Bupivacaine HCL
Bupivacaine hydrochloride
CAS No.: 14252-80-3
Standard: USP/EP
Appearance: White powder
Bupivacaine hydrochloride
CAS No.: 14252-80-3
Standard: USP/EP
Appearance: White powder
| Test Items | Standard | Test Results |
|
Character
|
White crystalline powder
|
Conforms
|
|
Solubility
|
Very soluble in ethanol,
soluble in water
|
Conforms
|
|
Identification
|
|
Conforms
Conforms
|
|
PH
|
4.5 ~ 6.0
|
5.0
|
|
Heavy metal
|
Not more than 0.001%
|
Conforms
|
|
Water
|
4.0% ~ 6.0%
|
5.4%
|
|
Residue on ignition
|
Not more than 0.1%
|
0.07%
|
|
Limit of residual solvents
|
N,N-Dimethylformamide≤0.088%
Isopropyl alcohol ≤0.004%
|
Conforms
Conforms
|
| Chromatographic purity |
Any other impurity ≤ 0.5%
Total impurities≤ 2.0%
|
Conforms
Conforms
|
|
Assay (Calculated on the anhydrous basis)
|
98.5%~101.5%
|
99.4%
|