← Active Pharmaceutical Ingredients
Rhexan International supplies Polymyxin B Sulfate USP — a polypeptide antibiotic active pharmaceutical ingredient (API) used in topical and ophthalmic pharmaceutical formulations. Manufactured by Hangzhou Zhongmeihuadong Pharmaceutical Jiangdong Co., Ltd and complying with USP standards, our material is supplied in 3.125 kg tins with full documentation.
Product Specifications
| Parameter | Specification |
|---|---|
| Product Name | Polymyxin B Sulfate |
| Internal Code | X-8 |
| CAS Number | 1405-20-5 |
| Grade | USP (Complies with USP QA-QS-J015-04) |
| Appearance | White or off-white powder |
| Assay (on dried basis) | ≥6000 U/mg |
| pH (0.5% solution) | 5.0–7.5 |
| Loss on Drying | ≤7.0% |
| Residue on Ignition | ≤5.0% |
| Single Impurity | ≤3.0% |
| Total Impurities | ≤17.0% |
| Polymyxin B3 (HPLC) | ≤6.0% |
| Polymyxin B1-I (HPLC) | ≤15.0% |
| Sum B1+B2+B3+B1-I (HPLC) | ≥80.0% |
| EDTA | ≤0.15% |
| Particle Size <20 μm | >99.0% |
| Particle Size <15 μm | >90.0% |
| Particle Size <10 μm | >75.0% |
| Particle Size <5 μm | >35.0% |
| Packaging | 3.125 kg/tin |
About Polymyxin B Sulfate
Polymyxin B Sulfate is a polypeptide antibiotic derived from Bacillus polymyxa, active primarily against gram-negative bacteria including Pseudomonas aeruginosa and Enterobacteriaceae. It is widely used as an active ingredient in topical antibiotic creams, ointments, ophthalmic drops, and ear preparations. The sulfate salt form provides good aqueous solubility and stability. USP-grade material meets strict purity, potency, and particle size requirements suitable for pharmaceutical manufacturing.
Applications
- Topical antibiotic formulations (creams, ointments, sprays)
- Ophthalmic and otic (ear) drops and solutions
- Combination antibiotic products (e.g., with neomycin or bacitracin)
- Veterinary pharmaceutical preparations
Manufacturer
Hangzhou Zhongmeihuadong Pharmaceutical Jiangdong Co., Ltd — No. 7278 Meilin Avenue, Dajiangdong Industrial Cluster Zone, Hangzhou, China. Tel: 0571-82907218.
Request a Quote
Contact Rhexan International for pricing, lead times, and availability of Polymyxin B Sulfate USP. We supply pharmaceutical manufacturers and compounding pharmacies across North America with full documentation including COA, SDS, and regulatory support.