1,1’-hexamethylenebis[5-(p-chlorophenyl) biguanide] diacetate
C22 H30 Cl2 N10 . 2C2 H4 O2
SPECIFICATIONS AT RELEASE (EP)
|Description||White or almost white microcrystalline powder|
|Identification||Test A: The IR spectrum matches with the IR spectrum of the Eur.Ph. reference standard of Chlorhexidine Diacetate CRS|
|Chloroaniline||Not more than 500 ppm (regularly NMT 200 ppm at release)|
|Loss on drying||NMT 3.5%|
|Related Substances||Total impurities: NMT 2.5%|
|Sulphated Ash||NMT 0.15%|
|Assay||98.0%-101.0% (on dried substance)|
|PARTICLE SIZE (LASER DIFFRACTION)|
|STANDARD GRADE MATERIAL:
D(v,0.9): NMT 150 µm
|MICRONISED GRADE MATERIAL:
D(v,0.9): NMT 10 µm
25 Kg or 50 Kg net HDPE drums. Other sizes available upon request
Medichem performs ongoing stability studies on Chlorhexidine salts to ensure continuous quality throughout its shelf life. Stability data generated during more than 30 years of Chlorhexidine salts production have been used to set a shelf life of 5 years. Shelf life can only be guaranteed if the product is stored as indicated above.
– No special storage conditions are required.
– Keep in the original container tightly closed.
– Keep the drums away from direct sunlight.
REACH Regulation (EC) No. 1907/2006
The substance Chlorhexidine Diacetate has been preregistered according to REACH requirements. No registration number is given for this preregistered substance since the transition period for its registration according to Article 23 of REACH has not expired yet
Classified as hazardous substance according to transport regulations (class 9, UN 3077)