Detailed Product Description

TESTING ACCORDING AS: THE STANDARD OF STATE DRUG ADMINISTRATION (WS₁-(X-262)-2003Z)

ITEMS                SPECIFICATIONS                    RESULTS                 CONCLUSION

CHARACTER            A WHITE OR ALMOST WHITE TO        A ALMOST WHITE POWDER   CONFORM                                                                                                                                           

                     SLIGHTLY YELLOW POWDER

SPECIFIC OPTICAL     -55°-62°                     -57°                    CONFORM

ROTATION

ABSORPTIVITY         305335                          306                     CONFORM

IDENTIFICATION       CONFORM                           CONFORM                 CONFORM

pH                   5.57.5                          6.7                     CONFORM

CLARITY OF           NOT MORE INTENSE THAN             0.5                     CONFORM

SOLUTION             REFERENCE SUSPENSION 1#

COLOUR OF            NOT MORE INTENSELY COLOURED        5                       CONFORM

SOLUTION             THAN 9#

WATER                NOT MORE THAN 4.0%                2.4%                     CONFORM

HEAVY METALS         NOT MORE THAN 0.0020%             LESS THAN 0.0020%        CONFORM

RELATED              THE BIGGEST IMPURITY              0.1%                     CONFORM

SUBSTANCES           NOT MORE THAN 1.0%                

                     TOTAL IMPURITIES NOT MORE         0.3%                     CONFORM

                     THAN 1.5%

STERILITY            CONFORM                          CONFORM                   CONFORM

PYROGEN              CONFORM                          CONFORM                   CONFORM   

ASSAY CALCULATED   CONTAIN C₂₀H₂₀N₆O₇S₄                 102.4%                   CONFORM

AS THE ANHYDROUS     NOT LESS THAN 86.0%

BASIS