99% Bacitracin Zinc API With GMP/USFDA Approval
Bacitracin Zinc is a polypeptide antibiotic produced by Bacillus licheniformis and Bacillus subtilis (Bacillus Tracy strain). It is supplied as the zinc salt, which confers enhanced stability and a defined powder form suitable for topical and ophthalmic formulations.
We export high‑purity Bacitracin Zinc Active Pharmaceutical Ingredient (API), serving pharmaceutical manufacturers, generic drug developers, compounding pharmacies, and veterinary product companies worldwide.
We supply Bacitracin Zinc API (CAS 1405-89-6) manufactured under stringent cGMP guidelines, fully compliant with USP, EP, BP, and JP pharmacopeial standards.
Why Choose Us As Your Bacitracin Zinc API Supplier?
Industry Leader:
As the largest supplier of Bacitracin Zinc API in China, we guarantee unmatched quality for smooth manufacturing.
Trusted By Top 10 Pharmaceutical Companies:
Trusted by world-famous pharmaceutical companies in over eight countries, such as J&J, GSK, Pfizer, etc.
Quality Assurance:
We rigorously test every batch to ensure compliance with USP/EP standards and have non-negotiable refund policies for any quality issues.
Competitive Pricing:
You receive the best prices on pharma-grade bacitracin zinc API in China without compromising on quality.
Bacitracin Zinc API Applications and Specifications
Applications:
- Topical antibiotic creams and ointments
- Wound care products
Bacitracin zinc, the zinc salt of Bacitracin, is a cyclic polypeptide antibiotic.
It is primarily formulated as ointments or aerosol sprays containing polymyxin B sulfate, neomycin sulfate, and other ingredients. It is applied to minor cuts, scrapes, or burns to help prevent possible infections.
Bacitracin zinc is only effective against bacterial infections, not those caused by viruses or fungi.
Product Name: Bacitracin Zinc APIs (Bacitracin Zinc salt, zinc bacitracin, 杆菌肽锌)
Appearance: A white to pale tan powder
Cas Number: 1405-89-6
Molecular Formula: C66H101N17O16SZn
Molecular Weight: 1486.067 g/mol
Chemical Name: 4-[[2-[[2-(1-amino-2-methylbutyl)-4,5-dihydro-1,3-thiazole-4-carbonyl]amino]-4-methylpentanoyl]amino]-5-[[1-[[3-(2-amino-2-oxoethyl)-18-(3-aminopropyl)-12-benzyl-15-butan-2-yl-6-(carboxymethyl)-9-(4H-imidazol-4-ylmethyl)-2,5,8,11,14,17,20-heptaoxo-1,4,7,10,13,16,19-heptazacyclopentacos-21-yl]amino]-3-methyl-1-oxopentan-2-yl]amino]-5-oxopentanoic acid;zinc
HS Code: 2941909099 (Other antibiotics-其他抗菌素)
Suitability to be shipped by air as common goods: Suitable. It is safe to be shipped by air as common goods.
Grade: Pharma-Grade
Potency or Assay: 65IU/MG
Standards: Current USP Standards
Certificates available: WC/COPP
Documents Available: COA/MSDS/USDMF
Supply Capability: 20 tons per year
MOQ: 100G
Lead Time: 5~7 days for quantities less than 200KG, 3~4 days for orders less than 1000 kg.
Stock Status: Over 1000KG
Shipping Temperature: Room temperature
Storage: Room temperature
Why Import Bacitracin Zinc API From Us?
#1. High Quality:
Our USP-grade Bacitracin zinc API is registered and approved by the USFDA/EDQM, and WC is available.
Our manufacturing facility is regularly audited and verified by prominent companies, including J&J, Pfizer, and GSK.
#2. Quality Guarantee:
If there are any quality issues, you will receive a 100% refund.
Over the past seven years, our customers have had no quality issues.
For our regular customers, we are so confident in the quality that we offer credit to our VIP customers.
#3. Steady Supply:
Our stock exceeds 1000 kg, and we guarantee a stable supply of Bacitracin zinc API to ensure your ointment production is never disrupted.
Zinc Bacitracin API Manufacturing Process
Our Bacitracin Zinc API is produced through a controlled fermentation and purification process in a cGMP‑certified facility:
Fermentation – Bacillus licheniformis or Bacillus subtilis (Tracy strain) is cultivated in nutrient media under controlled conditions (pH, temperature, aeration) to optimize bacitracin production.
Harvest and isolation – The fermentation broth is acidified and filtered to remove biomass. Bacitracin is extracted using adsorption and elution techniques.
Purification – Multi‑step chromatography and selective precipitation remove impurities, including the toxic degradation product bacitracin F.
Zinc complexation – Purified bacitracin is reacted with a zinc salt (e.g., zinc chloride or zinc sulfate) to form the stable zinc complex, which precipitates as a fine powder.
Drying and milling – The wet cake is dried under controlled conditions (low temperature, vacuum) to preserve potency, then milled to achieve the desired particle size.
QC Release Testing – Each batch is tested for potency (microbiological assay), zinc content, bacitracin F levels, loss on drying, and microbiological purity in accordance with USP/EP monographs.
Quality emphasis – Stringent control of bacitracin F (the nephrotoxic degradation product) is a key differentiator of our product.
FAQs For Our Zinc Bacitracin API
#1. What are the quality standards of your bacitracin zinc API?
We typically issue Certificates of Analysis (CoAs) in accordance with USP-NF standards, as we primarily export bacitracin zinc API to North America.
Although our bacitracin zinc API meets EP standards, please note that we don’t test it in accordance with those standards.
#2. Do you have DMF for our MOH filing? If yes, what is the minimum order quantity required to provide DMF?
Yes, we have.
The MOQ for us to provide DMF is 50 KG.
#3. What is your packing size?
Our packing size for bacitracin zinc API is 10 kg per drum, as it is a micronized powder and tends to be fluffy.
#4. Do you offer custom particle size or formulation support?
Yes.
We collaborate with compounding pharmacies and manufacturers to customize particle size, solubility, or blend specifications for specific formulations.
Please contact our technical team to discuss your specific requirements.
#5. Can your bacitracin zinc API be used in sterile compounding?
Absolutely.
Our Bacitracin Zinc API is suitable for sterile compounding applications, provided it is processed in a controlled environment that adheres to USP or other relevant guidelines.
We supply it as a non-sterile-grade powder with low endotoxin levels for critical formulations.
#6. Are your manufacturing facilities GMP-certified?
Yes.
Our Bacitracin Zinc API is produced in GMP-certified facilities with ISO 9001:2015 accreditation.
We adhere to strict quality control protocols to ensure consistency and traceability from batch to batch.
#7. How do you ensure product safety for sensitive applications?
Each batch undergoes rigorous testing for heavy metals, residual solvents, and microbial contaminants.
We also conduct stability studies to validate shelf-life and storage recommendations.
#8. Can Bacitracin Zinc API be combined with other antibiotics?
Yes.
It often combines Neomycin or Polymyxin B for broad-spectrum antibiotic ointments. Our technical team can provide formulation guidance for combination products.
#9. Do you ship globally?
Yes. We serve API importers and compounding pharmacies worldwide, with compliant documentation for seamless customs clearance.
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