cytidine 5'-diphosphocholine sodium salt dihydrate

Details:

ITEM                        SPECIFICATION                             RESULT

Description:           A white odourless crystalline powder                       Complies

Solubility:                Soluble in water, insoluble in ethanol,acetone         Complies

Identification:

                                     1. Green colour reaction                                                    Complies

                                     2. Max. absorption at 280nm                                           Complies

                                     3. Min absorption at 240nm                                             Complies

                                     4.A280:A260=2.1-2.2                                                           2.1

                                     5.Phosphate salt reaction                                                 Complies

                                     6. Sodium salt reaction                                                       Complies

Clarity & color of solution: Clear & colorless                                                 Complies

PH:                                                          6.0-7.5                                                            6.5

Chloride:                                                       0.05% max                                                   Complies

Amonium salts:                                0.05% max                                                   Complies

Iron:                                                       0.01% max                                                   Complies

Free phosphates:                              0.1% max                                                     Complies

Related substances:                       

         5-CMP:                                         0.3% max                                                     0.0062%

         Single Impurity:                       0.2% max                                                     0.0018%

         Other Total Impurities:        0.7% max                                                     0.0035%

Loss on drying:                                  6.0% max                                                     1.05%

Heavy metals:                                    5ppm max                                                    Complies

As:                                                           1ppm max                                                    Complies

Yeast & Molds:                                   100cfu/g max                                             <10cfu/g

Total bacterial counts:                           1000cfu/g max                                          <10cfu/g

E-Coli:                                                    Not detected                                                Complies

Bacterial Endotoxines:                  0.3EU/mg                                                     Complies

Assay (as dry basis):                       98.0%-102.0%                                           100.2%

Residual Solvents:

         Methanol:                                   0.3% max                                                     Not detected

         Ethanol:                                      0.5% max                                                     Not detected

         Acetone:                                               0.5% max                                                     Not detected

Conclusion:  Comply With CP2015 Standard (Non-sterile)