filter changes, but to push ahead on drug design, regulatory submissions, and process innovation.
Silica’s role in pharma hasn’t plateaued. With combination therapies, advanced drug delivery systems, and biologics rising, ingredient reliability grows even more important. HL-200 leads by bringing not only compliance, but a clean, repeatable experience—important whether supporting early CMC studies or high-volume generics. The promise doesn’t come only from our synthesis route; it grows through partnerships with plants that expose our product to every odd pressure and heat/cool cycle real manufacturing throws at it.
Future pharma demands agility. HL-200 keeps pace by evolving batch controls and analytical support, keeping input levels of trace metals, microbial residues, and organics steadily trending downward. As regulations tighten and analytical scrutiny grows, HL-200 prepares customers to stay a step ahead—less unplanned plant downtime, fewer scrapped batches, and a smoother road through internal or FDA/EMA quality reviews.
HL-200 doesn’t claim to solve every pharma formulation challenge, nor does it rest on vague purity claims. Its design reflects decades spent debugging plant processes, confirming feedback through concrete tests, and refining raw materials that pharma teams rely on daily. In a field where even tiny material changes can ripple through to patient outcomes, nothing beats working with a supplier who values precision and stability as much as drug makers do.
Whether the focus is on producing millions of oral doses or a single, highly sensitive injectable line, HL-200 delivers the kind of no-excuse reliability required by modern pharmaceutical manufacturers. For those who want fewer surprises, shorter batch histories, and less time lost to troubleshooting, HL-200 Colloidal Silica (Pharma Grade) consistently proves it can shoulder the load.
