Tengfei Creation Center,55 Jiangjun Avenue, Jiangning District,Nanjing admin@sinochem-nanjing.com 3389378665@qq.com
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Oxiracetam

    • Product Name Oxiracetam
    • Alias ISF 2522
    • Einecs 63121-00-6
    • 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
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    Specifications

    HS Code

    375360

    Chemical Name Oxiracetam
    Cas Number 62613-82-5
    Molecular Formula C6H10N2O3
    Molecular Weight 158.16 g/mol
    Appearance White crystalline powder
    Solubility In Water Highly soluble
    Melting Point 163-164 °C
    Classification Nootropic (racetam family)
    Route Of Administration Oral
    Half Life 8 hours
    Mechanism Of Action Modulates glutamatergic and cholinergic systems
    Storage Conditions Store in a cool, dry place

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

    Packing & Storage
    Packing Oxiracetam is packaged in a sealed, opaque 100g plastic bottle with a tamper-evident cap and clear labeling for identification.
    Shipping Oxiracetam is shipped in tightly sealed, airtight containers to prevent contamination and moisture exposure. It is packaged according to international regulations for chemical substances, typically labeled as a non-hazardous research chemical. Shipping includes temperature control if required, safety documentation, and compliance with all relevant transport guidelines for safe delivery.
    Storage Oxiracetam should be stored in a tightly sealed container, protected from light, moisture, and air. Keep it at room temperature, typically between 20–25°C (68–77°F), and away from direct heat or humidity sources. Store in a dry, well-ventilated area, separate from incompatible substances. Ensure the storage location is secure and out of reach of children and unauthorized persons.
    Application of Oxiracetam

    Applications of Oxiracetam in Industrial Manufacturing

    As a committed producer of Oxiracetam, we supply bulk-grade material for regulated downstream sectors where established, large-scale applications demand strict adherence to industry protocols. Our production supports enterprises working with functional formulations for approved purposes, with processes optimized for accuracy and batch consistency. Below, we outline core industrial segments utilizing Oxiracetam, emphasizing real-world deployment parameters in each field.

    1. Pharmaceutical Finished Dosage Manufacturing

    Oxiracetam serves as an active pharmaceutical ingredient (API) in the formulation and scaling of ready-for-tablet, capsule, or powder products targeting recognized indications in cognitive health. Manufacturers working in this area must meet the stringent compliance measures for APIs, from procurement to finished dosage, maintaining full transparency across the batch manufacturing cycle and performing routine validation on blending, granulation, and compressing steps. Decisions regarding inclusion rates, excipient pairing, and blending timings are made to meet pharmacopoeia purity and identity criteria, as required for regulatory submission.

    Industry compliance standards

    • ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
    • US FDA 21 CFR Part 210/211: cGMP for Finished Pharmaceuticals
    • EU GMP Guidelines (Part I, II), Annex 13 for IMPs (if applicable)
    • Compendial requirements: EP, USP, JP Monographs when applicable

    Typical usage ratio

    • Standard API loadings range from 200 mg to 1,200 mg per solid unit. Overall formula percentage depends on the finished dosage strength; Oxiracetam usually makes up 40–80% of the tablet/capsule matrix, with excipients adjusted for flow, compressibility, and API concentration per therapeutic guidelines.

    Downstream process integration

    • Enters as crystalline or micronized API during direct blending, wet granulation, or dry granulation depending on formulation requirements. Quality control checks occur at raw material intake, in-process blending, tableting, and coating stages to confirm API distribution and dissolution properties.

    Final product types

    • Uncoated or film-coated tablets
    • Hard gelatin capsules
    • Unit-dose oral powder sachets
    • Bulk bottle-packaged generics for hospital/retail pharmacy supply

    2. Bulk API Formulation for Third-Party Repackagers

    Commercial repackagers and contract manufacturers source Oxiracetam in industrial bulk for further handling under validated cleanroom and packaging conditions. The supply chain involves rigorous traceability from primary production through secondary repacking into standardized containers destined for regional distributors or institutional buyers. Compliance with traceable batch records and serialized labeling forms a critical part of this workflow, with repackaged bulk intended for direct hand-off to downstream registered entities for final compounding or end-use.

    Industry compliance standards

    • WHO GMP and GDP (Good Distribution Practice)
    • ISO 9001:2015 Quality Management for Packaging Operations
    • National pharmacovigilance traceability rules (e.g., China DMF/NMPA, EMA, US DSCSA serialization, if exported)

    Typical usage ratio

    • Packed at 98.0–99.0% pure Oxiracetam, with batch size ranging from 1 kg up to 20 kg drums; minor inert stabilizers (≤2%) may be included as per the receiving customer’s regulatory file.

    Downstream process integration

    • Bulk material is repacked into smaller unit containers (100g–5kg) under class 10,000 cleanroom conditions; all batch aliquots undergo QC identity, moisture, and particle size checks before labeling and release.

    Final product types

    • Bespoke API kits for hospital compounding
    • Smaller vials for research and stability testing
    • Ready-to-use GMP lots for licensed third-party packaging
    • Custom lot repacks for government/pharmaceutical supply auctions

    3. Clinical Trial Manufacturing (Investigational Medicinal Product Supply)

    Clinical research organizations and pharma manufacturers require Oxiracetam as an investigational medicinal product (IMP) for controlled trials involving cognitive enhancement compounds. IMP production mandates adherence to clinical batch controls, source validation, blinding procedures, and a chain of custody strictly monitored for protocol compliance. Batch release for clinical supply includes complete analytical method validation and retest under ICH stability guidelines.

    Industry compliance standards

    • ICH Guideline E6(R2): Good Clinical Practice
    • EU Clinical Trials Regulation No 536/2014
    • Annex 13, EU GMP for IMPs
    • US FDA IND requirements (21 CFR Parts 312, 320)

    Typical usage ratio

    • IMP capsules/tablets usually contain 200–800 mg per unit, formulated as per approved trial protocol; placebo and active batches are prepared in matched capsules, with API representing the only pharmacologically active component.

    Downstream process integration

    • API weighed, milled, and mixed in GMP manufacturing suites; units are blind-packaged, serialized, and placebo-matched under double-blind or crossover study requirements. All process steps are batch-recorded and cross-checked by a qualified person (QP) before release to study sites.

    Final product types

    • Study-labeled capsules/tablets for phase I/II clinical trials
    • Randomized blinded IMP kits (case/patient specific)
    • Comparator batch packs for hospital-based research
    • Test/retention samples for regulatory audits

    4. Nutritional Supplement Production (Where Permitted by Law)

    Some jurisdictions authorize the use of Oxiracetam in manufacturing cognitive dietary supplements, subject to local health authority regulations on non-prescription use. Production involves large-scale blending of the raw material into multi-component nutritional powders or single-ingredient capsules, with particular attention to ingredient assay, uniformity, and particulate control. Finished goods must be labeled, marketed, and distributed in conformance with precise labeling and composition standards—all under regular regulatory inspection programs.

    Industry compliance standards

    • GMP for Dietary Supplements (21 CFR Part 111, if US)
    • EFSA/Food Safety Authority guidance (if EU)
    • Local health and food regulatory authority approval (jurisdiction-dependent)
    • ISO 22000:2018 (Food Safety Management, voluntary)

    Typical usage ratio

    • Dose typically ranges from 100 mg to 800 mg of Oxiracetam per capsule or per 5-gram serving in compounded nutritional blends; inclusion depends on target serving size and formula blending limits, adjusted for legal daily intake maximums and regional supplement guidelines.

    Downstream process integration

    • Material enters the blend process after QA release, mixed with other approved supplement ingredients in ribbon blenders or paddle mixers; product passes through sieving, encapsulation, or sachet filling, followed by in-process testing for content uniformity and finished batch microbial screening.

    Final product types

    • Bottle-packed single-ingredient capsules (where legal)
    • Multi-ingredient cognitive support powders/beverage mixes
    • Sachet-packed “brain health” granules (where regulations allow)
    • Sample kits for registered dietary supplement retailers
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    Certification & Compliance
    More Introduction

    Oxiracetam – Insight from the Manufacturer’s Production Line

    Daily Experience in Manufacturing Oxiracetam

    Every day on the plant floor, I see Oxiracetam crystals pour through our final centrifuge. The white powder catching the light looks simple, and the chemical name—4-hydroxy-2-oxo-1-pyrrolidine acetamide—is long enough to feel like something reserved only for expert chemists. Yet, Oxiracetam is a product that blends complex science with practical benefits. Our staff tracks every reaction step, monitoring temperature, pH, and purity, because consistency matters to everyone down the supply chain. As the actual manufacturer, I know every batch of Oxiracetam carries our reputation and the trust of our partners, whether they use it in research or for making brain health products.

    From Synthesis to Finished Product: What Goes Into Oxiracetam

    Oxiracetam belongs to the racetam class, a group of compounds appreciated for their impact on cognitive functions. The production starts with a base compound—2-pyrrolidone—and runs through a series of tailored chemical reactions in a controlled reactor. On our line, trained operators work with automated dosing, monitored oxidation steps, and filtration units designed to remove unwanted by-products. Each stage is critical. If the temperature spikes or the catalyst isn’t right, you get side products—we never release anything before running a complete chromatographic check for impurities and confirming the final assay meets specification.

    Most research and supplement manufacturers order Oxiracetam in pharmaceutical grade, aiming for purity above 99%. We rely on multi-stage recrystallization and advanced drying units to lock in that consistent high quality. Moisture and residual solvents are checked, with real numbers: less than 0.5% moisture content and negligible heavy metals, using mass spectrometry and HPLC. When you open a drum from our facility, you can expect a fine, odorless, tasteless powder that flows freely and dissolves as required.

    Why Specifications Matter: Details from the Lab Tests

    Oxiracetam specifications are not just paperwork—they are the backbone of our long-term partnerships. Each batch undergoes identity testing to confirm the correct isomer is present. We measure melting point, particle size distribution, moisture, and purity. Typical lot analysis in our lab shows an assay of 99.3% with less than 0.1% residual solvents.

    End users rely on this: pharmaceutical companies need a reproducible product for clinical trial materials, research labs demand a compound that won’t introduce unknown variables, and nootropic formulators require smooth blending for consistent capsules or sachets. Failing on heavy metals testing, or bacterial contamination, means an expensive recall and breaks trust. We use certified equipment for heavy metal screens—no batch leaves the plant before we see a ‘pass’ under 10 ppm.

    Some customers require documentation for allergens or cross-contamination. Our lines run Oxiracetam as a dedicated process to avoid even trace mix-ups. Operators stick to strict SOPs, and we log every cleaning cycle to back up our claims. This kind of hands-on control comes only from doing the chemistry ourselves, not repackaging someone else’s bulk lots.

    Oxiracetam vs. Other Racetams: Direct Comparisons from Production

    As the manufacturer, I have worked with a whole suite of racetams: Piracetam, Aniracetam, Pramiracetam, and Phenylpiracetam. Each runs on its own chemistry, equipment, and environmental controls. Oxiracetam stands out by its stability and handling ease. For example, Aniracetam often has an odor of slightly bitter almonds—some end users dislike that. Pramiracetam feels oily and clumps, forcing us to split batches and add anti-caking steps during drying. Phenylpiracetam remains sensitive to temperature and can degrade faster, especially in large drums. In contrast, Oxiracetam always produces consistent, powdery lots requiring only standard moisture control and minimal post-processing.

    On the molecular level, Oxiracetam’s hydroxy substitution gives it greater water solubility than most of its peers, which benefits downstream formulators who work with aqueous solutions. Researchers using neural models report that Oxiracetam’s structure allows simpler analysis in pharmacokinetic assays. Unlike Piracetam, which sometimes needs denser packaging to prevent settling, Oxiracetam’s powder maintains even flow after months on the shelf.

    End Applications: Supporting Safe and Reliable Use

    Oxiracetam’s main end use lies in cognitive enhancement and neuroscience research. Beyond its lab value, it features in cognitive supplement lines and, in certain countries, prescription drug formulations. We understand the responsibility inherent in producing substances that end up in human health products. The tighter the specifications and the greater the documentation, the easier it is for downstream users to trust the results of their clinical trials or submit their applications to regulators.

    Our direct clients always ask not just for a product but for the full lot history, detailed CoAs, and sometimes even samples from retention to cross-check our own work. We produce stability data, not out of regulatory obligation, but because we want our business partners to see real shelf-life performance. Oxiracetam holds its potency at room temperature for years, which we verify with periodic re-testing of stored reference samples. We do not just quote shelf stability—we document it.

    Common Questions and Quality Challenges: Our Perspective

    Every few weeks, a new customer asks whether Oxiracetam is really synthetic, or if conversion from natural sources is possible. In our experience, all commercial-scale production relies on controlled chemical synthesis from base intermediates. We avoid unnecessary side reactions by fine-tuning catalysts and holding every reaction step in the optimal range—temperature, pressure, and solvent.

    Purity questions often follow. Since the compound sees use in nootropics, off-flavors or poorly soluble batches will be noticed at once. Feedback from both research teams and product manufacturers has shown that even small differences in moisture or particle size affect flow and dosing in capsule fills. Our plant has upgraded dry rooms, and since we can adjust the milling process, we deliver the mesh size suited for end use. We do not release lots with visible clumping or excessive fines.

    Products sourced from traders sometimes go wrong: inconsistent purity, high moisture, degraded color, or heavy solvent residue. As original manufacturers, we adjust our process every time a deviation occurs, logging what happened and fixing root causes. Temperature excursions, poor filtration, or miscalculation in reagent dosing get traced, and we discard any batch that does not meet our published specification.

    Sustainability and Responsible Practice in Production

    Running a full-scale Oxiracetam line means managing chemistry and environmental impact together. Chemical waste handling is a daily part of our job, not just an afterthought. Operators track all solvent streams, run evaporation and recycling steps, and separate hazardous waste before it ever leaves the plant. We invest in filtration and scrubber technology for air releases and keep water effluents clean.

    Any lab can make small-batch Oxiracetam, but scaling up in the real world brings risks of environmental load and operator safety. Our plant uses closed-loop systems where possible, recovers and neutralizes acidic and basic by-products, and keeps emissions well below legal limits. Auditors from international partners review our data, tour our lines, and inspect our maintenance logs because environmental compliance and safety make long-term sense for our staff, customers, and the brand itself.

    We also keep up with changing global requirements. Some international authorities now require full documentation on every process step, including trace solvent origins and intermediate testing. We have invested in new digital tracking—every drum’s history can be traced from raw material source to the finished product, which helps answer supply chain questions before they even arise.

    Supporting Innovation: Collaborative Development and Feedback

    As a manufacturer, we keep one foot in production and the other in partnerships with R&D teams. Sometimes a new customer comes in with feedback from their own product tests—maybe they need finer particle sizing for rapid dissolution, or an ultra-high purity for laboratory standards. We work directly with technical teams to adjust process parameters and even adapt the packaging line to minimize static, clumping, or cross-contamination. This hands-on approach often means small batch re-runs or pilot tests until our customer’s analytics confirm the desired outcome.

    Our chemists enjoy these challenges. They spend time in the QC lab, running HPLC and NMR machines, tweaking synthesis steps, and sharing progress in full technical detail. We keep open records of every meaningful process change. These details get shared, not hidden. In the last year, a university collaborator needed low-sodium lots for special animal models—we found a way and now offer this as a new option.

    Safe Handling and Product Stewardship

    Our experience in Oxiracetam production goes beyond technical parameters. Protecting downstream users—whether they are lab researchers, capsule bottlers, or clinical teams—drives every change on the plant floor. We insist on strong batch traceability not just to meet rules, but to support investigations whenever an anomaly or product question arises. If a lot ever reports an out-of-range result, we pull remaining drums, analyze reference samples, and support the customer with root-cause findings. These policies come from years of direct experience, not just regulatory book learning.

    Safe handling also means supporting clear instructions on storage and transport. Our drums feature desiccant packs, tight secondary closures, and easy-to-read batch codes. Each shipment leaves our facility with backup samples kept for two years. If a customer reports anything unusual, we can cross-test and reconstruct full batch history. Clients notice this: repeat orders come from the assurance that their product comes with real, reachable process support, not generic statements and handoffs.

    Understanding True Production Costs and Value

    Oxiracetam buyers sometimes wonder why pricing varies so much. The market features intermediaries who shop for lowest-cost material, often with variable quality and missing documentation. As a manufacturer, I see the actual costs: raw materials, energy, labor, advanced equipment for QC, and rigorous environmental safety. Our cost structure includes investment in reliable automation, product-specific reactors, and ongoing maintenance.

    Many clients pursue lowest price, thinking all powders labeled as Oxiracetam are equal. Our experience shows that low-cost batches often come with higher solvent residues, more moisture, or even non-conforming isomer content. These batches fail customer audits, gum up tableting machines, or degrade on long-haul shipments. We see customers return to us after troubles with inconsistent products—cost savings disappear when a batch brings added work, recalls, or downtime.

    Our pricing reflects direct investment in stable operations, clean production, and technical support. End users choosing original source Oxiracetam avoid hidden risks and simplify their logistics, registration, and process validation steps. We prefer long-term partnerships over speculative one-off trades because reliability and transparency benefit everyone.

    Building Trust Through Transparency and Consistency

    Transparency shapes every part of our manufacturing operation. Every client receives a full dossier—lot production dates, process logs, quality control analysis, and stability records. If a regulator or customer needs a deep-dive into a single step, we welcome the scrutiny. We view surprise audits as a learning opportunity, not a threat. This attitude sets apart true manufacturers from those who merely repack or relabel material from varied origins.

    Long experience shows the difference between a direct plant and an assembled supply chain. If a client’s laboratory reports an off-specification result, we support resolution with re-tests, on-site reviews, and immediate feedback. This loop of candid data exchange prevents quality drift and builds the kind of trust that survives shifting market conditions or regulatory waves.

    No manufacturer wins every contract. Fluctuating raw material costs and unpredictable regulations sometimes test our flexibility. We focus on what never changes: honest recordkeeping, scientific accuracy, and proactive communication with every stakeholder. Buyers who value quality and reliability recognize these strengths over time.

    The Future: Continuous Improvement and Industry Responsibility

    Industry changes push us to refine our process year after year. New regulations for data transparency, sustainability, and product traceability set higher expectations for every raw material supplier. We respond by updating our documentation practices, upgrading environmental controls, and training staff to handle new analytical techniques.

    Ongoing dialogue with customers—whether for larger batches, customized grades, or regulatory documentation—spurs technical upgrades. We take feedback seriously: in the last cycle, input from an export partner led us to automate log updates and build quicker digital tracebacks. Our staff partners with suppliers who share our values, pushing for renewable raw material sourcing and greener process chemistry.

    From a manufacturer’s point of view, producing Oxiracetam extends beyond chemistry. It means rigorous daily attention to detail, open communication, honest error correction, and a long-term view toward environmental and regulatory shifts. Through this approach, we support researchers, health professionals, and process engineers with the materials they need to advance their work.