|
HS Code |
245503 |
| name | Phenacemide |
| synonyms | Phenylacetylurea |
| CAS_number | 63-98-9 |
| molecular_formula | C10H10N2O2 |
| molecular_weight | 190.2 g/mol |
| drug_class | Anticonvulsant |
| appearance | White crystalline powder |
| route_of_administration | Oral |
| mechanism_of_action | Sodium channel blocker |
| ATC_code | N03AG02 |
| melting_point | 157–158 °C |
| solubility_in_water | Slightly soluble |
| legal_status | Prescription only |
| indications | Treatment of epilepsy |
| brand_name | Phenurone |
As an accredited Phenacemide factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | Phenacemide, 100g, is supplied in a sealed amber glass bottle with a tamper-evident cap and clear hazard labeling. |
| Shipping | Phenacemide should be shipped in tightly sealed containers, clearly labeled, and protected from physical damage. It must be stored and transported in a cool, dry place, away from incompatible substances. Handling and shipment should comply with relevant regulations for hazardous chemicals to ensure environmental and personnel safety during transit. |
| Storage | Phenacemide should be stored in a tightly closed container, protected from light and moisture. Keep it at room temperature, generally between 20°C and 25°C (68°F and 77°F). Store in a cool, dry, well-ventilated area away from incompatible substances such as strong oxidizers. Ensure the storage area is secure and clearly labeled, restricting access to authorized personnel only. |
Applications of Phenacemide in Industrial ManufacturingAs a direct producer of Phenacemide, we supply this specialist active ingredient to leading industrial customers in regulated and high-purity sectors. Our plant supports niche mass production with accredited process control, batch documentation, and dedicated infrastructure for pharmaceutical and agrochemical downstream value chains. Below you will find major application scenarios for Phenacemide in global industry, including essential regulatory details, standard usage levels, workflow points of entry, and the resulting end products our technical clients manufacture. 1. Pharmaceutical Anticonvulsant FormulationManufacturers in the pharmaceutical sector use Phenacemide as an active pharmaceutical ingredient (API) to formulate prescription antiepileptic medications. Strict regulatory controls apply throughout the production chain, from raw material qualification and in-process QC to finished dosage validation. Downstream facilities blend Phenacemide with specific excipient systems according to regional pharmacopeia methods. Industry customers adjust their formulation strategies to meet tablet, capsule, or suspension dosage requirements, with titration and blending protocols under GMP environments. Finished pharmaceuticals are distributed as controlled prescription medicines for clinical seizure disorder management. Industry compliance standards
Typical usage ratio
Downstream process integration
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2. API Intermediate for Custom Synthesis HousesChemical synthesis and contract manufacturing organizations source Phenacemide as an intermediate chemical for targeted reaction sequences. These facilities handle chiral, condensation, and substitution reactions to produce complex drug substances. The received raw material undergoes identity testing before batch-wise integration into multi-stage reactor systems. Companies exporting custom APIs to regulated markets apply strict quality standards and change control. Final products undergo comprehensive purification and analysis steps before client shipment. Industry compliance standards
Typical usage ratio
Downstream process integration
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3. Reference Substance for Quality Control LaboratoriesAnalytical testing laboratories use Phenacemide as a high-purity certified reference material (CRM) to validate manufacturing lots and ensure identity, purity, and potency in regulated drug production. Laboratories calibrate chromatography and spectroscopy instruments with NIST-traceable standards. Routine uses include system suitability, method validation, and stability profiling under ICH guidelines. Robust documentation and audit trails accompany these applications to satisfy regulatory inspection and market release protocols. Industry compliance standards
Typical usage ratio
Downstream process integration
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4. Preclinical and Toxicological Study MaterialCROs and institutional research sites require Phenacemide as a validated test article for preclinical bioassays and toxicology studies. Researchers formulate animal dose preparations following standardized laboratory protocols. Facilities track compound provenance, stability, and animal use under GLP regimes. Dosing, observation, and data recording comply with global ethical guidance and reporting frameworks to support regulatory submissions and new drug applications. Industry compliance standards
Typical usage ratio
Downstream process integration
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Working in chemical synthesis for several decades shapes how we approach each product, and Phenacemide is no exception. As the manufacturer, we understand the science behind every batch. From our perspective, reliability starts with exacting standards during synthesis and purification. This way, our Phenacemide comes out consistent in purity and physical properties, without the batch-to-batch fluctuations that frustrate both development chemists and production managers.
Our facilities run with an eye toward both consistency and practicality. We produce Phenacemide mainly in crystalline powder with a controlled particle size, giving improved dissolution rates in laboratory and production environments. Analysts appreciate the low moisture and negligible residue on ignition. That doesn’t just happen by accident: it comes from years of watching, testing, and refining equipment and methods, all pushed by real experience making the compound at scale.
Chemistry and practicality go hand-in-hand once the product leaves the plant. Phenacemide’s main application has always been in the pharmaceutical space, specifically as an anticonvulsant. Development chemists and formulation scientists tell us that properties like consistent melting point and predictable solubility profiles can make or break a synthesis or pilot batch of a formulation. We notice time and again, batches that exhibit these uniform traits cut troubleshooting times in half, saving valuable time in preclinical and clinical development.
End-users, especially those working on new formulations or scaling up anticonvulsant therapies, want predictability—both in expected drug release and in regulatory documentation. With our involvement from raw material sourcing through the last drying and packaging step, we control the risk of out-of-spec residues or contaminants. Our clients rarely need repeat evaluations of our product’s properties once our certificate of analysis arrives with their shipment. That comes from a grounded understanding of both chemistry and the practical requirements of downstream users.
We manufacture Phenacemide primarily according to compendial standards set by leading regulatory bodies, with all batches tracked to tight process controls. Purity typically exceeds 99%, with minimal heavy metal content and defined water content, as confirmed by robust in-house quality checks. Unlike some generic producers, we do not see value in shortcuts with solvents, drying processes, or mill screening; if a batch fails in-house controls, it does not get shipped.
Each batch receives its own spectrum of analytical data: melting point, chromatographic purity, absence of related substances, and residual solvents. By avoiding third-party blending and warehousing, we deliver Phenacemide that matches its intended application. This minimizes headaches from regulatory authorities during submissions and commercial launches, which we know is a practical concern, not an abstract one.
Over the years, we receive regular questions about how our Phenacemide compares to alternatives, generics, and other classes of anticonvulsants. After extensive feedback and hands-on troubleshooting, some meaningful differences emerge.
First, our Phenacemide achieves a consistently high assay with minimal variation. Unlike some competitive lots coming through international brokers or with extended shipping times, our freshly produced batches travel directly from factory to user. This matters, especially where shelf-life stability and absence of degradation products become critical.
Second, we adhere to full traceability for every raw material lot and every processing step. While other suppliers may offer materials matching on paper, actual handling can introduce unknown impurities, affecting everything from bioavailability to regulatory acceptability. We have seen enough failed stability studies using lower-grade or decomposed material to know the stakes for both our reputation and the client’s entire project.
Third, we maintain strong on-site analytical resources. From NMR and chromatography to fine-tuned water content determination, our lab does not guess at data. This has practical value: researchers and production users avoid mismatches and unexpected rejections. The real-world consequence is fewer delays and greater control during all stages: from R&D bench work to scaling for market.
Production of Phenacemide brings responsibility beyond technical success. Workers in tablet, capsule, or injectable drug formulation rely on material transparency. By overseeing the entire production chain, we keep allergen risks, cross-contamination, and mislabeling out of the picture. In regulated environments, these seemingly small factors make the difference between smooth audits and recurring headaches.
Our product documentation includes detailed analytical data, complete batch history, and clear, honest reporting of origins and processing aids. We do not shy from disclosing solvents, reagents, or timelines involved in its making. For many customers, this level of disclosure translates into faster, less-painful regulatory submissions.
The business of fine chemicals has changed over the decades. In the early years, inconsistent lot quality and uncertain purity regularly stopped projects in their tracks, costing both time and trust. We learned, through direct losses in our own projects, that thorough process validation pays off over and over. That is why we devote so much attention to equipment maintenance, skilled operator training, and modern analytical instrumentation.
One of the most common issues clients report with other sources involves variable moisture, hidden degradation, or off-odors that trace back to improper storage or shipping delays. This risk multiplies when products pass through intermediaries who can’t guarantee rapid movement or ideal storage conditions. Our operation skips those steps, moving Phenacemide directly from our facility with controlled packaging and shipping. Temperature and humidity monitoring play an everyday role because we’ve watched good product turn bad from neglect at this critical stage.
Across the years, supply chain disruptions—be it port closures, raw material shortages, or new customs inspections—have challenged all producers. Since we handle all the major links ourselves, we manage inventory, anticipate potential bottlenecks, and communicate up-to-date shipping forecasts to clients. Building trust on these mundane yet vital details creates smoother, more reliable deliveries. Large projects thrive on this dependability.
Clients tell us that transparency about product origin and handling gives them the confidence to move forward with scale-up and regulatory filings. Because we control and document every step, we answer detailed traceability and quality queries quickly—no need to defer to external warehousing, brokers, or third parties for answers. Skilled staff and real records match every customer request, which matters most during audits or investigations after a deviation elsewhere in the supply chain.
Our staff participate in regular continuing education and industry conferences to keep up to date. Analytical methods and regulatory expectations shift over time. By staying engaged, we don’t just meet older compendial requirements: we anticipate new standards, validate updated test methods, and remain responsive to shifting regulatory or market signals. Being rooted in the actual work brings resilience when complications arise.
In recent years, authorities have demanded more—from sustainability efforts in production to advanced analytical documentation. As the entity making Phenacemide, we see these demands as a call to sharpen operations. Waste management receives close attention. Solvent recovery is now integrated into many process streams, reducing both costs and environmental impact.
Our regulatory affairs and production teams collaborate daily on the practical steps required to maintain compliance with evolving rules. From filing DMFs (Drug Master Files) to proactively assessing risks from trace impurities, we perform the heavy lifting so our clients don’t shoulder surprise burdens down the road. The trust we build through these efforts directly supports new product approvals, ongoing inspections, and renewal of drug registrations for our clients.
Years of manufacturing experience show that every process has room for refinement. Our line operators and lab staff spot inefficiencies or minor inconsistencies before they grow into supply problems. Feedback from downstream users shapes our process tweaks, whether that means adjusting sieve mesh, altering drying times, or introducing additional in-process controls.
We allocate resources for ongoing equipment upgrades, digital documentation, and enhanced in-process monitoring. These investments are not abstract—they answer practical challenges observed on the floor. For instance, investment in real-time process analytics lets us catch deviations before they reach the packaging stage. That step has stopped more than one costly product recall.
Open communication with clients matters here, too. Direct feedback—like requests for adjusted particle size or modified packaging—feeds our improvement cycles. By manufacturing and shipping within our own system, we turn these requests around rapidly, avoiding the bureaucratic layers that slow change at third-party distributors.
Some buyers focus on price; others stress technical properties. After many cycles in the industry, we see consistent themes: reliability, documentation, and supply assurance are interlinked. An apparently small issue—moisture content, poorly labeled packaging, or slow communication—can delay launches or put licenses at risk. By investing in our own analytical capacity and on-site quality team, we keep these risks in hand and deliver a product others can build upon.
Many competitors lack the on-site resources for deep investigation if something unexpected appears. With full control over raw material origins, in-house analytics, and a staff experienced in multi-ton scale campaigns, we respond to issues without delay. These factors lead to fewer recalls, less rework, and a clearer path for end users to advance projects.
Our journey has benefited from active customer listening. Researchers bring back stories from the bench—points where handling, material behavior, or shipping arrangements impact their work. Their input has driven us to develop more robust packaging, pallets that withstand long-haul shipment, and methods for rush orders when clinical timelines depend on it. With the entire chain inside our operation, meeting these practical requirements does not add extra complication.
Customers value quick, clear answers about process changes or documentation. By keeping technical and regulatory staff in-house, we speed up support for validation or new registrations. These details, collected over years of fielding requests, shape our product to meet the often unspoken needs of pharma, biotech, and industrial users pushing boundaries with Phenacemide.
As regulatory requirements grow more complex and demand for quality rises, we take each challenge personally. Integrated production, full analytical transparency, and a skilled workforce set the foundation for resilient business partnerships. While the details shift, the grounding insight remains the same: skill at every stage—reaction, purification, packaging, and support—makes the difference between a good product and genuine progress in product development. We stand ready for these challenges because every batch of Phenacemide represents not just a finished compound, but years of accumulated skill, investment, and shared experience with our clients.
With new uses for Phenacemide emerging, especially as research unlocks additional anticonvulsant pathways, the market expects higher demands on product quality and documentation. Our experience shows that nimble manufacturing, clear communication, and forward-thinking lab work keep our clients ahead in both speed and compliance. As research and technology evolve, our team regularly revisits both production methods and customer interfaces. This effort is not a response to market pressure; it is a commitment shaped by years walking the plant floor, answering technical calls, and solving day-to-day problems for those on the front line of scientific discovery.
Phenacemide, manufactured by us, means more than just molecular purity. Every shipment stands on decades of production expertise, a clear-eyed commitment to transparency, and responsiveness to real needs in labs and manufacturing plants. Our clients’ work—and their success—depends on that promise, batch after batch.