Erythromycin Lactobionate Sterile

Description

Product Description Formula: C*7h*7no*3 CAS: ********8 White to almost white crystals or crystalline; No odor, bitter. Erythrocin lactobionate (sterile erythromycin lactobionate), is a soluble salt of erythromycin suitable for intravenous administration. It is available as a sterile, lyophilized powder in vials containing the equivalent of **0 mg or 1 g of erythromycin activity. Erythromycin lactobionate is chemically known as erythromycin mono (***-β -d-galactopyranosyl-d-gluconate) (salt). It is GMP approved. Item Specification Result Appearance White to almost white crystals or crystalline; no odor, bitter White to almost white crystals or crystalline; no odor, bitter Identification IR spectrum: corresponds to the standard IR spectrum: corresponds to the standard Solubility Meets requirements Conforms Acidity or Alkalinity PH6.**7.5 7.*4 Related Substances Meets requirements Conforms Loss on Drying Not more than 4.0% 2.9% Bacterial *****: Not more than 1.0 (***** Unit) per mg of erythromycin Conforms Sterility Meets requirements Conforms Assay Not less than **0 Unit of Erythromycin per mg **1u/mg(wet basis) **5u/mg(on anhydrous basis) Conclusion: This product conforms to requirements of CP***5