Amoxicillin and Clavulanate Potassium

    • Product Name: Amoxicillin and Clavulanate Potassium
    • Chemical Name (IUPAC): (2S,5R,6R)-6-[(2R)-2-amino-2-(4-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid and potassium (2R,3Z,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate
    • CAS No.: 26787-78-0
    • Chemical Formula: C16H19N3O5S·C8H8KNO5
    • Form/Physical State: Solid
    • Factroy Site: No. 777, Shengli West Road, Yuhui District, Bengbu City, Anhui Province, China
    • Price Inquiry: sales3@ascent-chem.com
    • Manufacturer: Anhui BBCA Group Co., Ltd
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    Specifications

    HS Code

    462477

    Generic Name Amoxicillin and Clavulanate Potassium
    Brand Names Augmentin, Augmentin XR
    Drug Class Penicillin-type antibiotic (beta-lactam antibiotic and beta-lactamase inhibitor)
    Route Of Administration Oral
    Dosage Forms Tablets, chewable tablets, oral suspension
    Indications Bacterial infections (e.g., respiratory tract infections, urinary tract infections, skin infections, sinusitis, otitis media)
    Mechanism Of Action Inhibits bacterial cell wall synthesis and inhibits beta-lactamase enzyme
    Pregnancy Category B
    Rx Otc Status Prescription only
    Common Side Effects Diarrhea, nausea, vomiting, skin rash, allergic reactions
    Storage Conditions Store at 20° to 25°C (68° to 77°F), protect from moisture
    Contraindications History of allergic reactions to penicillins or cephalosporins

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

    Application of Amoxicillin and Clavulanate Potassium

    Purity 98%: Amoxicillin and Clavulanate Potassium with a purity of 98% is used in acute bacterial sinusitis treatment, where it ensures rapid reduction of bacterial load and symptom resolution.

    Molecular Weight 419.46 g/mol: Amoxicillin and Clavulanate Potassium with molecular weight 419.46 g/mol is used in lower respiratory tract infection therapy, where consistent dosing accuracy enhances clinical efficacy.

    Solubility 30 mg/mL: Amoxicillin and Clavulanate Potassium with solubility of 30 mg/mL is used in intravenous formulations for severe skin infections, where high solubility supports fast systemic delivery.

    Stability Temperature 25°C: Amoxicillin and Clavulanate Potassium with stability temperature at 25°C is used in pharmacy shelf storage, where it maintains antimicrobial potency during standard storage conditions.

    Particle Size D90 <10 µm: Amoxicillin and Clavulanate Potassium with a particle size D90 below 10 µm is used in oral pediatric suspensions, where fine particle size allows uniform suspension and precise dosing.

    pH in Solution 6.5: Amoxicillin and Clavulanate Potassium at pH 6.5 in solution is used in gastrointestinal infection therapies, where optimal pH reduces gastrointestinal irritation and enhances patient compliance.

    Bulk Density 0.55 g/cm³: Amoxicillin and Clavulanate Potassium with bulk density 0.55 g/cm³ is used in solid tablet manufacturing, where controlled density supports uniform tablet compression.

    Moisture Content <1.5%: Amoxicillin and Clavulanate Potassium with moisture content below 1.5% is used in long-term storage applications, where low moisture content prevents degradation and prolongs shelf life.

    Packing & Storage
    Packing The packaging is a white and orange box containing 20 tablets of Amoxicillin and Clavulanate Potassium, clearly labeled with dosage details.
    Container Loading (20′ FCL) 20′ FCL loaded with securely packed containers of Amoxicillin and Clavulanate Potassium, ensuring safe, compliant shipment for bulk pharmaceutical supply.
    Shipping Amoxicillin and Clavulanate Potassium should be shipped in tightly sealed containers, protected from light and moisture. Maintain the recommended temperature, usually below 25°C (77°F), and avoid freezing. Compliance with all regulatory labeling and documentation is required, ensuring safe and secure transit according to pharmaceutical transport standards.
    Storage Amoxicillin and Clavulanate Potassium should be stored in a tightly closed container at 20°C to 25°C (68°F to 77°F), protected from moisture, heat, and light. If it is supplied as a suspension, refrigerate at 2°C to 8°C (36°F to 46°F) and discard any unused portion after 10 days. Keep out of reach of children.
    Shelf Life Amoxicillin and Clavulanate Potassium typically has a shelf life of 2 years when stored in a cool, dry place, unopened.
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    More Introduction

    Amoxicillin and Clavulanate Potassium: Direct From the Manufacturer

    Our Approach in Antibiotic Production

    After years of manufacturing antibiotics, we understand that life depends not only on breakthrough science, but on reliability in day-to-day practice. Amoxicillin and Clavulanate Potassium reflect this principle. We’ve developed and produced this compound in bulk, scaled precisely for the needs of hospitals, clinics, and pharmaceutical producers facing resistant bacteria in real patients, not just controlled lab conditions.

    Inside the Product: Composition and Proven Strength

    Amoxicillin, a time-tested beta-lactam antibiotic, continues to serve as a cornerstone for many treatment protocols. By combining it with clavulanate potassium, a potent beta-lactamase inhibitor, we force open a wider door where bacteria once blocked the path. Through local and global supply projects, we've seen this blend provide consistent results in the fight against both common and emerging pathogens.

    We produce this combination in several forms: pure active pharmaceutical ingredients (API) for downstream formulation, finished powder for reconstitution, and coated granules for tablet manufacturing. Each lot undergoes rigorous quality control against pharmacopoeial standards, from physical properties down to contaminant thresholds. Particle size, moisture levels, and chemical purity follow strict protocols—those checks don’t leave room for shortcuts.

    Clinical Use: Meeting Doctors’ Demands

    Doctors tell us stories every year—about children who bounce back from pneumonia, about patients with diabetic foot infections whose wounds start closing after starting the right drug, about the challenge of treating UTIs resistant to older antibiotics. These stories reinforce what the data already say: Amoxicillin and clavulanate, paired together, push back against many forms of beta-lactamase-producing bacteria that resist simple amoxicillin alone.

    Blends containing 2:1 and 4:1 amoxicillin-to-clavulanate ratios anchor oral and IV formulations. For oral suspension, we keep particle suspension properties tight to avoid settling, which helps keep doses consistent for each patient. Our direct manufacturing control lets us guarantee uniformity from the very first bottle to the last.

    Years ago some hospitals told us that older, single-agent beta-lactams lost effectiveness against resistant E. coli and Klebsiella. Our technical team worked alongside infectious disease doctors, delivering higher-yield batches of the combined formula. Today, many regions see far fewer failed first-line treatments thanks to this combination. That's not marketing—those are numbers we see in procurement reports and direct feedback from large clinics.

    Contrasting With Other Antibiotics and Generics

    The global market overflows with generic antibiotics. What we've heard from purchasing managers goes beyond just cost: consistency, stability under transport, and reliable shelf-life matter in real-world scenarios, not just in theory. Many generics lose potency if mishandled. Loose control over active ratios or excipient blends in generics can lower a drug’s impact, especially after long shipping times or storage in humid climates.

    By producing in-house, we trace every lot of Amoxicillin and Clavulanate Potassium to source materials and batch records. No third-party or broker shuffles product between mysterious warehouses. Full vertical integration reduces cross-contamination risk, and lets us act quickly when regulators require updates or changes. That’s a responsibility that reaches beyond compliance—it’s about knowing that someone’s grandmother, someone’s child is trusting this antibiotic to do its job.

    Many ask us: why not just use standalone amoxicillin, especially in mild cases? Bacterial resistance tells the story. Beta-lactamase enzymes, which many strains produce today, neutralize amoxicillin’s effect. Adding clavulanate blocks those enzymes, re-opening paths for successful treatment. Instead of cycling through several drugs and risking broader resistance, starting with this combination often means better outcomes with fewer complications and side effects.

    Cephalosporins, penems, and fluoroquinolones fill other medical gaps, but carry greater risk for C. difficile or promote even more resistance if overused. By keeping our production lines focused on dual-component amoxicillin and clavulanate, we aim for a sweet spot—high utility, sensible stewardship, and reduced selection pressure for secondary resistance.

    Stability and Safety: Real-World Storage and Transport

    From our warehouses to customer sites, stability stands as more than a technical detail. In Southeast Asian climates, uncoated granules from some suppliers broke down in weeks and lost clinical power. Our thermally stable packaging, plus ongoing investment in microsealing and vacuum batching, lets us maintain shelf-life and potency under demanding conditions.

    Accidental substitutions or mix-ups between amoxicillin, ampicillin, or unclear imports have led to adverse clinical incidents—an issue that’s kept us vigilant. Every API lot and finished batch leaves our plant with traceable, tamper-evident labeling. We produce batch certificates based on in-house and third-party QC to safeguard against cross-product confusion.

    During the peak of the COVID-19 pandemic, transport bottlenecks and customs delays threatened to interrupt antibiotic supply. By holding larger reserve stocks and monitoring real-time inventory, we helped keep hospitals supplied even when sea freight slowed or airports shut down. That period made clear to us that strong manufacturer-to-client connections count for as much as technical competence.

    Antibiotic Stewardship and Regulatory Confidence

    Every manufacturer faces regulatory discipline. We see this not as an external burden, but as an internal priority. Each country sets defined permissible levels of impurities, limits for heavy metals, and expectations for analytical testing. Our regulatory staff engage directly with both local ministries and international agencies. Keeping full documentation, method validation reports, and post-market surveillance feedback ready protects everyone downstream.

    Beyond paperwork, practical stewardship matters. Overuse of broad-spectrum drugs has created regional “hot zones” of resistance. We work with purchasing bodies and major health systems to set rational order cycles. In some years, we recommend staggered purchases or dilution of certain lots to help prevent stockpiling beyond expiration. This isn't just business; it's about supporting healthier, more sustainable antibiotic use patterns.

    Many generic resellers cannot support these stewardship goals. Their supply lines start and stop outside the plant gates, often without end-to-end product knowledge or back-end records that will stand up in a regulatory audit. If a hospital reports a suspected substandard batch, only a manufacturer with full process control and an unbroken batch record can respond with meaningful corrective action.

    Practical Benefits to Users and Healthcare Providers

    Feedback from our long-term buyers shapes how we produce. Larger hospitals who once lost hours managing muddy suspensions now request our easy-to-mix oral grains, which reduce errors and waste. For clinics in remote regions, we use secondary packaging designed to resist humidity and insect damage during transport, ensuring medicine arrives as potent as it leaves our doorstep.

    Some hospital pharmacists have praised our custom batch arrangements. After feedback about smaller dose requirements for pediatric use, we developed micro-granule forms with precisely adjusted amoxicillin-to-clavulanate ratios. Simple conveniences like faster suspension times or reduced sedimentation rates may sound minor, but lead to better patient adherence and lower accidental misdosing—details that can shift patient outcomes decisively.

    On the compounding side, bulk buyers appreciate that our APIs disperse cleanly into standard excipients with little need for additional mixing time. This saves labor, cuts costs, and lets compounding pharmacies turn orders around more quickly. Whether for direct dispensing as finished tablets, or local reconstitution into suspension, our product’s physical stability stands up under the hands-on scrutiny of experienced pharmacists.

    Environmental Impact and Waste Management

    Antibiotic production, left unchecked, risks harming the environments and communities around us. We’ve invested in closed-cycle solvent reclamation and have modernized effluent treatment as part of plant upgrades spurred by rising waste standards in the past decade. Not only do these steps follow local regulations, they preserve relationships of trust with our surrounding community—our neighbors, workers’ families, and local farmers who depend on clean water and air.

    By tightly controlling waste and emissions, and tracking every precursor and finished batch, we contribute to larger global efforts to slow antimicrobial resistance. Poorly made bulk antibiotics may leach into soil or water, creating low-level exposure that triggers resistance spread. We engineer our processes to minimize residue, batch rejection, and chemical spillage. Safe manufacturing isn't optional—it’s part of our DNA.

    A few years ago, we opened our doors to third-party environmental audits; we continue annual reviews, using feedback to further reduce any environmental footprint. Responsible stewardship of both medicine and the planet is not just compatible—it’s inseparable in our line of work.

    Future Development and Collaboration

    New pathogens arise and old ones evolve. We maintain direct partnerships with global research teams, universities, and medical NGOs to monitor emerging beta-lactamase variants and shifts in resistance patterns. Based on these data, our R&D division refines production parameters, adjusts ratios, and prepares for rapid scale-up of next-generation β-lactamase inhibitors.

    Continuous dialogue with clinical partners drives practical innovation. If a trial reports new interactions or side effects, we rapidly convene our scientific and production experts to evaluate options and, if needed, adapt formulation or production scales. By owning every step from the reaction vessel to packaging, we offer both flexibility and fast problem-solving—assets that matter for public health and trust.

    Reliable Supply for an Uncertain World

    Surges in disease outbreaks, disruptions in trade, and unexpected spikes in demand regularly test medicine supply chains. We learned hard lessons managing the supply during the West African Ebola crisis, and during cyclone-induced disasters in southeast Asia. In each instance, resilient supply depends on scalable production, careful inventory planning, and the ability to track and reroute shipments without red tape.

    Trusted distribution means more than filling orders: field reports from disaster sites reached us even when global media missed them, letting us anticipate secondary surges and arrange emergency shipping in time to prevent shortfalls. Hospitals seeking steady, predictable access to amoxicillin and clavulanate benefit from our experience managing both slow and crisis modes.

    No distributor or short-term bulk trader understands a batch’s origin, composition, and transport lifespan like the manufacturer producing and packing every gram. Our decades in the field mean fewer recalls, lower spoilage rates, and unwavering supply—even during price shocks or logistics bottlenecks.

    Why Direct Manufacturing Matters

    Years spent producing this combination have taught us that shortcuts come with risks: loss of potency, degradation in transport, inconsistent output, and uncertainty in traceability. Hospitals and drug producers investing in direct-sourced Amoxicillin and Clavulanate Potassium purchase not just active ingredients, but the sum total of hard-won expertise, process control, and accountability that only comes from deep manufacturer involvement.

    Each customer, from leading city clinics to rural health networks, deserves medicines that work from the first dose to the last. We produce this antibiotic to deliver on that promise—meeting not only the standards set by regulators, but the expectations of medical professionals and patients counting on effective treatment today and into the future.