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Butoconazole

    • Product Name Butoconazole
    • Alias Gynazole
    • Einecs 636-667-2
    • 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
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    Specifications

    HS Code

    488730

    Name Butoconazole
    Cas Number 64872-77-1
    Molecular Formula C19H17Cl3N2S
    Molecular Weight 427.78 g/mol
    Drug Class Antifungal (Imidazole derivative)
    Appearance White to off-white crystalline powder
    Route Of Administration Vaginal (topical)
    Mechanism Of Action Inhibits ergosterol synthesis by interfering with fungal cytochrome P450 enzymes
    Indications Treatment of vulvovaginal candidiasis
    Brand Name Gynazole-1
    Storage Conditions Store at room temperature, 20°C to 25°C (68°F to 77°F)
    Solubility Practically insoluble in water
    Half Life Approximately 22-29 hours (when administered vaginally)
    Atc Code G01AF15
    First Approval Year 1999

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

    Packing & Storage
    Packing The Butoconazole packaging features a white, sealed 25-gram plastic bottle labeled with chemical information, safety symbols, and manufacturer details.
    Shipping Butoconazole should be shipped in tightly sealed, clearly labeled containers, protected from light and moisture. Handle as hazardous material in accordance with local, national, and international regulations. During transit, it requires appropriate cushioning and temperature control, if specified, to prevent degradation or spills. Ensure documentation for chemical safety accompanies the shipment.
    Storage Butoconazole should be stored in a tightly sealed container, protected from light and moisture, at controlled room temperature (20°C to 25°C or 68°F to 77°F). Keep it away from incompatible substances, such as strong oxidizers, and store it in a cool, dry, and well-ventilated area. Ensure only authorized personnel handle and access the storage area.
    Application of Butoconazole

    Applications of Butoconazole in Industrial Manufacturing

    Butoconazole is a specialty active pharmaceutical ingredient (API) primarily used as an antifungal agent across select downstream sectors. As a direct manufacturer, we supply high-purity material for regulated industrial production purposes, adhering strictly to established compliance and processing standards. Below, we provide a breakdown of the principal real-world applications driving material consumption, each detailed by its unique industry protocols and operational framework.

    1. Pharmaceutical Formulation: Topical Antifungal Creams

    Leading pharmaceutical companies globally incorporate butoconazole as the main API for the manufacturing of vaginal and topical antifungal creams. Production lines require consistency in particle size distribution and purity for proper compounding into emulsion bases, ensuring even dispersion and target-level potency in final products. Formulators control excipients to stabilize butoconazole within oil-in-water or water-in-oil systems, maintaining product shelf life and bioavailability. Close control of raw material quality is critical for compliance with pharmacopoeial standards and to avoid API degradation during emulsification and filling.

    Industry compliance standards

    • U.S. FDA cGMP (21 CFR 210/211)
    • European Pharmacopoeia (Ph. Eur. monograph 2664)
    • United States Pharmacopoeia (USP)
    • ICH Q7 for API manufacturing

    Typical usage ratio

    • 2% w/w in cream base; adjustments depend on therapy requirements and regulatory approvals

    Downstream process integration

    • Direct addition into emulsion mixing tanks, typically during final cooling stage to prevent API degradation
    • Homogenization step to ensure even dispersion
    • In-line quality control for assay and microbial purity prior to packaging

    Final product types

    • Vaginal antifungal creams (Rx and OTC)
    • Topical fungal infection treatments

    2. Pharmaceutical Formulation: Suppositories and Ointments

    Butoconazole serves as a primary antifungal agent in the manufacture of solid and semi-solid dosage forms such as vaginal suppositories and ointments by specialist pharmaceutical manufacturers. Technologists select specific fat-based vehicles or gel-formers that optimize butoconazole release profiles and patient compliance. Stringent in-process controls during melting, API blending, and casting stages mitigate risks of uneven distribution and ensure dosing precision, in line with regulatory product monographs and stability requirements.

    Industry compliance standards

    • U.S. FDA guidelines for vaginal drug products
    • Good Manufacturing Practice (EU GMP Volume 4, Annex 1)
    • Japanese Pharmacopoeia for local registration
    • ICH Q1A(R2) Stability Testing Standards

    Typical usage ratio

    • 100 mg per suppository unit, corresponding to product-specific drug delivery profiles; adjusted for local regulatory filings

    Downstream process integration

    • Dissolution into lipid or gel matrices under controlled temperature
    • API addition post-melting to avoid decomposition
    • Continuous casting or filling into pre-sterilized molds or tubes

    Final product types

    • Vaginal suppositories for fungal infection treatment
    • Antifungal ointments for prescription market

    3. Contract Manufacturing of Generic APIs for Finished Dosage Export

    Licensed contract manufacturers synthesize and formulate butoconazole for bulk sale to global finished dosage producers. Operations require validated synthetic routes with strict impurity control strategies, batch record documentation, and intermediate testing to meet generic dossier requirements for regulated markets. Downstream customers rely on consistent physical characteristics of shipped material (particle size, polymorphic form), and manufacturers optimize recrystallization and micronization to support downstream tablet or cream formulation lines abroad.

    Industry compliance standards

    • WHO Prequalification Program
    • U.S. Drug Master File (DMF) submission requirements
    • EU CEP (Certificate of Suitability) for substance approval
    • China DMF system and GMP certification for export

    Typical usage ratio

    • 100% API shipment; packaged in drums aligned with customer formulation batch sizes (e.g., 1 kg, 25 kg, 50 kg)

    Downstream process integration

    • Bulk API transfer for downstream mixing, granulation, or milling
    • Material testing on receipt for identification, purity, and assay
    • Integration according to recipient’s product registration specification

    Final product types

    • B2B API for global formulation plants
    • Import stock for regulated generic and OTC antifungal products

    4. Research and Development Supply for Pharmaceutical Innovation

    Butoconazole is a standard antifungal benchmark for in vitro and preclinical studies conducted by pharmaceutical R&D divisions and academic laboratories. Clients procure GMP and non-GMP grade material to assess analog development, resistance profiles, and formulation innovations. Strict sample handing, analytical method validation, and small-batch synthesis for lead optimization studies characterize this segment, requiring rigorous lot traceability and documentation to support project auditing and future regulatory submissions.

    Industry compliance standards

    • OECD Good Laboratory Practices (GLP)
    • USP and EP reference standards for analytical methods
    • Research Use Only (RUO) labeling compliance
    • ISO 9001 for supply chain quality

    Typical usage ratio

    • Varies by protocol: typically 1–5 g per research trial, increasing to pilot batch scale for advanced studies

    Downstream process integration

    • Direct addition to test formulations, cell cultures, or animal model systems
    • Analytical reference for system suitability and equipment calibration
    • Batch control and archiving for result reproducibility

    Final product types

    • Reference standards for pharmaceutical research
    • Pilot-scale experimental formulations
    • Innovative antifungal lead candidates for pipeline development
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    Certification & Compliance
    More Introduction

    Introducing Butoconazole: Insight from a Chemical Manufacturer

    Butoconazole by the People Who Make It

    Ask anyone in a production team at a chemical manufacturer and you'll get the same answer: understanding a compound at its core comes from day-to-day handling, batch-to-batch analysis, and feedback from end-users. Butoconazole stands out in the azole family for its role in treating fungal infections, especially in pharmaceutical use as an antifungal active. We've spent years refining processes to deliver a Butoconazole product that offers high purity, batch consistency, and application reliability. These attributes don't happen by accident—they require continuous process control, starting with the selection of raw materials and extending through each synthesis and purification step.

    Our Butoconazole: Form, Purity, and Production Insights

    We produce Butoconazole in the form of a fine, off-white crystalline powder. Consistent particle size and appearance matter less to us than the chemical profile, but we maintain physical specs to support a smooth formulation experience for our pharmaceutical partners. Each lot receives full chromatographic analysis verifying purity usually exceeding 99%. Typical moisture and solvent residue levels fall well within pharmacopeia thresholds as we run sequential drying stages and maintain careful environmental controls in our dedicated antifungal lines.

    Manufacturing Butoconazole brings some unique challenges—not just in synthesis, where the creation of the azole ring system demands careful temperature and pH control, but also in the work-up, where trace byproducts can prove stubborn. Early on, we saw process variations affecting isomer ratios and establishing protocols to monitor for the relevant impurity profile has paid dividends. The result: a reproducible pharmaceutical ingredient that formulators have come to trust.

    Why End-Users Count on Consistency

    In an industry where a few tenths of a percent deviation can lead to trouble down the line—whether in tableting, quality control, or regulatory review—manufacturing consistency wins. With Butoconazole, product reliability stems from validated procedures under GMP, batch release according to strict SOPs, and data traceability back to every raw material drum. We’ve learned that even minor raw material source changes can cause headaches, so we lock in approved suppliers and screen all inputs for identity and contaminants.

    Processing Butoconazole has taught us that some solvents favor better yields but leave higher residue. Our response means thorough solvent removal steps, using temperature gradients rather than just vacuum, and confirming final product safety by running every batch through gas chromatography checks before lot release. The result isn't just a compliance box checked; it builds confidence throughout the supply chain, especially when regulatory submissions depend on sound data and predictable results.

    Intended Usage: Not Just an Ingredient, a Critical API

    Most of the Butoconazole we produce goes directly into finished dosage forms such as topical creams and suppositories. We’ve collaborated with partner pharma companies and contract manufacturers who report back to us on their mixing, extrusion, and packaging outcomes. Over time, this feedback loop informs our own process tweaks. For instance, we ensure free-flowing powder to avoid clumping in automatic feeders, which keeps high-speed production facilities running smoothly and reduces downtime.

    The device and method of application may differ—topical, vaginal—but the need for reliable, high-purity starting material never changes. The medical field demands actives that meet pharmacopeia standards and retain stability over transport and storage intervals. It doesn’t matter if we’re shipping locally or internationally; stability studies from our own test archive guide us in storing and moving Butoconazole in the right kind of sealed, light-blocking containers. Without this physical attention, the product would never pass muster in a real-world manufacturing setting.

    What Sets Butoconazole Apart from Other Azoles

    Chemists frequently compare Butoconazole to other azole antifungals—both for their molecular structures and spectrum of activity. Our team often hears requests to outline differences relative to clotrimazole, miconazole, or econazole. The side chain configuration and specific halogenation steps in Butoconazole’s synthesis yield a molecule with unique binding affinity and metabolic properties. In a practical sense, this means it remains active in certain topical applications where others lose efficacy or require reformulation. The presence of the chlorine atom differentiates its solubility profile and, more importantly from a manufacturing standpoint, demands specialized handling in the intermediate steps to mitigate potential safety risks.

    We handle cross-contamination concerns head-on by dedicating equipment solely to Butoconazole when running multi-product lines—cleaning validation and strict scheduling are part of our regular QA workflow. There's no shortcut for physical separation of active ingredients, especially with potent APIs. Our laboratory team tracks degradation patterns in long-term storage tests, which helps our partners determine product shelf life and optimal excipient compatibilities.

    Regulatory and Traceability Considerations

    The regulatory nature of active ingredients like Butoconazole calls for robust documentation. Retained samples from every batch enable us and our partners to address any future quality investigation. In the event of recalls or trending analyses, we can probe archived data to pinpoint any anomalies—something that doesn’t happen without tight manufacturing and record-keeping discipline.

    We’ve witnessed rising expectations from global regulators for transparent batch genealogy, starting from the initial charge of raw materials right through to final drying and packaging. Serialization, though labor-intensive at times, prevents mix-ups and ensures our customers get exactly what the paperwork says. When audits from agencies or client companies happen, we open the books and the facility—every SOP, every deviation report, every cleaning record. That’s the level of scrutiny a manufacturer faces, especially with an API intended for health applications.

    Market Trends and End-Use Shifts

    Demand for Butoconazole doesn’t remain static; it follows health trends and prescription preferences. As resistance patterns shift and physicians turn to older or newer antifungals based on clinical efficacy, our production volumes swing accordingly. We keep close tabs on order trends and regional regulatory changes. Occasionally, a new generic approval or a change in treatment guidelines fast-tracks an increase in inquiries, and our inventory planning must stay agile to avoid bottlenecks or overstock risks.

    We stay close to our pharma partners not out of courtesy but necessity. If an end-user faces a supply disruption or product launch, we coordinate on accelerated lots, customized packaging, or documentation support—our manufacturing flexibility becomes their competitive advantage. Product recalls or shortages elsewhere in the supply chain usually bring us urgent rush orders, making traceability and on-hand inventory vital. Extended lead times for key intermediates in Butoconazole synthesis push us to invest in local sourcing relationships or forward-buying contracts.

    Operational Insights: From R&D Bench to Commercial Scale

    The original synthesis of Butoconazole in our pilot lab involved careful balancing—yield vs purity, cost vs waste, scalability vs environmental impact. Most lab procedures work well on a gram scale, but moving to commercial reactors introduces new variables: mixing efficiency, equipment fouling, reaction exotherms, and waste disposal. The transition from R&D to full-scale production required iterative adaptation—sometimes rethinking solvent selections or crystallization steps to meet quality targets at scale.

    Troubleshooting at the plant level isn’t theoretical. An impurity spike or an off-odor during drying points to a process glitch. We don’t sweep such findings under the rug; instead, we document deviations, investigate root causes, and implement changes. Some tweaks become permanent process changes, and every operator gets trained on updated instructions. In this way, production history builds resilience, and our customers reap the benefits through stable, high-quality Butoconazole.

    Sustainability, Safety, and Environmental Impact

    Sustainability concerns aren’t just for public relations—they show up in environmental audits and ongoing compliance. Butoconazole synthesis produces specialty organic waste that needs specialized disposal. We established separation tanks and onsite pre-treatment, reducing the hazard profile before licensed waste handlers complete disposal. Regular air and water monitoring keeps us inside emission limits, and continuous improvement projects aim to further reduce solvent and water use per kilogram of output.

    Operator safety comes first. The raw materials and some intermediates in Butoconazole synthesis require well-defined handling protocols—personal protective gear, monitored storage for volatile components, and closed systems that minimize spillage or airborne exposure. Training sessions happen regularly, and incident drills remain a staple. We share safety best practices at industry roundtables because a safer sector benefits everyone, not just our company.

    Challenges in the Global Supply Chain

    Raw material pricing swings can pinch profit margins on Butoconazole. Market newcomers offering cheaper but inconsistent compounds tempt some buyers, yet we’ve seen too many short-lived cost savings morph into major headaches—failed batches, delayed releases, or even regulatory rejections. We learned over decades that controlling upstream relationships and maintaining audited supply partners always trumps a low quote from an unfamiliar broker.

    Trade policy changes, transportation slowdowns, and currency fluctuations can disrupt timelines. Our logistics team works just as hard as production, coordinating temperature-controlled storage, customs documentation, and contingency plans for unexpected events. During the recent pandemic, we experienced firsthand the cascading effects of border shutdowns and supply route reallocations. Stockpiling key intermediates and maintaining multiple shipping lanes proved critical to keeping our customers in stock and avoiding person-to-person supply interruptions.

    End-User Collaboration and Ongoing Innovation

    We don’t exist in isolation. Pharmaceutical partners, raw material suppliers, and end-users all influence our approach to Butoconazole production. Years of collaboration with formulators brought improvements in powder flow, bulk density, and even particle morphology based on feedback from high-throughput filling lines. Some innovations came out of necessity—like developing a low-dust version for environments where airborne particulates trigger sensitivity alarms or labor disputes.

    Our technical team regularly fields questions on solubility and compounding approaches. We see how a seemingly simple formulation tweak—like switching an excipient or adjusting water content—impacts finished product stability, bioavailability, or patient acceptance. Sharing these findings in technical roundtables helps raise the bar across our client base.

    Quality isn’t just a buzzword for us; each kilogram of Butoconazole sold ties directly to our reputation. Any negative feedback drives improvement cycles. Most issues resolve by working directly with the customer, reviewing batch records, and tracing each production variable. Sometimes a seemingly minor issue brings about a significant leap forward, whether in formulation robustness, packaging choices, or even secondary impurity controls.

    Looking Ahead: What Future Manufacturing Brings

    The future of Butoconazole manufacturing ties directly to advances in process automation, analytical chemistry, and global regulation. New continuous processing technologies offer opportunities for real-time monitoring and more efficient resource use. Analytical tools—like online NMR or advanced mass spectrometry—let our teams make immediate process decisions that benefit product consistency. As regulatory standards rise, so do our internal benchmarks. Real-world product use and patient health outcomes motivate ongoing vigilance.

    End-users can expect further refinements as newer application forms and combination products hit the market. We anticipate more demand for tailored particle size options, tighter impurity thresholds, and transparent carbon footprint disclosures for major pharmaceutical manufacturers. The journey isn’t over; every batch we make leads to a new insight, a new collaboration, or a new production record worth surpassing. Our experience manufacturing Butoconazole drives us to keep raising the bar, both for ourselves and our global partners relying on a trusted supply.

    Conclusion: Why Manufacturer Perspective Matters

    As a chemical manufacturer, our perspective on Butoconazole is shaped by years at the bench and on the shop floor. It’s not a theoretical commitment to quality—it’s lived daily, driven by customer needs, global trends, safety demands, and a constant push for innovation. Butoconazole matters not just because of its clinical role but because of the trust placed in our manufacturing to deliver a product that performs every time. Each lot reflects the collective experience of chemists, plant operators, analysts, and logisticians whose work ensures that end-users receive a product worth their confidence.