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Colistin Sulfate Veterinary API

Colistin Sulfate Veterinary API

  • $40

    1-199 Kilogram

  • $35

    200-499 Kilogram

  • $30

    ≥500 Kilogram

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Product Attributes

Product Description

Colistin Sulfate for Veterinary API Applications

Colistin sulfate is a polymyxin E antibiotic complex produced by Bacillus polymyxa var. colistinus and supplied as a sulfate salt for pharmaceutical and veterinary applications. It is primarily sourced as a potency-standardized active ingredient for veterinary antimicrobial formulations, with quality assessment focused on identity, potency, sulfate content, moisture, and related substances.

What Is Colistin Sulfate?

Colistin sulfate is the sulfate salt of a mixture of closely related polymyxin peptide substances, principally colistin A and colistin B. Unlike a conventional single-molecule API, its quality is commonly expressed by antimicrobial potency and composition rather than by a single simple molecular-weight value. The compound is also known as polymyxin E or colistins sulfate.

Colistin sulfate has CAS number 1264-72-8. Official pharmacopoeial references describe it as a sulfate salt of antibacterial substances produced by the growth of Bacillus polymyxa var. colistinus. USP defines the material by a potency equivalent to not less than 500 micrograms of colistin per milligram, while the Japanese Pharmacopoeia expresses potency in units and specifies not less than 16,000 units per milligram on a dried basis.

Specifications

Item Specification
Product Name Colistin Sulfate
Product Category Veterinary API / Polymyxin E Antibacterial
CAS Number 1264-72-8
Synonyms Colistins sulfate; Polymyxin E; Colistin sulfate salt
Composition Sulfate salt of a mixture of colistin-related peptide substances, principally colistin A and colistin B
Representative Molecular Formula Colistin A sulfate: C53H100N16O13·2.5H2SO4; Colistin B sulfate: C52H98N16O13·2.5H2SO4
Representative Molecular Weight Colistin A sulfate: 1414.66 g/mol; Colistin B sulfate: 1400.63 g/mol
Typical Appearance White to pale cream powder
USP Potency Reference Equivalent to not less than 500 micrograms of colistin per milligram
Japanese Pharmacopoeia Potency Reference Not less than 16,000 units per milligram on a dried basis
Typical Commercial Potency Commercial specifications commonly use potency values in IU/mg; higher-potency specifications such as 19,000 IU/mg or above may be available depending on the material and test basis
Standard Test Method Pharmacopoeial identification and liquid chromatographic methods, together with microbiological potency testing as applicable
Typical Supporting Tests Sulfate content, loss on drying, pH, optical rotation, sulfated ash, related substances, and microbiological quality as applicable
Typical Shelf Life Commonly up to 24 months when stored in the specified conditions and original packaging
Storage Store in a cool, dry place, protected from excessive heat, moisture, and contamination; follow the applicable product specification for exact conditions
Packaging Common bulk packaging includes 1 kg or 5 kg inner foil bags and 25 kg fiber drums; customized packaging is available for qualified orders
Particle Size Customized according to formulation and processing requirements
Applications Veterinary pharmaceutical formulations, veterinary antimicrobial products, pharmaceutical manufacturing, and permitted research or formulation development

Key Benefits

  • Established polymyxin E API: Colistin sulfate is a recognized active pharmaceutical ingredient for veterinary antimicrobial applications.
  • Potency-based quality control: Because colistin sulfate is a mixture of related peptide components, potency is a particularly important procurement and release attribute.
  • Pharmacopoeial alignment: USP and other pharmacopoeial references provide defined approaches to identity and potency evaluation.
  • Suitable for bulk formulation: Standardized bulk material can support downstream veterinary pharmaceutical manufacturing where legally permitted.
  • Comprehensive incoming inspection: Buyers can evaluate potency alongside sulfate content, moisture, related substances, physical properties, and microbiological quality.

Applications

Veterinary Pharmaceutical Formulations

Colistin sulfate is used as an active ingredient in veterinary antimicrobial products. Selection should take into account the intended animal species, dosage form, approved use, target market, and applicable veterinary regulatory requirements.

Veterinary API Manufacturing

Colistin sulfate can be sourced as a bulk API for further manufacturing into permitted veterinary dosage forms. Potency basis, impurity profile, moisture, packaging, and analytical documentation should be established before commercial procurement.

Formulation Development and Analytical Work

Specified colistin sulfate materials may also be used in formulation-development or analytical applications where permitted. The selected specification should match the intended laboratory, development, or manufacturing purpose.

Buyer Decision Guide: Potency Units Matter More Than a Simple Purity Percentage

Colistin sulfate requires a different procurement approach from single-component small-molecule APIs. A specification stating only “high purity” does not adequately describe the material. Buyers should compare potency units, analytical basis, composition, moisture, and pharmacopoeial requirements before comparing quotations.

Procurement Focus What to Check Why It Matters
Potency IU/mg or micrograms of colistin per milligram, including whether the result is on a dried basis Potency is a key quality attribute for a peptide antibiotic mixture and directly affects formulation calculations.
Pharmacopoeial Standard Applicable USP, JP, or other recognized monograph and its analytical procedures Different standards may express potency and analytical requirements using different conventions.
Composition Colistin-related components and chromatographic profile where specified Colistin sulfate is not a simple single-component API, so chromatographic characterization can provide more useful information than a generic purity percentage.
Moisture Loss on drying or another validated water/moisture method Water content can affect the reported potency basis and batch-to-batch comparability.
Physical Handling Appearance, particle-size requirement, packaging, and storage conditions These parameters influence sampling, weighing, processing, and storage during downstream manufacturing.

For quotation comparison, the most useful approach is to normalize each supplier's result to the same potency basis and analytical standard. A reported IU/mg value should not be compared directly with a percentage assay without confirming what each number measures and whether moisture correction has been applied.

Why Choose This Product

  • Available as a bulk colistin sulfate API for veterinary pharmaceutical applications.
  • Potency-based specifications can be matched to the intended analytical and manufacturing requirements.
  • Standard and customized specifications are available according to qualified formulation needs.
  • Produced under GMP-standard conditions with in-house R&D and testing capabilities.
  • Per-batch testing can cover identity, potency, related substances, sulfate content, moisture, heavy metals, residual solvents, and microbiological quality as applicable.
  • COA, TDS, SDS, and relevant technical documentation can support procurement and incoming-quality review.
  • Customized packaging and bulk-order support are available for commercial manufacturing programs.
  • Global export experience supports international veterinary API procurement requirements.

Packaging Options

Common bulk packaging includes aluminum foil inner bags placed inside fiber drums, with commercial pack sizes such as 1 kg, 5 kg, and 25 kg. Packaging can be customized according to order quantity, transportation conditions, storage requirements, and downstream manufacturing processes.

OEM & Private Label

Colistin sulfate is a regulated veterinary pharmaceutical API rather than a conventional nutraceutical ingredient. Where permitted by the target market, related manufacturing services may include formulation development, finished-product manufacturing, packaging, labeling, and private-label production.

For regulated veterinary products, any customized formulation or finished product should be aligned with the applicable registration, approved specification, dosage form, labeling requirements, antimicrobial-use restrictions, and quality agreement.

Quality Control

Quality control for colistin sulfate should reflect its nature as a mixture of related polymyxin peptide substances. Typical batch-release and incoming-inspection controls include:

  • Identity verification using applicable pharmacopoeial or instrumental methods
  • Microbiological potency testing
  • Liquid chromatographic evaluation of composition and related substances where applicable
  • Sulfate content determination
  • Loss on drying or moisture determination
  • pH and other physical or chemical quality attributes where specified
  • Heavy-metal or elemental-impurity assessment where required
  • Residual-solvent testing where applicable
  • Microbiological quality testing according to the intended use
  • Appearance and packaging-integrity inspection

Frequently Asked Questions

What is the CAS number of colistin sulfate?

Colistin sulfate is commonly identified by CAS 1264-72-8. It represents a sulfate salt of colistin-related peptide substances rather than a conventional single-component small molecule, which is why commercial specifications commonly emphasize potency and composition.

How is colistin sulfate potency expressed?

Potency may be expressed in IU/mg or as an equivalent mass of colistin per milligram, depending on the applicable pharmacopoeial or validated method. USP specifies a potency equivalent to not less than 500 micrograms of colistin per milligram, while other standards may use different unit conventions.

Why is colistin sulfate not described by one simple molecular weight?

Colistin sulfate is a sulfate salt of a mixture of related peptide components, principally colistin A and colistin B. These components have different molecular formulas and molecular weights, so the commercial material is better characterized through composition, potency, and applicable pharmacopoeial testing.

How should colistin sulfate be tested before procurement?

Procurement review should normally cover identity, potency, chromatographic composition or related substances, moisture, sulfate content, appearance, and applicable microbiological quality. Buyers should also confirm the exact analytical standard and potency basis so that different supplier specifications can be compared consistently.

How should colistin sulfate be stored?

Colistin sulfate should be protected from excessive heat, moisture, contamination, and unsuitable handling. Storage conditions depend on the specific material and packaging configuration, so the applicable product specification and technical documentation should be followed for commercial storage.

Conclusion

Colistin sulfate is a potency-standardized polymyxin E API used primarily in regulated veterinary pharmaceutical applications. For bulk procurement, the critical sourcing variables are potency basis, pharmacopoeial standard, peptide composition, moisture, sulfate content, related substances, packaging, and the regulatory requirements of the destination market.

Contact us today to request samples, a COA, technical documents, and a wholesale quotation for colistin sulfate.

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Packaging & Delivery

Packaging & Delivery

Selling Units: Kilogram

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