Polymyxin B sulfate
Short Description:
Product Detail
Product Tags
Description:
Polymyxin B Sulfate is the sulfate salt form of polymyxin B, a mixture of the polypeptides polymyxins B1 and B2, both obtained from Bacillus polymyxa strains, with antimicrobial activity. Polymyxin B exerts its antimicrobial effect through its cationic detergent action on cell membranes. Specifically, this antibiotic binds to the negatively charged site in the lipopolysaccharide layer of the bacterial cell membrane via electrostatic affinity with the positively charged amino groups in the cyclic peptide portion. Subsequently, the fatty acid portion of polymyxin B dissolves in the hydrophobic region of the bacterial cell membrane. This results in an alteration in cell membrane structure, disruption of cell wall integrity and an increase in permeability for water and molecules. This will eventually lead to bacterial cell death.
A mixture of polymyxins B1 and B2, obtained from BACILLUS POLYMYXA strains. They are basic polypeptides of about eight amino acids and have cationic detergent action on cell membranes. Polymyxin B is used for treatment of infections with gram-negative bacteria, but may be neurotoxic and nephrotoxic.
CERTIFICATE OF ANALYSIS
| Product name: Polymyxin B Sulfate( sterile) | Report No.: LN20191001 | |||||
| Batch No:20191001 | Packing: 3.0kg/tin | Report Date: 21,Oct.,2019 | ||||
| Batch Size: 33kg | No. of Package: 11 tins | M.f.G Date: 02, Oct.,2019 | ||||
| According to: USP40 Monograph<Polymyxin B sulfate> | Retest Date: 01,Oct.,2022 | |||||
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Test items |
Specification |
Test results |
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| Appearance | White or almost white; hygroscopic powder. |
White hygroscopic powder |
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| Identification |
a)HPLC: The retention time of the major peaks of the sample solution correspond to those of the standard solution. |
Conforms |
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Color reaction with cupric sulfate solution: A reddish-violet color is produced. |
Conforms |
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Sulfate reaction: meet requirement |
Conforms |
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| PH | 5.0-7.5(20mg/ml) |
5.96 |
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| Loss on drying |
≤7.0% |
1.64% |
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| Sulphated Ash | NMT0.75% |
0.20% |
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|
Sulphate |
15.5%～17.5% |
16.26% |
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| Specific Optical Rotation |
-78～-90(dried basis) |
-84 |
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| Assay |
≥ 6000u/mg (Anhydrous) |
7695U/mg |
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| Related substance |
Any impurity: ≤3.0% |
2.50% |
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Total impurities: ≤17.0% |
11.39% |
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| Microbiological examination |
TAMC: ≤10cfu/g |
Conforms |
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TYMC: ≤10cfu/g |
Conforms |
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Staphylococcus aureus: undetected |
Conforms |
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| Purity-sum | NLT80.0% |
87.11% |
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| Purity-B3 | Max6.0% |
1.56% |
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Purity-B1-I |
Max15.0% |
9.05% |
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|
Pyrogen Test |
Meet the requirement |
Meet test |
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| CONCLUSION: This product conforms with USP40<Polymyxin B Sulfate> requirement. | ||||||
| Reported by: | Checked by: | QC Director: | ||||
