Glycerol(99.7%、85%) for injection:
complies with ChP、USP、EP、JP
Aldehyde and Ketone testing:
Glyceraldehyde:≤5 ppm
Dihydroxy acetone:≤5 ppm
Hydroxy acetone:≤5 ppm
Formaldehyde:≤2 ppm
Total reducing substance:≤10 ppm
Endotoxin testing:<0.001 IU/mg
Impurity testing:
Heavy metal:≤5 ppm
Bioburden(Sum TAMC/TYMC):≤100 CFU/g
Any related substance:≤0.1%
Total related substances:≤0.5%
Description of residual solvents:
There is no any class 1 and class 2 residual solvent, only one class 3 solvent is likely to be present. The level of this Residual solvent is less than 100 ppm. |