泼尼卡酯

                               CERTIFICATE  OF  ANALYSIS

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      PRODUCT:         PREDNICARBATE

         BATCH NO.:         20181003        DATE OF MFG.:   OCT.23,2018             

         DATE OF ISSUE:  OCT.23, 2018        REPORT NO．：   2018102309          

        APPEARANCE:  WHITE OR ALMOST WHITE POWDER

      TESTING ITEM       SPECIFICATIONS         RESULTS

         IDENTIFICATION  

1) IR                      POSITIVE                POSITIVE

2) TLC                    POSTIVIE                POSITIVE

        LOSS ON DRYING            0.5%MAX                  0.12%

         OPTICAL ROTATION          +60°~+66°                 +64.17°

        RELATED SUBSTANCES(HPLC)

          IMPURITY B                0.2%MAX                 0.017%

          IMPURITY C                0.5%MAX                 0.200%

          IMPURITY D                0.2%MAX                 0.038%

           IMPURITY E                0.3%MAX                  0.108%

          IMPURITY F                0.8%MAX                 0.103%

          EACH IMPURITY           0.1%MAX                  0.039%

          TOTAL IMPURITY          2.0%MAX                  0.427%

        ASSAY                     97.0%~102.0%              99.44%

        RESIDUAL SOLVENT

          IPA                       5000PPM MAX               N.D

• HEXANE                290PPM MAX              58 PPM

EA                        5000PPM MAX             372 PPM

CHLOROFORM            60PPM MAX                 N.D

ACETIC ACID              5000PP MAX                N.D

PYRIDINE                 200PPM MAX                N.D

      STORAGE CONDITION:    PRESEVE IN HERMETICALLY SEALED CONTAINERS,

PROTECED FROM LIGHT, STORED IN A COOL  AND DRY PLACE.