|
HS Code |
220048 |
| Name | Colistin sulfate |
| Cas Number | 1264-72-8 |
| Chemical Formula | C52H98N16O17S2 |
| Molecular Weight | 1155.36 g/mol |
| Appearance | white to off-white powder |
| Solubility | soluble in water |
| Storage Temperature | 2-8°C |
| Antibiotic Class | polymyxin |
| Usage | treatment of infections caused by Gram-negative bacteria |
| Route Of Administration | oral, topical, or parenteral |
| Mechanism Of Action | disrupts bacterial cell membrane |
| Pharmacopoeia Status | listed in USP and EP |
As an accredited Colistin sulfate factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | Colistin sulfate is packaged in a sealed, amber glass vial containing 10 grams of white to off-white crystalline powder, labeled for laboratory use. |
| Container Loading (20′ FCL) | Colistin sulfate: 20′ FCL loads approximately 10,000–12,000 kg, packed in fiber drums or cartons, ensuring moisture-free, secure transport. |
| Shipping | Colistin sulfate is typically shipped as a stable, dry powder in tightly sealed, chemical-resistant containers to prevent moisture absorption and contamination. It should be stored and transported under cool, dry conditions, away from incompatible substances. Proper labeling, packaging, and documentation in compliance with regulatory requirements is essential for safe shipment. |
| Storage | Colistin sulfate should be stored in a tightly closed container, protected from light and moisture. Keep it at a temperature between 2°C and 8°C (refrigerated conditions), and avoid freezing. Ensure the storage area is well-ventilated and secure, away from incompatible substances. Follow appropriate regulations for hazardous chemicals, and keep out of reach of unauthorized personnel. |
| Shelf Life | Colistin sulfate typically has a shelf life of 2-3 years when stored in a tightly sealed container at 2-8°C, protected from light. |
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Purity 98%: Colistin sulfate with 98% purity is used in pharmaceutical formulations, where it ensures high antimicrobial efficacy against multidrug-resistant Gram-negative bacteria. Molecular weight 1,155 Da: Colistin sulfate with a molecular weight of 1,155 Da is used in intravenous antibiotic therapy, where it facilitates optimal bioavailability for systemic infections. Stability temperature 25°C: Colistin sulfate stable at 25°C is used in hospital storage conditions, where it maintains its antimicrobial potency over extended periods. Particle size <10 µm: Colistin sulfate with particle size less than 10 µm is used in inhalation therapy for cystic fibrosis, where it achieves efficient deep lung deposition. Solubility in water 50 mg/mL: Colistin sulfate with water solubility of 50 mg/mL is used in liquid injectable preparations, where it enables convenient and rapid drug administration. Endotoxin level <0.25 EU/mg: Colistin sulfate with endotoxin level below 0.25 EU/mg is used in endotoxin-sensitive research, where it reduces the risk of pyrogenic reactions in cell culture assays. Melting point 156°C: Colistin sulfate with a melting point of 156°C is used in high-temperature manufacturing processes, where it remains physically stable without degradation. Residue on ignition <0.1%: Colistin sulfate with residue on ignition less than 0.1% is used in sterile dosage manufacturing, where it minimizes particulate contamination risk. Assay ≥99%: Colistin sulfate with assay value at or above 99% is used in critical care antimicrobial therapy, where it delivers consistent dosing and reliable therapeutic outcomes. pH 5.0–7.5 (1% solution): Colistin sulfate with pH 5.0–7.5 in a 1% solution is used in intravenous infusions, where it ensures compatibility with physiological conditions and patient safety. |
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Every production batch in our facility tells a story about what goes into creating colistin sulfate. This compound stands as one of the most scrutinized antibacterial agents in veterinary medicine. Colistin sulfate has earned its reputation through decades of clinical trials, successes, heated debate, and regulatory attention. Instead of glossing over its profile, we see colistin sulfate as a benchmark for quality control, specialization, and transparency in how antibiotics reach customers.
Years ago, antimicrobial research started converging on the polymyxin class. Colistin sulfate, or polymyxin E sulfate, soon emerged as a leading molecule. Our staff handles the fermentation, purification, and crystallization steps in a contained environment, avoiding shortcuts. Colony-forming bacteria can introduce unwanted variations in the active compound if not checked carefully. Each deviation affects not just compliance but, more importantly, animal health outcomes.
Teams in our quality testing rooms consistently track colistin sulfate via high-performance liquid chromatography and rigorous bioassays. Each gram tells us whether the process met internal specifications—purity, moisture levels, assay limits, and absence of residual solvents. Producers with less robust testing often release batches with variable content or trace impurities. We set benchmarks because farm veterinarians read the report sheets closely, and down-the-line mistakes cost lives and reputations.
We manufacture colistin sulfate at a consistent specification of 98.0%-102.0% assay by dry basis, with moisture content controlled below 6%. Our process targets a fine, nearly white powder, odorless, and entirely soluble in water while insoluble in most organic solvents. This purity ensures that mixing into feed premixes or reconstituting for liquid administration yields consistent dosing, batch after batch.
Some believe that any colistin product “does the job,” but even minor differences in content or clarity affect farm-level decisions. Feed mills look for flowability and limit caking in bulk storage; veterinarians require full solubility in water to ensure quick delivery to livestock. These functional details speak louder than broad brush claims of “meets standards.” There is no pride in quick turnover if the product drifts from the mark. Our workforce monitors every shift, knowing that micron-level changes in particle size affect how colistin sulfate behaves in dispensers and mixers.
The pharmaceutical path for colistin diverges sharply at the point of salt formation. Markets often compare colistin sulfate to colistimethate sodium. The biggest difference lies in their chemical stability and target species. Colistin sulfate, due to its sulfate counterion, offers greater chemical stability during high-humidity feed mixing and maintains its structure at normal storage temperatures. Colistimethate sodium, on the other hand, tends to be used in human medicine because of its lower toxicity profile and parenteral compatibility. One does not substitute neatly for the other, especially when production standards or intended use fall under regulatory scrutiny.
Some manufacturers in markets with loose oversight cut corners by introducing blends or lower-grade materials. These often lead to uneven antibacterial activity, increased risks of resistance, and fines if caught at customs or by regulators. As producers, we invest in traceability from raw material origin through final packaging; this brings confidence to our customers, who know that quality hasn’t been diluted for volume.
Antibiotic stewardship is not just a slogan; regulators and international bodies enforce strict standards. Our facility monitors every receipt of raw materials, tracing back supplier lots for sustainability and documentation. Workers on our team see firsthand how improper handling in storage bins, pneumatic transfer lines, or blending vessels can lead to residual cross-contamination. We keep test logs going back several years for every finished lot.
Import checks and regulatory spot audits reinforce why process discipline ranks so highly. Bulk antibiotic shipments sometimes get held up due to paperwork discrepancies or missing assay results. Our approach prioritizes completeness and accuracy, so a farm waiting on medicated feed does not see delays due to rejected product. This responsibility weighs heavily in the minds of our lab teams, not just in the policies hanging in the office.
Small variations in processing—over-drying, prolonged mixing, or ambient humidity—can alter water solubility and impact how well an entire truckload mixes into feed. There’s no shortcut for this chemistry. Loose powder density and granulometry also affect how colistin sulfate migrates and blends, especially in automated feeder lines used in poultry and swine houses. The feedback loop from veterinarians, farmers, and regulatory reviewers shapes our daily process adjustments.
Feed manufacturers and large animal operations rely on colistin sulfate to address infections caused by Gram-negative bacteria such as E. coli and Salmonella. Field practitioners choose our product for poultry, swine, calves, and even certain aquaculture settings. Water-soluble dosing, administered through drinking systems, remains a preferred route on most farms because it delivers the antibiotic to a large group with minimal handling stress.
In-feed applications require high mixability. Our formulation ensures each microgram distributes evenly through premixes and complete feed. Skipping this detail results in overdosed or underdosed animals—something our plant operators and process engineers spend years refining. Poorly manufactured product could leave residues along feeding systems, reducing actual intake and compromising treatment success. End users—veterinarians and farm managers—call every season for detailed mixing and administration guidance, not just technical sheets.
Colistin sulfate does not act against all pathogens, and its limited spectrum suits cases of confirmed Gram-negative infection after sensitivity testing. Using lab-confirmed pathogens as guidance, our customers know precisely when and how long to apply colistin sulfate, minimizing unnecessary exposure and resistance risk.
The emergence of mcr-1 and similar resistance determinants in bacteria forced a reckoning on colistin use. Governments and global organizations imposed strict limits, particularly in food-animal medicine. We responded by establishing stewardship programs and providing detailed traceability logs, antimicrobial consumption registries, and annual reporting to relevant agencies.
Every product batch gets tested for antimicrobial activity, contamination, and correct labeling. Field teams regularly communicate feedback from users back to the lab, where scientists monitor for any hints of reduced activity. Working directly with veterinarians and regulators, we promote responsible usage: lowest effective dose, short treatment windows, and a total ban on off-label use outside regulatory allowances. Clear record keeping and real-time investigation of any reported treatment failures form our backbone of post-market surveillance.
Raw material procurement defines everything that follows. The best colistin sulfate batches come from trusted industrial fermentation groups, mostly using Paenibacillus polymyxa strains. Every shipment receives barcoding and quality credentials before entering our closed-system production lines.
Manufacturing uses a controlled fermentation environment, with precise temperature, aeration, and substrate feeding schedules. Downstream, we use multi-step purification to eliminate by-products and inactive forms. Technicians in our lines monitor chromatography outputs, fine-tune pH, and track temperature to avoid product degradation. Packaging teams conduct double checks, ensuring desiccant placement balances moisture control with actual customer use patterns. Every packed drum or bag contains a sample pouch for independent lab confirmation.
Investing in people and equipment, not just protocols, helps catch deviations faster. Operators participate in regular training—audits, safety, complaint response drills—and contribute feedback based on actual use conditions reported from the field.
Direct feedback from customers drives much of how we modify or upgrade production. Veterinarians, nutritionists, and farm managers often call about solubility in challenging local water conditions or unexpected physical changes during mixing. Each report triggers a follow-up—batch tracking, retention sampling, and, if warranted, a site visit to watch mixing methods live. Several years ago, a large poultry integrator flagged unusual caking in their feeders during a humid spell. Our team investigated, found localized particle-size variation from a single shift, and recalibrated the sifter assembly immediately.
We treat every complaint as a learning step, not just a quality checkpoint. Some customers need technical teams onsite to show the correct incorporation into their water or feed systems. We collect feedback and use it during staff training, reinforcing practical troubleshooting skills. In busy livestock operations, a seemingly minor variation in flow or mixability can spell lost productivity or regulatory trouble.
Market volatility—pandemic waves, port slowdowns, or regulatory delays—affects antibiotic shipments differently than commodities. We maintain an inventory that balances prompt customer supply with strict stock turnover guidelines. Our warehouse tracks each lot, facilitating fast dispatch and traceability for every outgoing batch. Packaging standards align with both international transportation needs and on-site handling at the farm or feed mill.
During global logistics shocks, our production planners work double shifts to adjust output schedules. Customers get honest schedules and clear shipment documentation. We’ve discovered that transparent communication and reliable documentation trump any price-based advantage in critical scenarios—nobody wants to gamble with animal health during an outbreak.
Every kilogram of colistin sulfate carries environmental responsibilities. Wastewater from fermentation passes through biological treatment stages. Our teams monitor COD, BOD, and heavy metal contamination, exceeding local requirements. By-product streams undergo separation and stabilization before secure disposal or authorized third-party treatment.
We invest in process optimization not just for yield, but for minimizing environmental impact. Newer reactors operate at lower energy loads with closed-loop solvent recovery. We track water, energy, and chemical consumption per batch, aiming to reduce the overall footprint without compromising final product assurance.
Neighbors—both farm and urban—expect us to handle odors and emissions professionally. Complaints trigger immediate investigation, and mitigation always comes before regulatory action. It’s a balance between industrial scale and community trust, and we treat it as a shared obligation.
The rules surrounding colistin sulfate grow stricter every year. End users expect each lot to meet not only pharmacopeial standards (usually Ph. Eur. or USP depending on region), but also emerging residue limits and documentation around antimicrobial use. Our regulatory compliance staff keep up with shifting national and global standards, revising labels, tick-box documents, and registration files as requirements evolve.
Regulators demand batch history, active content verification, detailed impurity profiles, and increasingly insist on documentation of resistance genes in fermentation starters. We provide all this, and proactively recall any product if health authorities raise alert levels about resistance outbreaks or potential safety signals traced to antibiotic use.
Our financing and production investment choices reflect not only market demand, but the rising bar for ethical antibiotic manufacture. We invest annually in staff retraining, upgrading equipment, and participating in responsible medicine forums. No commercial benefit outweighs the risk posed by one defective batch.
While demand for colistin sulfate remains high where regulatory frameworks allow, responsible producers shoulder a unique burden. More customers now request detailed traceability, support for responsible usage programs, and ongoing education for veterinarians and farm staff.
Researchers increasingly focus on reducing unnecessary antibiotic use and developing alternatives. We invest both in antimicrobial stewardship outreach and collaborative trials for non-antibiotic growth promoters or infection control tools. This transition takes time, but we recognize it as necessary to sustain both animal health and business integrity.
Our reputation relies on open data, real responsiveness to feedback, and production teams who see themselves as responsible partners—not faceless suppliers. Each jar or drum of colistin sulfate is backed by transparent documentation, manual oversight, independent test results, and a willingness to answer tough questions.
Long-term, the market for colistin sulfate will only reward companies that prioritize openness, product security, and responsible use. Each year brings new lessons, and our goal remains to set an example for quality in everything we manufacture, recognizing the stakes each time our product goes into the field.