Polymyxin B is primarily employed in the treatment of infections caused by multidrug-resistant Gram-negative bacteria, such as Acinetobacter baumannii and Pseudomonas aeruginosa. In quality-related studies, particular attention should be given to its potential renal and neurotoxic effects, as well as to the challenges associated with impurities, degradation products, and batch-to-batch stability encountered during manufacturing and testing processes.
Polymyxin B is an antibiotic widely regarded as a "last-resort" therapeutic agent in clinical practice. However, its quality assessment presents significant challenges due to complex composition, the presence of degradation products, potential toxicity risks, and stringent process control requirements. These challenges can be effectively addressed through the establishment of a comprehensive impurity profile, process optimization, and rigorous stability testing.
As Guangzhou PI PI Biotech Inc, a manufacturer with 15 years of specialized expertise in impurity research, we are capable of providing a full range of degradation impurities derived from process-related sources, long-term stability samples, accelerated stability samples, and forced degradation studies. We also offer complete structural characterization data, including HPLC, MASS, HNMR, CNMR, 2D-NMR techniques (such as COSY, HSQC, HMBC, and DEPT135), IR, TGA, QNMR, and SER. The product information is as follows:
| Catalog No. | Impurity Name |
| PI14004001 | Polymyxin B1 |
| PI14004002 | Polymyxin B1-1 |
| PI14004003 | Polymyxin B2 |
| PI14004004 | Polymyxin B3 |
| PI14004005 | Polymyxin impurity 1 |
| PI14004006 | Polymyxin impurity 2 |
| PI14004007 | Polymyxin impurity 3 |
| PI14004008 | Polymyxin impurity 4 |
| PI14004009 | Polymyxin impurity 5 |
| PI14004010 | Polymyxin impurity B |
| PI14004011 | Polymyxin impurity C |
| PI14004012 | Polymyxin impurity D |
| PI14004013 | Polymyxin impurity F |
| PI14004014 | Polymyxin impurity G |
| PI14004015 | Polymyxin impurity H2 |
| PI14004016 | Polymyxin impurity 6 |
| PI14004017 | Polymyxin impurity 6-1 |
| PI14004018 | Polymyxin impurity 7 |
| PI14004019 | Polymyxin impurity 7-2 |
| PI14004020 | Polymyxin impurity 7-3 |
| PI14004021 | Polymyxin impurity 8 |
| PI14004022 | Polymyxin impurity 9 |
| PI14004023 | Polymyxin impurity 10 |
| PI14004024 | Polymyxin impurity 11 |
| PI14004025 | Polymyxin impurity 12 |
| PI14004026 | Polymyxin impurity 13 |
| PI14004027 | Polymyxin impurity 14 |
| PI14004028 | Polymyxin impurity 15 |
| PI14004029 | Polymyxin impurity 16 |
| PI14004030 | Polymyxin impurity 16-1 |
| PI14004031 | Polymyxin impurity 17 |
| PI14004032 | Polymyxin impurity 18 |
| PI14004033 | Polymyxin impurity 19 |
| PI14004034 | Polymyxin impurity 20 |
| PI14004035 | Polymyxin impurity 7-1 |
| PI14004036 | Polymyxin impurity 20-2 |
| PI14004037 | Polymyxin impurity 6-2 |
| PI14004038 | Polymyxin impurity 21 |
| PI14004039 | Polymyxin impurity 22 |
| PI14004040 | Polymyxin impurity 23 |
| PI14004041 | Polymyxin impurity 24 |
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