Rifampicin.

TEST                                  EQUIREMENTS/SPECIFICATIONS                     

Characteristics:                       A bright-red crystalline powder

slightly soluble in water,                          

soluble in methanol, slightly soluble

in acetone and alcohol                              

Identification:                  A:                                              

UV/VIS shows 4 absorptions (237nm, 254nm,

334nm and 475nm) maxima            

B: IR spectra should be as per ref. Standard         

C: reaction with persulphate                                                                 

Ph                              4.5 to 6.5                       

Related substances:

Rifampicin Quinone               Max.. 1.5 %                      

One peak:                       Max.. 1.0 %                         

Sum of peaks                    Max.. 3.5%                          

Heavy metals                    Max. 20 ppm                       

Loss on drying                   Max.. 1.0%                         

Sulphated Ash                   Max.. 0.1%                         

Assay                           97.0～102.0%                    

N-butyl alcohol                        <5000ppm                               

Total Viable Aerobic Count        ≤100CFU/g                         

Enterobacteria                   Absence                           

Pseudomonas Aeruginosa         Absence                            

Staphylococcus Aureus           Absence