Applications: Teicoplanin is a glycopeptide antibiotic produced by fermentation of Actinobacteria. It is a ...    More ...

Applications:
Teicoplanin is a glycopeptide antibiotic produced by fermentation of Actinobacteria. It is a new generation of glycopeptide antibiotics developed after vancomycin and is one of the most promising antibiotics for combating drug resistance in clinical practice in China. Compared with vancomycin, it has stronger lipid solubility, a longer half-life, good fluid distribution, milder adverse drug reactions, and can be administered intravenously or intramuscularly, making it more convenient to use.
                                           Test Item                               
                                          Specification
                     
                                      Appearance
                                          White or faint yellow powder
                     
                                      Identification
                                          1、HPLC  the test solution should similar in retention time and size to the  reference solution                 
                     
                                      2、IR   should consistent with the IR spectrum of reference standard                 
                     
                                      Solution clarity and color
                

                                          Clarity ≤1#
                     
                                      Color ≤BY3 or B4
                     
                                      PH
                                          6.5～7.5
                     
                                      Sodium chloride
                                          ≤5.0%
                     
                                      Water
                                          ≤15.0%
                     
                                      Bacteria l endotoxins
                                          <0.31IU/mg
                     
                                      Composition    and Related
substances                 
                                          A2 group. ≥80%
                     
                                      A2-2 35.0%～55.0%
                     
                                      A2-1 group ≤20%
                     
                                      A2-3 group ≤20%
                     
                                      A2-4 group ≤20%
                     
                                      A2-5 group ≤20%
                     
                                      A3 group ≤15%
                     
                                      Impurity    A  ≤0.2%
                     
                                      Total    impurities ≤5.0%
                     
                                      Residual solvents
                                          Ethanol    ≤5000ppm
                     
                                      Acetone    ≤5000ppm
                     
                                      Microbial    limit                 
                                          TAMC ≤1000cfu/g
                     
                                      TYMC    ≤100cfu/g
                     
                                      Assay(anhydrous and sodium chloride-free   substance)
                                           ≥900IU/mg
                     
    
Less ...