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

Norclobazam

    • Product Name Norclobazam
    • Alias Clobazam
    • Einecs 219-005-4
    • 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
    VTB
    Specifications

    HS Code

    766156

    name Norclobazam
    CAS_number 71326-46-2
    molecular_formula C15H13N2O2Cl
    molar_mass 288.73 g/mol
    IUPAC_name 8-chloro-1-phenyl-1,3,5,10-tetrahydro-2H,3H,5H-benzo[d][2,4]benzodiazepin-2-one
    parent_drug Clobazam
    drug_class Benzodiazepine derivative
    legal_status Prescription only (varies by country)
    primary_metabolite_of Clobazam
    route_of_administration Oral (as metabolite)
    appearance White to off-white powder
    elimination_half_life Importantly long, varies between 30-70 hours
    systematic_name 8-chloro-1-phenyl-1,3,5,10-tetrahydrobenzo[d][2,4]benzodiazepin-2-one

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

    Packing & Storage
    Packing Norclobazam is supplied in a white, tamper-evident 10-gram amber glass bottle with a child-resistant screw cap, labeled with safety information.
    Shipping Norclobazam is shipped in compliance with international regulations for pharmaceutical and research chemicals. It is securely packaged in sealed, labeled containers to ensure safety and substance integrity. Appropriate documentation accompanies each shipment, and temperature control measures are taken if required. Shipping is arranged via certified carriers with tracking for reliable and timely delivery.
    Storage Norclobazam should be stored in a tightly closed container at room temperature, typically between 20°C to 25°C (68°F to 77°F), away from moisture, heat, and direct light. It should be kept in a secure location, out of reach of children and unauthorized individuals, and protected from incompatible substances. Store in accordance with local regulations for controlled substances.
    Application of Norclobazam

    Applications of Norclobazam in Industrial Manufacturing

    As a manufacturer specializing in pharmaceutical-grade Norclobazam, we supply this critical raw material to select downstream sectors which demand highly controlled and compliant synthesis environments. Below we outline primary industrial use cases, emphasizing industry standards, processing integration points, responsible formulation, and final application types within highly regulated domains.

    1. Active Pharmaceutical Ingredient (API) in Anticonvulsant Drug Formulation

    Pharmaceutical companies use Norclobazam as a key active ingredient during the formulation of prescription anticonvulsant medications, addressing seizure disorders such as Lennox-Gastaut syndrome. Bulk Norclobazam integrates directly into solid oral dosage production lines, requiring precise compliance with global pharmacopoeias and stringent quality frameworks in every step from synthesis to tableting.

    Industry compliance standards

    • ICH Q7: Good Manufacturing Practice (GMP) for Active Pharmaceutical Ingredients
    • European Pharmacopeia (Ph. Eur.) Monograph 01/2022:2692
    • U.S. Pharmacopeia (USP)
    • 21 CFR Part 210/211 (FDA Good Manufacturing Practices)

    Typical usage ratio

    • Varies from 5 mg to 20 mg per unit tablet, batch level typically 0.2%–2% w/w depending on targeted dosage strengths and regulatory limits. Adjustment based on therapeutic index and compounding protocol.

    Downstream process integration

    • Introduced at the active blending or granulation phase prior to compression and coating during tablet or capsule manufacturing.

    Final product types

    • Prescription tablets for seizure management (e.g., branded or generic Clobazam alternatives)
    • Pediatric dispersible tablets
    • Oral suspensions for hospital and outpatient use

    2. Reference Standard for Analytical Testing in Quality Control Laboratories

    Pharmaceutical and contract testing laboratories utilize Norclobazam as a certified reference material for method development, validation, and routine batch analysis. Its application ensures accurate quantification, impurity profiling, and regulatory release of finished dosage forms, underpinning batch consistency and market release compliance.

    Industry compliance standards

    • ISO/IEC 17025: General Requirements for the Competence of Testing and Calibration Laboratories
    • USP General Chapter <1226>: Verification of Compendial Procedures
    • Good Laboratory Practice (OECD GLP)
    • European Pharmacopeia Reference Standards policy

    Typical usage ratio

    • Stock solutions typically at 1–10 μg/mL in HPLC/GC-MS analysis; dilutions depend on method sensitivity and analytical scope.

    Downstream process integration

    • Prepared as calibration standards during QC release testing and stability studies of finished pharmaceutical forms; directly used in method performance qualification and impurity monitoring protocols.

    Final product types

    • Certified analytical reference kits
    • Calibration solutions and control samples
    • Validated HPLC/GC assay reference libraries

    3. Intermediate in Custom Synthesis for Central Nervous System (CNS) Research Compounds

    Research-based pharmaceutical development groups and contract manufacturers employ Norclobazam as an intermediate or template molecule in multi-step synthetic pathways to create novel benzodiazepine derivatives for CNS investigation. This use demands tracked batch provenance and adherence to pharma-grade synthesis protocols within restricted access facilities.

    Industry compliance standards

    • ICH Q11: Development and Manufacture of Drug Substances
    • Good Laboratory Practice (GLP) for non-clinical R&D
    • EU REACH Regulation (EC 1907/2006) requirements for research chemicals
    • Controlled Substances Act (21 U.S.C. § 801 et seq.) for Class IV precursors

    Typical usage ratio

    • 0.1–5.0% molar equivalents in multi-step benzimidazole or diazepine scaffolding syntheses; ratio chosen based on downstream structure-activity relationship (SAR) objectives.

    Downstream process integration

    • Fed into protected-stage coupling or amidation reactions, often as the starting scaffold for CNS-active molecular exploration and semi-synthetic library construction.

    Final product types

    • Experimental CNS drug candidates
    • Lead compound libraries for SAR analysis
    • Bioanalytical probes for neuropharmacology pipelines

    4. Ingredient in Stability Study Protocols for Regulatory Submission

    Norclobazam facilitates formal stability assessment within regulatory filing submissions by pharmaceutical clients. It forms part of ICH-compliant forced degradation and stress testing protocols to determine shelf-life, identify degradation pathways, and ensure dosage-form robustness across global climates, integral to product registration dossiers.

    Industry compliance standards

    • ICH Q1A(R2): Stability Testing of New Drug Substances and Products
    • FDA Guidance for Industry: Stability Testing of Drug Substances and Products
    • World Health Organization (WHO) Technical Report Series, No. 953, Annex 2
    • European Medicines Agency (EMA) Guideline on Stability Testing

    Typical usage ratio

    • Full-strength input per dosage label (e.g., 5–20 mg per unit); higher concentrations for forced degradation (up to 10x clinical dose where validated methodological stress is required).

    Downstream process integration

    • Dosed into pilot or validation batches slated for accelerated and real-time stability chambers, monitored through validated chromatographic and spectrometric assays per dossier requirements.

    Final product types

    • Regulatory stability study batches for submission
    • Degradation and stress test panels provided to authorities
    • Batch data packages supporting global marketing authorizations
    Free Quote

    Competitive Norclobazam prices that fit your budget—flexible terms and customized quotes for every order.

    For samples, pricing, or more information, please call us at +8615371019725 or mail to admin@sinochem-nanjing.com.

    We will respond to you as soon as possible.

    Tel: +8615371019725

    Email: admin@sinochem-nanjing.com

    Get Free Quote of Sinochem Nanjing Corporation

    Flexible payment, competitive price, premium service - Inquire now!

    Certification & Compliance
    More Introduction

    Introducing Norclobazam – Reliability Through Experience

    A Look Inside Real Production

    Norclobazam serves a pivotal role in pharmaceutical synthesis, especially for research labs and preparation of certain active compounds. From the manufacturer’s floor, every batch undergoes stepwise synthesis, starting with 2,3-dihydro-1H-1,5-benzodiazepin-4-one. The expertise to keep impurities within strict limits doesn’t stem from marketing claims—it comes from technicians familiar with benzodiazepine chemistry and exacting customers who regularly cross-check identity and purity by HPLC and NMR. What might look like a clean powder to a casual observer actually depends on carefully controlling solvent evaporation, temperature profiles, and preventing cross-contamination. Standard Norclobazam often appears as a white to off-white crystalline solid, usually available at a purity not below 98.5% by HPLC and confirmed structure by full spectral workup. Most requests specify quantities for pilot or mid-scale use, though we’ve handled both small-gram research samples and batches running over 10 kilograms.

    Why Model Choices and Specifications Matter

    In practical terms, nobody wants wasted time on inconsistent lots. Even a difference between 98.5% and 99.5% purity can change downstream crystallization behavior. Our standard model sees heavy demand: it offers clear, low-odor, practically insoluble powder. Beyond purity, water content also plays a role: residual water greater than 0.5% leads to storage problems and changes solubility profiles. It pays to keep Karl Fischer titration under close watch, as high-moisture solid may turn clumpy during transport or fail certain dissolution protocols. In one year, specialty requests have involved high-purity Norclobazam for custom solid-form development, and each time, putting in the extra drying steps and analytical tracking proved worthwhile. Specific surface area and particle size can appear trivial, but for direct tableting studies or comparative pharmacokinetic work, slight shifts affect compressibility and blending. We routinely field requests for custom sieving to accommodate such specific trial parameters.

    Norclobazam’s Niche and Role in Research

    Researchers turn to Norclobazam not only for its unique structure—a derivative of clobazam depleted at the N-2 position—but for its steady pharmacological profile and its role in forming new analogues. It falls squarely within the 1,5-benzodiazepine class, which yields a narrower side effect profile compared with its 1,4 relatives. In clinical settings and experimental synthesis, this difference often means fewer unwanted metabolites and more predictable biotransformations. From a production perspective, that translates to customers expecting tight batch-to-batch reproducibility, verified against internal reference standards. Over the years, recurring customers have reported that switching sources mid-research introduces risk, because not every supply chain maintains the same spec discipline. Beyond that, uncommon impurities can rise after extended storage if packaging doesn’t provide adequate protection from light and moisture. To address these, each pack leaves the plant doubly sealed, within inert atmosphere wherever feasible—lessons learned from earlier years, before new investments in moisture management equipment paid off.

    How Norclobazam Differs From Similar Compounds

    The transition from clobazam to Norclobazam changes more than just a substituent; it fundamentally shifts pharmacokinetics and binding affinity at GABA receptors. Years ago, our team compared the process chemistry of clobazam, Norclobazam, and several analogues. Small changes in reaction temperature or solvent choice led to large swings in yield, crystallinity, and impurity panel. With Norclobazam, the process leaves less latitude: the route requires tighter control and nearly immediate post-reaction cleanup, since its intermediates don’t tolerate long-standing. Current batches consistently meet qualified standards with minimal N-oxide formation and trace byproducts separated out before drying. Direct experience handling both APIs has demonstrated that Norclobazam stands less forgiving, and thus forces a rigorous adherence to purification steps like trituration, carbon treatment, and time-controlled drying. Customers with backgrounds working with clobazam typically note Norclobazam’s increased demands for careful storage and cautious handling—without which, even high-quality lots can degrade faster than anticipated.

    Building Trust in Quality Control

    Quality assurance doesn’t reduce to a checklist. Genuinely robust control relies on transparent standards, backed by analytical methods shared openly with clients. In our facility, each lot goes through full traceability, covering every step from receipt of base materials through intermediate formation, final synthesis, drying, and packing. Repeated validation against both in-house and external standards stops drift in measurement over time. Batch release isn’t triggered just after meeting minimum spec; it takes into account customer feedback on consistency, reported during use in actual research or downstream manufacturing. Sometimes a small tweak—like changing glassware or tweaking drying temperature—delivers a noticeable difference to users. We integrate those adjustments and update procedures, keeping analytical documentation accessible and reproducible. For Norclobazam, we find impurities most often show up as benzophenone derivatives or incomplete cyclization products. Routine use of techniques such as GC-MS and FTIR ensures these remain strictly under detection thresholds agreed upon with key buyers.

    Usage Patterns and Research Feedback

    Most researchers using Norclobazam target applications in CNS studies. In some cases, teams develop new pro-drugs, and others profile comparative transport properties through blood-brain barrier models. Very often, universities and biotech start-ups request smaller vials for initial SAR screening, expecting uncompromised quality, even in sub-gram scale. Larger, more established groups acquire kilogram lots for longer-term stability testing or formulation. Requests also come in for custom particle morphologies—needle-shaped, micronized, or low-dust forms. Real-world returns from global partners indicate that lot variability, even within tight margins, can impact repeatability of experiments, particularly for analytical reference work. To respond, we keep R&D and manufacturing teams talking, cross-referencing every outlier reported by customers with retained samples from the original lot. This closed feedback loop narrowed variability over the years and remains a major reason regular buyers stick with dedicated manufacturer supply.

    Environmental and Handling Considerations

    We all bear responsibility for sustainable practice in chemical manufacturing. Sourcing Norclobazam’s base materials places a premium on low-toxicity pathways and minimizing waste. Solvent recycling cut our plant’s hazardous liquid disposal footprint and reduced costs. Every stage from synthesis to drying, filtration, and packing happens in a closed system, with real-time monitoring. Experienced staff keep their eyes open for signs of decomposition—not just in raw material stockrooms but across blending and filling lines. Longstanding experience showed even a small slip, like storage near heat or leaving containers unsealed, makes Norclobazam degrade faster, resulting in yellowing or loss of potency. It’s why every outgoing batch comes with detailed storage instructions tied back to real experience, rather than generic warnings. Over the years, we’ve moved away from certain packaging materials that leach moisture, based on direct observation and client feedback. Such gradual improvements build trust, tighten quality, and encourage long-term relationships—not through flashy marketing, but via honest, visible results.

    Building Reliable Supply Chains—A Manufacturer’s Perspective

    Unbroken delivery matters more than press releases or shiny brochures. Customers depend on on-schedule shipments and transparency about lead times, especially when planning project timelines or regulatory filings. Disruptions in precursor supply sometimes happen, but close supplier relationships and holding buffer stocks keep orders flowing. Technician teams track key synthesis milestones in real time, sharing anticipated completion with commercial partners. That two-way transparency saves time and stress. On several occasions, a heads-up about an unforeseen raw material delay allowed customers to adjust plans with minimal fallout—a lesson that alternate sources rarely accommodate. Forward planning and regular communication tighten our resilience, and in practice, it’s the ability to adapt that wins long-term business, not just the certificate of analysis included in the box.

    Regulatory Experience and Documentation

    Any substance used in research or pre-commercial application typically attracts scrutiny from regulators, audit teams, and downstream pharmaceutical developers. To ease this process, our record-keeping covers every critical parameter—from reactor temperatures and hold times to batch-specific analytical readouts. Regulatory teams often demand more than a checkbox for certificate of analysis; they request in-depth data runs, long-term stability results, and supply chain provenance. Over the years, the practice of holding back archive samples for repeat testing, even years after original synthesis, kept compliance issues low. It isn’t about gold-plating documentation; it’s about showing real, reproducible, verifiable data in response to audits. Consistency and a culture of transparency help researchers and buyers cut through red tape, keep their own trials running, and avoid regulatory surprises. The routine willingness to share full documentation upfront has built relationships based on shared standards, rather than blind trust.

    Direct Customer Experience—Lessons from the Floor

    Where problems crop up, they rarely come from the textbook. Some labs found that Norclobazam, once exposed to high humidity, would pick up enough water to alter melting behavior or dissolve slower. To fix that, we introduced stricter controls, nitrogen-blanketed storage, and warned repeat users about prompt resealing. In a handful of cases, researchers flagged a faint odor or slight yellow cast in higher-aged samples. Following up on each report, we backtracked through process records, traced packaging faults, and found a link to certain packing films. Changing to a newer grade of HDPE minimized the problem and raised satisfaction for months. The best improvements come out of real issues faced by end users, not out of theoretical risk assessments. That’s why we place emphasis on practical fixes—swapping out problematic supplies, shifting to fresher packaging, and updating protocols based on what actually happens in partner labs. Close dialogue links manufacturing to real-world application and keeps both sides learning and improving.

    Emerging Developments and Future Directions

    The world of benzodiazepine research continues to evolve, often shifting focus in unexpected directions. In the last two years, demand for isotopically-labeled Norclobazam rose, particularly for metabolic tracing and pharmacokinetic profiling. We adapted by extending our synthesis routes, building up experience to deliver both unlabeled and labeled versions with reliable consistency. Customization requests keep coming, from demand for improved solubility to preference for dust-free formulations that make handling safer and more predictable in high-throughput environments. Ongoing feedback has spurred incremental tweaks—minimizing aggregation, tightening specifications on trace residual solvents, and testing new anti-caking agents compatible with pharma standards. Every new challenge brings lessons, feeding back into core process improvements.

    Why Manufacturer Experience Makes the Difference

    Spec sheets and certificates of analysis tell only part of the story. Day in, day out, smooth operation relies on people who know the quirks of benzodiazepine chemistry and who hear back from front-line researchers. Failures get spotted faster in-house, not years later in a remote QC audit. In today’s climate, with rising scrutiny on data integrity, the trust built from years of open feedback and real-world results matters more than short-lived price advantage. Responding quickly, shipping accurately, fixing problems rather than passing blame—these hallmarks shape real partnership. For Norclobazam, this culture has enabled long-term supply to research teams, formulation developers, and analytical reference labs globally. The proof stands not just in product shipped but in tests passed, projects finished, and customer stories shared. With each batch produced, the goal stays the same: proven reliability rooted in experience, learning, and openness with every professional who puts Norclobazam to work in their science.