E-mail: info@rockypharm.hk
- All
- Product Name
- Product Keyword
- Product Model
- Product Summary
- Product Description
- Multi Field Search
 |
| Product information |
Product name | Polymyxin B Sulphate |
CAS No. | 1405-20-5 |
Molecular Formula | C56H100N16O17S |
Molecular Weight | 1301.56 |
Quality Standard | USP current, WC, DMF |
| COA Of Polymyxin B Sulphate |
Test items | Specification | Test results |
Appearance | White to buff - colored powder. Is odorless or has a faint odor. | White powder, odorless |
Identification - HPLC | The retention times of the major peaks from the sample solution correspond to those of the standard solution, as obtained in the test for purity of polymyxins. | Conforms |
Identification - Sulfate reaction | A white precipitate is formed. | Conforms |
Identification - Cupric sulfate test | A reddish - violet colour is produced. | Conforms |
pH (USP) | 5.0 - 7.5 | 6.1 |
pH (EP) | 5.0 - 7.0 | 5.8 |
Loss on drying | ≤7.0% | 2.9% |
Sulphated Ash | ≤0.75% | 0.26% |
Sulphate | 15.5% ~ 17.5% | 15.6% |
Optical Rotation | -78° ~ -90° (dried basis) | -83° |
Assay (Anhydrous) | ≥6000IU/mg | 7821IU/mg |
Related substance - Any impurity | ≤3.0% | 2.0% |
Related substance - Total impurities | ≤17.0% | 7.7% |
Purity - sum | NLT80.0% | 91.8% |
Purity - B3 | NMT6.0% | 1.0% |
Purity - B1 - I | NMT15.0% | 8.3% |
Microbiological examination - TAMC | ≤10cfu/g | Conforms |
Microbiological examination - TYMC | ≤10cfu/g | Conforms |
Microbiological examination - Staphylococcus aureus | undetected | Conforms |
Storage | Preserve in tight, light - resistant containers | - |
CONCLUSION | This product conforms with Current USP and In - house specification | - |
Polymyxin B Sulfate – High-Purity API for Last-Line Antibacterial Therapies |
Polymyxin B Sulfate (CAS 1405‑20‑5) is a potent Polymyxin B antibiotic active against multidrug-resistant Gram-negative infections, especially Pseudomonas aeruginosa, Acinetobacter baumannii, and Klebsiella pneumoniae. Our API-grade Polymyxin B is manufactured under strict GMP conditions with a focus on purity, safety, and clinical efficacy—making it ideal for formulations such as Polymyxin B injection, Polymyxin B ointment, and Polymyxin B topical eye drops for Pseudomonas eye infection.
Advanced Manufacturing Process |
Strain Selection & Fermentation
We utilize a high-yield strain of Bacillus polymyxa cultivated in controlled bioreactors to maximize the production of Polymyxin B1 and B2, the two active components of Polymyxin B Sulfate. Real-time pH and aeration controls ensure consistent biosynthesis across batches.
Extraction & Purification
After fermentation, the broth undergoes acid precipitation and multi-stage purification, including ion-exchange chromatography and membrane filtration. These steps ensure compliance with global pharmacopoeial standards while minimizing residual impurities—essential for Polymyxin B sulfate use in sepsis due to Pseudomonas aeruginosa.
Endotoxin Control
To meet the safety requirements for injectable use and extracorporeal therapies, our process includes endotoxin removal columns and ultrafiltration, supporting use in Polymyxin B sulfate endotoxin adsorption cartridge therapy.
Micronization & Final Processing
The purified product is micronized, sterilized, and freeze-dried to ensure compatibility with sterile formulations. This makes our API suitable for Polymyxin B dosing guidelines intravenous and intrathecal administration protocols.
Application Relevance |
Polymyxin B injection and intrathecal formulations are critical in ICU protocols for carbapenem-resistant infections.
Ophthalmic formulations benefit from our high-purity standard, meeting stringent specifications for Polymyxin B topical eye drops for Pseudomonas eye infection.
Our documentation and impurity profiling address concerns around Polymyxin B nephrotoxicity risk and monitoring and Polymyxin B side effects kidney neurotoxicity monitoring, helping formulators comply with global regulatory standards.
Resistance & Clinical Utility |
Understanding how polymyxin B works on bacterial cell membrane—by binding to lipopolysaccharides and disrupting membrane integrity—is essential for effective application in antibiotic stewardship programs. Our API supports strategic treatment planning, including Polymyxin B vs colistin antibiotic resistance management.
| Product information |
Product name | Polymyxin B Sulphate |
CAS No. | 1405-20-5 |
Molecular Formula | C56H100N16O17S |
Molecular Weight | 1301.56 |
Quality Standard | USP current, WC, DMF |
| COA Of Polymyxin B Sulphate |
Test items | Specification | Test results |
Appearance | White to buff - colored powder. Is odorless or has a faint odor. | White powder, odorless |
Identification - HPLC | The retention times of the major peaks from the sample solution correspond to those of the standard solution, as obtained in the test for purity of polymyxins. | Conforms |
Identification - Sulfate reaction | A white precipitate is formed. | Conforms |
Identification - Cupric sulfate test | A reddish - violet colour is produced. | Conforms |
pH (USP) | 5.0 - 7.5 | 6.1 |
pH (EP) | 5.0 - 7.0 | 5.8 |
Loss on drying | ≤7.0% | 2.9% |
Sulphated Ash | ≤0.75% | 0.26% |
Sulphate | 15.5% ~ 17.5% | 15.6% |
Optical Rotation | -78° ~ -90° (dried basis) | -83° |
Assay (Anhydrous) | ≥6000IU/mg | 7821IU/mg |
Related substance - Any impurity | ≤3.0% | 2.0% |
Related substance - Total impurities | ≤17.0% | 7.7% |
Purity - sum | NLT80.0% | 91.8% |
Purity - B3 | NMT6.0% | 1.0% |
Purity - B1 - I | NMT15.0% | 8.3% |
Microbiological examination - TAMC | ≤10cfu/g | Conforms |
Microbiological examination - TYMC | ≤10cfu/g | Conforms |
Microbiological examination - Staphylococcus aureus | undetected | Conforms |
Storage | Preserve in tight, light - resistant containers | - |
CONCLUSION | This product conforms with Current USP and In - house specification | - |
Polymyxin B Sulfate – High-Purity API for Last-Line Antibacterial Therapies |
Polymyxin B Sulfate (CAS 1405‑20‑5) is a potent Polymyxin B antibiotic active against multidrug-resistant Gram-negative infections, especially Pseudomonas aeruginosa, Acinetobacter baumannii, and Klebsiella pneumoniae. Our API-grade Polymyxin B is manufactured under strict GMP conditions with a focus on purity, safety, and clinical efficacy—making it ideal for formulations such as Polymyxin B injection, Polymyxin B ointment, and Polymyxin B topical eye drops for Pseudomonas eye infection.
Advanced Manufacturing Process |
Strain Selection & Fermentation
We utilize a high-yield strain of Bacillus polymyxa cultivated in controlled bioreactors to maximize the production of Polymyxin B1 and B2, the two active components of Polymyxin B Sulfate. Real-time pH and aeration controls ensure consistent biosynthesis across batches.
Extraction & Purification
After fermentation, the broth undergoes acid precipitation and multi-stage purification, including ion-exchange chromatography and membrane filtration. These steps ensure compliance with global pharmacopoeial standards while minimizing residual impurities—essential for Polymyxin B sulfate use in sepsis due to Pseudomonas aeruginosa.
Endotoxin Control
To meet the safety requirements for injectable use and extracorporeal therapies, our process includes endotoxin removal columns and ultrafiltration, supporting use in Polymyxin B sulfate endotoxin adsorption cartridge therapy.
Micronization & Final Processing
The purified product is micronized, sterilized, and freeze-dried to ensure compatibility with sterile formulations. This makes our API suitable for Polymyxin B dosing guidelines intravenous and intrathecal administration protocols.
Application Relevance |
Polymyxin B injection and intrathecal formulations are critical in ICU protocols for carbapenem-resistant infections.
Ophthalmic formulations benefit from our high-purity standard, meeting stringent specifications for Polymyxin B topical eye drops for Pseudomonas eye infection.
Our documentation and impurity profiling address concerns around Polymyxin B nephrotoxicity risk and monitoring and Polymyxin B side effects kidney neurotoxicity monitoring, helping formulators comply with global regulatory standards.
Resistance & Clinical Utility |
Understanding how polymyxin B works on bacterial cell membrane—by binding to lipopolysaccharides and disrupting membrane integrity—is essential for effective application in antibiotic stewardship programs. Our API supports strategic treatment planning, including Polymyxin B vs colistin antibiotic resistance management.
