Gamithromycin

Character

A white or almost white powder,odorless,bitter taste,slightly hygroscopic

Very soluble in chloroform ,soluble in methanol and hydrochloric, dissolved in ethanol, slightly soluble in acetonitrile, practically insoluble in water

Specific rotation should be -38°to -42°

Melting point should be 173℃ - 179℃

Identification

IR Spectrum should be consistent with the Atlas of the control product

In the chromatographic chart recorded uner the content determination, the retention time of the main peak of the sample solution should be consistent with the retention time of the main peak of the control solution

Clarity and color of ethanol solution

Should comply with requirement

Related substances

9-deoxo-8o-aza-8o homoerythromycin A ≤0.2%

Other maximum Elementary substance ≤0.2%

Total impurities ≤2%

Remaining solvent

Should comply with requirement

Water

 ≤2%

Residue on ignition

 ≤0.1%

Metal

≤0.002%

Assay

98% - 102%