Heparin Calcium

1.  Origin:                              

 Porcine intestinal mucosa

2.  Characteristics:                  

 A white or almost white

                                              

 moderately  hygroscopic

                                             

 powder

3.  Solubility:                          

 Freely soluble in water

4.  Identification Item A,C,D:  

 Positive

5.  Specific optical rotation:     

 ≥+35.0º

6.  Acidity or alkalinity(pH):    

 5.5～7.5(1% w/v solution)

7.  Appearance of solution:     

 Clear and colourless

8.  Heavy metals:                  

 ≤30 ppm

9.  Nitrogen:                          

 1.3～2.5%

10. Proteins:                          

 Meet requirements

11. Sodium:                          

 ≤0.1%
12.Calcium:  9.5～12.5%

13. Sulphur:                           

 ≥10.0%

14. Loss on drying:                 

 ≤5.0%

15. Sulfated ash:                    

 28.0～41.0%

16. Assay(Potency):              

 ≥140 USP U/mg

17. Light absorption:              

 A.0.4% w/v O.D.≤0.100 at 260nm

                                             

                    O.D.≤0.090 at 280nm

                                            

 B.5.0% w/v O.D.≤0.030 at 400nm

                                            

                    O.D.≤0.025 at 420nm

                                            

                    O.D.≤0.020 at 470nm

18. Microorganism:                 

 Bacteria≤100CFU/g

                                            

 Fungus ≤10CFU/g 

                                             

 Pathogenic bacteria: Free

19. Bacterial endotoxins:         

 ≤0.03 endotoxins  unit per usp

                                            

 heparin unit

20. Depressor  substances:    

 Free