Test Items                                Specifications                                    Results    

Characters             Purple red to purple black powder         Meet the test

Indentification                            IR&HPLC                                 Meet the test  

Solubility                Soluble in methanol and chloroform

                                slightly soluble in ethanol                          Meet the rest

                                practically insoluble in water

Sulfated ash                              NMT0.3%                                         0.05%

Water                                           NMT 2.5%                                        1.3% 

Limit of N-Iso                             NMT 0.3%                                        0.21%

butylpiperidone

Residual solvents

(A)Tetrahydrofuran                   NMT0.072%                                  0.012%

(B)Dichloromethane                NMT0.06%                            Not detected

(C)Hexane                                  NMT0.029%                                 0.0017%

(D)2-Methoxyethanol                NMT0.005%                              Not detected

Chromatopraphic Purity

(A)Each individual impurity at         (A) NMT 1%              (A) 0.02%, 0.05%

about RRT 0.5,0.6,0.8 and                                                    0.12%, 0.36%

1.4 with respect to Rifabutin                   

(B)Each other individual impurity      (B) NMT 0.5%            (B) Meet the Test

                                                                                                               (0.31%)

(C)Total Impurity                                 (C) NMT 3.0%                (C) 1.6%

 

Assay (C46H62N4O11)

On anhydrous basis                 96.0% to 102.0%                          98.1%