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HS Code |
232591 |
| Chemical Name | Sodium 4-Phenylbutyrate |
| Synonyms | Sodium phenylbutyrate, Buphenyl, 4-Phenylbutyric acid sodium salt |
| Molecular Formula | C10H11NaO2 |
| Molecular Weight | 186.18 g/mol |
| Cas Number | 1716-12-7 |
| Appearance | White crystalline powder |
| Solubility In Water | Freely soluble |
| Storage Temperature | Room temperature (15-25°C) |
| Therapeutic Use | Treatment of urea cycle disorders |
| Route Of Administration | Oral |
| Mechanism Of Action | Ammonia scavenger through alternative pathway excretion |
| Ph Of 1 Percent Solution | Approximately 7.5-8.5 |
| Stability | Stable under recommended storage conditions |
| Melting Point | 124-126°C |
| Expiration Period | Typically 2-3 years |
As an accredited Sodium 4-Phenylbutyrate factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | Sodium 4-Phenylbutyrate, 100g, packaged in a sealed, amber glass bottle with a tamper-evident cap and clear labeling. |
| Shipping | Sodium 4-Phenylbutyrate is shipped in tightly sealed containers under ambient temperature conditions. It is classified as non-hazardous but should be protected from moisture and incompatible substances. The packaging ensures limited exposure to air and contaminants. Standard documentation for chemical transport is provided, complying with regulatory requirements for laboratory and industrial chemicals. |
| Storage | Sodium 4-Phenylbutyrate should be stored in a tightly closed container in a cool, dry, and well-ventilated area, away from incompatible substances such as strong oxidizers. It should be kept at room temperature, protected from moisture and light. Ensure proper labeling, and avoid exposure to excessive heat or humidity to maintain its stability and efficacy. |
Applications of Sodium 4-Phenylbutyrate in Industrial ManufacturingSodium 4-Phenylbutyrate enables high-value functionality in specialized downstream industrial sectors. As the original manufacturer, we supply this key intermediate to multiple regulated processes where its properties support critical roles in compliance, formulation, and process integration. 1. Active Pharmaceutical Ingredient (API) Synthesis: Urea Cycle Disorder TreatmentsSodium 4-Phenylbutyrate is widely utilized as an API in the formulation of medicines for managing urea cycle disorders, particularly for pediatric and adult metabolic indications. Pharmaceutical manufacturers incorporate it during late-stage synthesis, where purity and controlled particle size significantly impact product stability and bioavailability. Regulatory authorities enforce strict standards governing active pharmaceutical production, including detailed control over impurity profiles, residual solvents, heavy metals, and microbial contamination. Engineers integrate the raw material into dedicated GMP lines, performing in-line analytical monitoring to ensure batch-to-batch consistency before aqueous solution compounding and sterile packaging. Final medicinal products are formulated as oral tablets or liquid solutions, often requiring further steps such as taste masking and controlled dissolution profiling. Industry compliance standards
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2. Oncology: Histone Deacetylase Inhibitor Precursor ManufactureIn the oncology sector, chemists employ Sodium 4-Phenylbutyrate as a precursor when synthesizing a range of class I and IIa histone deacetylase (HDAC) inhibitors. Its role as a butyrate moiety donor is central to generating molecules for preclinical and clinical candidates in solid and hematological tumor studies. Process development teams optimize synthetic routes to control regioselectivity, minimize environmental impact, and achieve strict residual solvent benchmarks. Downstream, integration occurs within a protected handling system involving multi-step organic synthesis, followed by high-performance purification and crystallization. All manufactured intermediates and finished substances undergo extensive analytical release testing and documentation for investigational medicinal product dossiers. Industry compliance standards
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3. Pharmaceutical Excipient: Ammonia Scavenger FormulationsManufacturers of formulations for hepatic encephalopathy, hyperammonemia, and related disorders employ Sodium 4-Phenylbutyrate as an excipient-grade ammonia scavenger. Its high solubility and pH buffering capacity support safe and effective blending with other actives and nutritional aids. During automated blending, the excipient integrates seamlessly via high-shear mixers into solid or solution matrices, followed by direct compression, granulation, or sterile filtration as required by the finished dosage form. For international supply, compliance with health authority monographs and stringent cGMP lot release are mandatory, involving robust material identification, trace metal analysis, and stability studies under controlled humidity and temperature. Industry compliance standards
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4. Rare Disease Therapy: Inborn Errors of Metabolism (IEM) CompoundsSodium 4-Phenylbutyrate is a critical compound in the manufacture of rare disease therapeutics treating inborn errors of metabolism, such as certain hyperammonemia syndromes and related genetic enzyme deficiencies. Specialists in orphan drug manufacturing dose it with exceptional accuracy, as minor deviations can impact efficacy or safety profiles. The production involves sterile line segregation, full chain-of-custody documentation, and real-time NIR (near-infrared) verification for identity and content uniformity. Both oral and parenteral dosage forms require low bioburden input batches and ultra-low endotoxin levels, supporting expedited regulatory review and post-market pharmacovigilance obligations. Industry compliance standards
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Sodium 4-phenylbutyrate, commonly known as PBA-Na, stands out as a vital compound across pharmaceutical and research sectors. Speaking as a company that synthesizes this product from the ground up, every batch we deliver reflects relentless focus on structure purity and traceability. The journey starts with raw material selection. Only high-grade reagents enter our process, ensuring nothing impairs purity. With modern equipment and seasoned operators, quality checks take place at every step, not just at the end. This kind of active oversight marks the difference between a producer who understands the intricacies of the molecule and a distant distributor who relies on third-party quality claims.
Our sodium 4-phenylbutyrate comes in crystalline powder form. Moisture control matters, so each package leaves the facility with secure sealing and thorough documentation. The product sports a standardized appearance: white to off-white, free from visible contaminants. Specification sheets report purity consistently above 99%. Such high assay figures come directly from HPLC, not only from reliable suppliers but from the instruments in our own labs. The lot-specific data goes onto every shipment. Research clients in chemical synthesis count on this because every stray impurity can alter outcomes, introduce unwanted variations, or demand costly adjustments downstream.
Large-scale production allows us to serve both pharmaceutical manufacturers and advanced academic researchers. The main application for sodium 4-phenylbutyrate has grown in the rare disease medication sector, where accurate dosage and high purity compete with stringent regulatory oversight. Several approved therapies rely on this compound to help manage urea cycle disorders. The chemical structure supports ammonia detoxification, a key factor in treating cases where natural metabolic cycles falter.
Our clients include pharmaceutical laboratories, hospital research groups, and contract manufacturing organizations. These groups request sodium 4-phenylbutyrate as a bulk API, as well as piloting precursor studies or toxicology reports. For these users, product provenance matters as much as the assay numbers: documentation trails, batch release records, and transparent supply chains build the trust that their own industry certifiers demand.
In our experience, consistency of supply matters almost as much as purity. Delays or unpredictability introduce real risk to time-sensitive production schedules. Keeping the synthesis entirely in-house, we manage lead times directly. Emergency re-runs or recalibrations can be handled in days, compared with weeks at facilities reliant on outside blending or repackaging. Supply chain predictability makes scaling trials and onboarding new clients much easier for the end-user, who rarely sees these mechanics in play but feels the effect through reliable restocking.
Maintaining a quality-controlled environment builds the foundation for safer chemical manufacturing. Automated environmental controls, continuous air filtration, and strict personnel protocols make impurity drift unlikely. Routine staff training, from lab technicians through maintenance, means that potential human error is spotted and corrected before it snowballs into a quality issue. Every deviation, no matter how minor, is investigated and documented for long-term process improvement.
Chemical distributors or brokers often lack direct oversight, relying instead on reports that may be out of date, or samples that do not represent the real batch. With direct manufacturing, the story changes entirely. Variability drops significantly, since process conditions are not left to chance or guessed at from incomplete documentation. For users ordering sodium 4-phenylbutyrate across multiple projects or fiscal quarters, minimizing these discrepancies matters. A product that meets specification one month but deviates the next brings unpredictable performance, wasted labor, and potential regulatory headaches as records pile up.
Competitors sometimes deliver repackaged goods, which creates uncertainty around origin, documentation, or contamination risk. Sourcing direct means a closed loop: the plant, not an anonymous warehouse or handling center, has custody over each shipment. To outsiders, this may seem minor; to anyone who has had a handful of problematic lots disrupt a full-scale production run, the difference is clear.
We keep transparent batch histories, tracking everything from starting inventory to final shipment. Customers never have to question the source or identity of their purchase. Many seasoned professionals will recall batch inconsistencies or supply gaps from third parties. Those failures often stem from sellers lacking their own infrastructure. We keep gaps and mishaps rare by running our own reactors, calibrating our own equipment, and documenting our own protocols.
The story of sodium 4-phenylbutyrate's production involves more than chemical equations or datasheets. Real plant conditions differ from textbook syntheses. Moisture sensitivity, for instance, increases risk in humid climates. To combat this, we opted for air-locked storage and rapid sealing as soon as the drying step finishes. Personnel training focuses on practical challenges, such as minimizing product exposure and identifying off-odors that signal early-stage contamination. Every technician knows that product going to a GMP pharmaceutical plant must meet higher standards than bulk feedstock.
Scale also shapes quality. Small-batch synthesis can sometimes allow tweaks or last-minute fixes, but larger reactors demand zero-tolerance for error. Our operators log every in-process observation, cross-check instrument readings, and halt the line when anomalies appear. These habits, ingrained by years of managing both minor and large lots, push our quality higher than bulk compounders who prioritize volume over consistency.
Sodium 4-phenylbutyrate used in pharmaceuticals faces intense regulatory oversight. From the first customer inquiry, we supply full documentation: batch certificates of analysis, process validation records, and impurity profiles. Each order carries traceable documentation from starting materials through finished lot, meeting global regulatory frameworks. When importing or registering new medicines, drug sponsors need not chase down missing paperwork or risk regulatory delays caused by incomplete supply chain mapping. Taking the time to maintain these records on our end clears the path for partners to push ahead with their own submissions, audits, or compliance reviews.
Long-term contracts often require stability studies and extended retention of archived samples. Our procedure holds reference samples from every lot for two full years under controlled conditions, ready to support post-marketing reports or unexpected testing. Having handled multiple regulatory audits at both local and foreign levels, we understand the extra scrutiny that sodium 4-phenylbutyrate invites as a direct treatment ingredient. Our documentation is always up to date, eliminating the back-and-forth that can drag on for weeks in less organized supply chains.
Listening to regular plant operators or technical managers, one hears more about simple packaging slips, contamination risk, or long lead times than high-level management tends to realize. Many came to us after struggling with crushed package liners that compromised whole shipments or inconsistencies that threatened line testing. Acting on this feedback, we upgraded packaging to resistant multi-layer polyethylene bags inside sealed drums—an approach that mostly eliminates transit damage.
Clients in formulation labs mention concerns about fine particle distribution and settling. We tuned our milling steps to deliver a median particle size that balances easy suspension with minimal dust-off risk. The reduced static and improved pourability, while minor to outsiders, bring day-to-day advantages on the production floor. Those changes came straight from technician suggestions during early customer site visits, not from remote analyst predictions.
Looking across the market, production methods for sodium 4-phenylbutyrate differ widely. Some rely on outdated batch reactor setups, bringing higher risk of cross-contamination or batch-to-batch drift. Others skip important purification steps to compete on cost, but this shortcut risks introducing contamination from solvent residues or byproducts.
Our process maintains pressure on both cleanliness and repeatability. We use a closed system with continuous in-line monitoring. Automated sampling for each production lot means issues can be identified before product is transferred for packaging. By integrating more analytics and less manual sampling, we reduce error rates and ensure that customers receive what they expect every time.
A direct control over synthesis lets us test improvements rapidly. Over the years, we eliminated a legacy solvent in our process after industry studies identified potential long-term impurity buildup. Transparency in ingredient sourcing becomes more difficult when companies blend incoming material from different sites—a challenge we sidestep entirely by vertical integration.
Anyone running a chemical plant knows that handling sensitive materials such as sodium 4-phenylbutyrate requires more than just a good synthetic route. Personnel training covers loading and unloading, as well as spill response and real-time monitoring of storage conditions. Incorrect handling might affect product performance even before it leaves our facility. Picking the right container, scheduling rapid shipment, and choosing logistics partners who avoid lengthy trans-shipments keeps the product in ideal condition up until it reaches the end user.
We designed storage protocols with both high-volume and small-lot needs in mind. Bulk orders move in lined drums with high moisture barriers. Small-parcel research lots ship double-bagged with desiccant pouches, boxed for extra security. By tracking all storage conditions on-site, and providing storage advice for downstream users, we support a chain of custody that limits product loss. For example, we log temperature and humidity status of our storage rooms, extending those same best practices in our client support material.
Compliance never takes a back seat at our plant. Each incoming shipment of starting material is scanned, sorted, logged, and quarantined for identity confirmation by IR and NMR. Only authenticated feeds make it into the main production line. Plant staff monitor production rooms for any mis-labeling or storage error. These habits grew out of past near-misses, where even minor errors in labeling created hours of catch-up work for quality control staff downstream.
Every lot released has gone through third-party independent analysis, along with our own internal QA checks. We store audit trails digitally and physically: a practice that saved multiple customers from regulatory delay during spot-checks or surprise compliance requests. Having seen partners get set back by missing data from intermediary suppliers, we know the peace of mind a full document trail brings to end-users who have little time to chase their own paperwork.
Looking at the sodium 4-phenylbutyrate industry, several challenges remain common. Supply interruptions due to geopolitical risk or transport failure can impact production downstream. Running our own sourcing and maintaining larger-than-average finished goods inventory cushions these shocks. Whenever possible, we diversify our raw materials base—building redundancy into the sourcing chain.
Another recurring risk involves hidden impurities, or product "cutting" that can defeat high-stakes pharmaceutical processes. By standardizing direct-instrument analysis for every lot—HPLC, GC-MS, and moisture—we block these risks before they reach the warehouse. While some competitors skip analytics for cost, our policy means absorbing higher routine QC expense in exchange for fewer customer complaints.
Tightening global regulations bring more paperwork with every passing year. We support users by preemptively updating our batch records and making them accessible for client audits. In difficult situations, such as product recalls upstream, our clear tracking lets us trace products from final shipment back to every drum and sample vial.
Users in manufacturing often face problems that don't show up on technical specs. They may see unusual settling, struggle to suspend residual dust, or encounter unexpected interactions in formulation work. Our technical team deals with those issues directly, sometimes traveling to major client sites to observe daily processes and recommend practical fixes. Suggestions such as upgrading ventilation during open handling or introducing low-shear mixing protocols grew from such site visits, not theory alone.
Direct feedback has led to iterative process changes on our end, like fine-tuning drying temperatures to limit degradation. Instead of offering a standard bulk product, these adaptations come as part of a direct manufacturing partnership—distinct from the noncommittal support that resellers provide. Anyone who has watched a critical timeline slip due to lack of actionable support knows the value this brings to long-term relationships.
Years of manufacturing sodium 4-phenylbutyrate have taught us that product quality is only the beginning. Customers want certainty—knowing that a given batch works exactly the same as the last, and that unexpected hurdles won’t turn into days of lost production. By taking full control of the process, from synthesis through storage and shipment, we meet this need head-on.
Improving transparency on our side helps end-users succeed with regulatory filings or scale up confidently. A deep understanding of our customers’ routines, pain points, and compliance needs drives continued investment in the plant, documentation, and support teams. Direct oversight not only tightens process control, it also creates a relationship of mutual trust grounded in real performance, not just stated compliance.
Trends in rare disease treatment, demand for more traceable APIs, and the ongoing push for higher purity keep raising standards. Manufacturing sodium 4-phenylbutyrate at scale challenges us to maintain strong foundations while continually improving the process and adding value. Listening to user feedback, adapting plant procedures, and staying ahead of compliance requirements forms the backbone of true progress in chemical manufacturing. As a company that makes the product, instead of just selling it, responsibility for every lot rests with us until our partners have run their final tests and put their own name behind a finished product.
That commitment strengthens the industry's progress and sets direct manufacturers apart as reliable, long-term partners in a changing world.