INS：235
Molecular weight：665.73
Molecular formula ：C20H41N4O3Cl
Molecular structural:
Natamycin is a tetraene polyene antibiotic derived from Streptomyces natalensis. It possesses in vitro activity against a variety of yeast and filamentous fungi, including Candida, Aspergillus, Cephalosporium, Fusarium and Penicillium. The mechanism of action appears to be through binding of the molecule to the sterol moiety of the fungal cell membrane. The polyenesterol complex alters the permeability of the membrane to produce depletion of essential cellular constituents. Although the activity against fungi is dose-related, natamycin is predominantly fungicidal. Natamycin is not effective in vitro against gram-positive or gram-negative bacteria. Topical administration appears to produce effective concentrations of natamycin within the corneal stroma but not in intraocular fluid. NATAPRO standard item compliance with USP42, Suitable for the preparation of eye drops, skin ointment and other drug.
Items |
Standard |
Description |
White to creamy-white powder and odorless |
Identification |
Complies with the requirements |
Solubility |
Pratically insoluble in water; slightly soluble in Methanol; soluble in Acetic acid and in Dimethylformamid. |
Assay(On dried basis) |
≥95.0% |
pH(1%aqueous solution) |
5.5～7.5 |
Loss on drying |
≤8.0% |
Ash |
≤0.5% |
Heavy metals(Total as Pb) |
≤10mg/Kg |
Arsenic |
≤3mg/Kg |
Lead |
≤2mg/Kg |
Mercury |
≤1mg/Kg |
Particle size |
100% less then 10μm |
Residual solvent Ethonal |
≤0.5% |
Total plate count |
≤100cfu/g |
Salmonella |
25g Negative |
Listeria monocytogenes |
25g Negative |
Specific rotation |
+250°～+295° |
■ 1kg/bottle ，10 bottles/carton
