|
HS Code |
463701 |
| Generic Name | Cefazolin Sodium |
| Drug Class | First-generation cephalosporin antibiotic |
| Formula | C14H13N8NaO4S3 |
| Molecular Weight | 476.5 g/mol |
| Administration Route | Intravenous or intramuscular |
| Indications | Bacterial infections, surgical prophylaxis |
| Mechanism Of Action | Inhibits bacterial cell wall synthesis |
| Common Dosage | 250 mg to 2 g every 8 hours |
| Half Life | 1.8 hours |
| Contraindications | Hypersensitivity to cephalosporins |
As an accredited Cefazolin Sodium factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
|
Purity 99%: Cefazolin Sodium with purity 99% is used in surgical infection prophylaxis, where high purity ensures minimized risk of contamination and reliable antimicrobial efficacy. Particle size <50 µm: Cefazolin Sodium with particle size <50 µm is used in intravenous formulations, where fine particles provide rapid dissolution and consistent bioavailability. Stability at 25°C: Cefazolin Sodium with stability at 25°C is used in hospital pharmacy storage, where maintained stability ensures extended shelf life and preserved activity. Aqueous solubility ≥50 mg/mL: Cefazolin Sodium with aqueous solubility ≥50 mg/mL is used in injectable preparations, where superior solubility enables accurate dosing and fast therapeutic onset. Endotoxin level <0.25 EU/mg: Cefazolin Sodium with endotoxin level <0.25 EU/mg is used in critical care antibiotics, where low endotoxin contamination reduces the risk of inflammatory responses in patients. pH 4.5–6.0: Cefazolin Sodium with pH 4.5–6.0 is used in parenteral administration, where optimal pH ensures compatibility with physiological fluids and reduces irritation at the injection site. Residual solvent <0.1%: Cefazolin Sodium with residual solvent <0.1% is used in pharmaceutical manufacturing, where low residuals ensure compliance with safety standards and high purity of final products. Sterility certified: Cefazolin Sodium with sterility certified is used in compounding sterile preparations, where certified sterility assures patient safety and prevents secondary infections. Low moisture content <2%: Cefazolin Sodium with low moisture content <2% is used in powder formulation for reconstitution, where reduced moisture content enhances product stability and reduces degradation risk. Assay ≥98%: Cefazolin Sodium with assay ≥98% is used in cephalosporin antimicrobial therapy, where high assay guarantees therapeutic potency and consistent clinical outcomes. |
| Packing | Cefazolin Sodium packaging: Sterile, clear glass vial containing 1g powder, sealed with a rubber stopper and aluminum cap, labeled with dosage details. |
| Container Loading (20′ FCL) | Container Loading (20′ FCL) for Cefazolin Sodium typically includes 8MT (drums) or 14MT (boxes), ensuring secure, moisture-resistant packaging. |
| Shipping | Cefazolin Sodium should be shipped in tightly sealed, clearly labeled containers, protected from light and moisture. It requires storage at controlled room temperature (20–25°C) and should be transported in compliance with relevant regulations for pharmaceuticals, ensuring the integrity and safety of the product during transit. Avoid excessive heat and freezing. |
| Storage | Cefazolin Sodium should be stored at controlled room temperature, typically between 20°C to 25°C (68°F to 77°F). Protect it from light and moisture. Once reconstituted or diluted, use the solution promptly or store under refrigeration between 2°C to 8°C (36°F to 46°F) and discard if not used within the recommended time frame. Always follow specific manufacturer guidelines. |
| Shelf Life | Cefazolin Sodium has a typical shelf life of 2 to 3 years when stored in a cool, dry place, away from light. |
Competitive Cefazolin Sodium prices that fit your budget—flexible terms and customized quotes for every order.
For samples, pricing, or more information, please contact us at +8615365186327 or mail to sales3@ascent-chem.com.
We will respond to you as soon as possible.
Tel: +8615365186327
Email: sales3@ascent-chem.com
Flexible payment, competitive price, premium service - Inquire now!
As a manufacturer with decades spent watching the evolution of APIs and antibiotics, I’ve seen trends come and go. Cefazolin Sodium stands out as more than just a generic entry on a product list. Healthcare providers across clinics and hospitals depend on it as a first-line cephalosporin. For us, every lot rolling off our reactors is the result of precise controls, experience, and a responsibility that never gets old. Cefazolin Sodium is manufactured, not traded, here — hands-on chemistry and an unwavering focus on process control keep its quality consistent dose after dose.
Unlike newer molecules that sometimes promise a broader coverage, Cefazolin Sodium fills a particularly important need thanks to its time-tested safety record and focused activity against common skin, bone, and soft tissue pathogens. It’s one of the oldest cephalosporins still widely used for surgical prophylaxis and treating moderate infections where Gram-positive cocci, particularly Staphylococcus aureus, remain a concern. The sodium salt allows for ready dissolvability in sterile water, making it suitable for intravenous or intramuscular injection — a detail that matters on the ward and in the operating room, where hydration, solubility, and reconstitution time can impact clinical workflow.
Scaling up Cefazolin Sodium production involves more than simply following a formula. We source high-purity raw materials and keep each lot traceable through the entire chain. Starting from 7-ACA (7-aminocephalosporanic acid), the molecule’s cephalosporin nucleus, our chemists enforce strict reaction conditions—exact temperatures, pH, and order of addition—with every batch monitored for contaminants by validated analytical methods.
After the acylation and isolation steps, we convert the free acid to the sodium salt through carefully controlled neutralization. This stage demands not just technical proficiency but vigilance, because incomplete reaction or residual impurities could compromise stability or patient safety. Every shift operator here learns to read the details: crystal clarity, granule density, batch-to-batch color, flowability in the dryer. These are cues that a skilled chemist notices—signs of a process running right, or wrong.
Our finished Cefazolin Sodium powder is sterile filtered and freeze-dried, offering healthcare professionals unmatched stability on their shelves. Specified moisture content ranges between 2.5% and 4.0%. Endotoxin levels, particulate matter, and residual solvents are measured against pharmacopeial standards, not just for compliance, but to put our reputation on the line with each shipment. This is how we earn and keep the trust of hospital pharmacists, procurement officers, and doctors who rely on product quality that doesn’t cut corners.
Each lot is dosed to ensure at least 98.5% assay content by HPLC. Subvisible particles receive just as much attention as sterility—any sign of agglomeration means a full investigation and often process adjustment. Color and texture aren't simply cosmetic for injectable drugs: off-color samples mean possible oxidative degradation, which translates into real risks for end-users.
Since stability is central, we store and ship every order under controlled conditions, employing real-time temperature monitoring. Cefazolin Sodium absorbs moisture easily, so every pack — typically 1 g and 0.5 g vials for clinical settings — uses pharmaceutical glass and pharmaceutical-grade stoppers to maintain sterility and potency for the full shelf life.
Many in the industry still think of antibiotics as commodity items with little to distinguish one batch from another. Our production line has been set up to offer several model variants based on regional pharmacopeia requirements: USP, EP, and JP. Each variant responds to differences in impurity profiles set by these pharmacopeias. Sometimes it’s not enough to meet the minimum. By recertifying our production against shifting regulatory targets, we ensure supply isn’t interrupted when guidelines change.
Traceability defines our operation. Batch records are stored for years, and we make Certificates of Analysis available on request, as well as Certificates of Suitability for international customers. This transparency builds real-world confidence — not with vague assurances, but through specifics that regulators and buyers can trace from finished product back to raw material origin.
Cefazolin Sodium’s most frequent use is for perioperative prophylaxis. One dose administered just before incision significantly reduces the risk of surgical site infections. Without it, the rates of post-surgical infection—especially following orthopedic and cardiovascular operations—would rise, resulting in extended hospital stays and increased healthcare costs. Surgeons value rapid absorption and consistent pharmacokinetic profiles, relying on each dose to deliver predictable tissue levels.
Physicians on the floor use Cefazolin Sodium for empiric treatment of skin and soft tissue infections, uncomplicated urinary tract infections, and certain bone infections. Because it targets penicillinase-producing staphylococci, it remains a key agent for methicillin-susceptible Staph aureus (MSSA) infections, even as MRSA prevalence grows. Our commitment to zone diameter and minimum inhibitory concentration (MIC) consistency ensures that isolated strains fall within proven, published clinical breakpoints.
Compared with newer extended-spectrum cephalosporins—or broad-spectrum carbapenems—Cefazolin Sodium plays a more focused role. The molecule has limited activity against Gram-negative and anaerobic bacteria, keeping selection pressure lower on unrelated flora. This focused spectrum limits disruption of the gut microbiome and supports antimicrobial stewardship in acute care. Overuse of broad-spectrum agents breeds resistance; Cefazolin Sodium remains effective where targeted therapy is appropriate, enabled by years of careful use.
Generic competition in antibiotics typically narrows to price. We push back against reducing drug selection to dollars per vial by focusing on robust manufacture, purity, and reliable supply. Cefazolin Sodium sets itself apart from alternatives on a few clinically significant points.
Compared to first-generation oral cephalosporins, injectable Cefazolin Sodium achieves higher and more rapid serum and tissue levels. Surgeons prefer it for preoperative prophylaxis because oral drugs do not offer the same coverage or the assuredness of compliance.
Amoxicillin or clindamycin, sometimes prescribed for similar indications, come with different risks: allergic cross-reactivity profiles and possible Clostridium difficile overgrowth, respectively. Cefazolin Sodium presents a lower risk of gastrointestinal disturbance. It demonstrates rare cross-allergenicity with penicillins — a key consideration for hospitals managing post-surgical pain or allergies.
In the context of MRSA prevalence, vancomycin remains an alternative. Yet for patients with confirmed or suspected MSSA infections, Cefazolin Sodium is less nephrotoxic, has a superior safety margin, and matches or exceeds vancomycin for clinical outcomes in appropriately selected cases. A recent meta-analysis published in "Clinical Infectious Diseases" showed that using Cefazolin for MSSA led to lower mortality and reduced rates of nephrotoxicity compared to vancomycin, supporting its preferred status in these scenarios.
Manufacturers play a direct role in fighting antimicrobial resistance. By producing high-purity, unadulterated Cefazolin Sodium, we prevent sub-therapeutic dosing — a key driver of resistance. Lower quality lots, common with some discount suppliers, not only jeopardize patient outcomes but quietly seed local reservoirs of resistant organisms.
We monitor published resistance trends, implement changes in cleaning protocols, and rigorously remove potential antibiotic residues from equipment between batches. That’s not only for patient safety, but also to make sure cross-contamination can never set up a scenario where resistance emerges due to the manufacturing process itself.
By producing to scale without sacrificing specification, we support national and global stewardship programs. We only supply for indications approved by guidelines and work closely with hospital partners to prevent misuse or stockpiling, which can also drive resistance.
As a manufacturer with direct responsibility for everything from kilo-scale fermentation to freeze-dried vials, we recognize how fragile pharmaceutical supply chains can become. A single shipment delay, local raw material shortage, or customs hold can ripple across clinic shelves within days.
We build our inventory based on real demand signals from hospital consortia and direct contracts, avoiding speculative overproduction. By controlling storage environments and rotating stock, we prevent expired lots from entering any channel. Unlike brokers or traders, we neither cut batches to match orders nor stretch product beyond validated shelf life. Every dose coming out of our warehouse reflects the same stability-tested conditions as our internal reference samples.
Direct relationships with raw material vendors, frequent in-house audits, and emergency backup plans for power and refrigeration help us give hospital buyers peace of mind that Cefazolin Sodium will be available when patients need it, no matter what’s happening in the broader market.
Not every supplier is equal, a lesson many hospitals learn too late. As a manufacturer, we welcome — even encourage — third-party testing. Many clients ask for independent lab validation of our lots, and we support this by providing split reference samples and attesting to method details so tests match. We retain reserve samples from each batch for up to five years, ready for retesting if questions arise down the road.
We publish quality data in technical bulletins, reporting not just successes but also non-conformance findings and their root causes. This openness builds a feedback loop between ourselves and clinical partners, improving processes and aligning with E-E-A-T principles by showing not just what we claim, but what we actually deliver.
Some new drugs get the attention. The clinical teams in real hospitals rely on antibiotics that perform as expected with every lot. Cefazolin Sodium keeps its spot on hospital formularies because of a safety record built over fifty years, a narrow but reliable spectrum, and consistent results. Our role is to make sure that every lot meets the same high standard — not just the first time, but every time.
We’ve engineered redundant in-process tests, never relying solely on release checks. UV spectra are compared, not just to compendial standards but to internal benchmarks developed over years. Microbial challenge studies aren't just checked at validation — several lots a year are stress-tested, confirming stability under stressed storage. These details, invisible to the end user, make all the difference between a product hospitals trust and one they hesitate to use beyond a pinch.
Waste stream compliance grows more important with tighter local and international regulations. Our reactors are modified to recover solvents, reduce effluent contamination, and capture antibiotic residues before discharge. Pergens and caustics are neutralized through in-line systems, regularly checked by outside labs. This isn’t just about environmental risk, but about being welcome in communities where we operate — building trust not only with customers but also with neighbors.
Our approach to sustainable production isn’t a side project. Energy use and carbon footprint audits lead directly to new equipment investments, and periods of process downtime are scheduled to maximize waste treatment efficiency. Though these investments impact near-term margins, they reflect a long-term vision for antibiotic manufacturing that doesn’t cut corners for quick gain.
Cefazolin Sodium’s physical characteristics — a fine, off-white to yellowish powder — require specialized attention. Hygroscopic powders clump with even moderate moisture ingress. Each glass vial is nitrogen-flushed and double sealed to prevent contamination in transit. Labels contain not just batch and expiration data but full traceability for returns or recalls. Lot number scanning ties back directly to our manufacturing database, expediting investigations for any out-of-spec sample, and these measures support clients who must maintain rigid accountability for controlled substances.
In hospital pharmacies, staff can reconstitute our Cefazolin Sodium in as little as two minutes, with clear dissolution and no visible particulates. These tactile, observable qualities reflect our focus on producing an injectable that anticipates the needs of frontline healthcare staff — not just passing a specification, but excelling at the details that smooth everyday clinical work.
Every new employee on our line receives on-the-job mentorship by technicians who have watched hundreds of batches progress from raw material to finished vial. We run annual blind audits, challenge our own processes, and ask clients to provide direct feedback on every order. Only this level of direct engagement keeps standards rising while error and drift are caught early.
We make our process documentation robust but understandable. Hospital buyers and regulatory bodies don’t want marketing claims; they want proof. We share our in-house audit findings, inspection logs, and product improvement notes freely — this approach has earned us repeat business and complaints that lead to real change, not just excuses.
Antibiotic access in many markets is influenced more by price and logistics than by novelty or even clinical nuance. Our philosophy is to meet these pressures with scale, planning, and never at the expense of process. When global supply gets tight — floods disrupting raw material export from Asia, for instance — we ramp up production proactively, not reactively. It takes upstream communication with partner hospitals and public buyers, as well as clear supply compacts in advance.
By keeping our own warehousing close to high-usage centers and offering staggered delivery to synchronize with institutional inventory systems, we help prevent shortages without flooding local pipelines and causing waste.
Other producers may sell lower-grade material into secondary markets, relegating off-spec lots for animal or research use. We divert all off-spec Cefazolin Sodium for full destruction, not sideline sales. Internal guidelines require that every drum shipped stands up to full clinical scrutiny. This commitment to product integrity has cost us short-term sales at times, but it ensures that every partner — from seasoned pharmacists to first-responder nurses — can administer our product without doubt.
Whether supplying a regional hospital system or international procurement program, we never break the cold chain, allow unlabeled lots to move, or blend batches to hit a number. Our quality system is built around process discipline, frontline accountability, and seeing ourselves as partners in the realities of patient care, not just API suppliers.
Antibiotics like Cefazolin Sodium lack the flash of newer drugs, yet they hold together the everyday practice of medicine around the world. As bacterial resistance continues to change the treatment landscape, and as regulatory expectations climb, the market will demand not just more product, but better product, every year.
As a manufacturer, we respond to these demands by backing every shipment with transparent data, manufacturing rigor, and a relentless focus on the details that matter for real-world pharmacy and patient care. Cefazolin Sodium isn’t just made to specification — it’s made with hands-on pride, learnings from every batch, and an eye on the needs of the people who use it. That’s how we see our product, every day.