Daptomycin

Off-White to Light Yellow Solid

Residue on ignition≤1.0%

Anhydro-daptomycin≤2.5%

β-Isomer≤ 2.0%

Lactone hydrolysis product≤1.5%

RS-2≤ 0.50%

Any other unknown impurity≤0.15%

Total impurities≤ 7.0%

Heavy metals≤30ppm

Water≤10.0% (K.F.)

Bacterial endotoxins<0.3EU/mg

Acetone≤5000ppm

Isopropanol≤5000ppm

Ethanol≤5000ppm

Butyl alcohol≤5000PPm

Assay (Dried bases)≥95.0%

Daptomycin is a kind of cyclic lipopeptide antibiotics with novel structure. It is extracted from the Streptomyces fermentation broth.  It not only having a novel chemical structure but also has mode of action which is different from any antibiotic approved before: it inhibits cell by disrupting the transport of amino acids through cell membrane, thereby blocking the cell wall peptidoglycan biosynthesis and changing the nature of the cell membrane. It can destroy the bacterial cell membrane function in many aspects, and quickly kill gram-positive bacteria. In addition to the role of taking effect on most clinically relevant gram-positive bacteria, more importantly, Daptomycin has a potent efficacy in treating isolated strains which have shown signs of resistance to methicillin, vancomycin and linezolid. This property is of great clinical significance to patients suffering from severe infection.