Raw Material Local Anesthetic Series Bupivacaine Hcl For Pain Killer 14252-80-3
Abstract
CAS:14252-80-3
MF:C18H28N2O.ClH
MW:324.89
EINECS:241-917-8
Melting point:249-2510C
storage temp. Refrigerator
Risk Statements 26/27/28
Safety Statements 22-36/37/39-45
RIDADR UN 2811 6.1/PG 2
WGK Germany 3
RTECS TK6125000
HazardClass 6.1(b)
Description:
Bupivacaine hydrochloride injection, USP is available in sterile isotonic solution for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. Solution of Bupivacaine hydrochloride injection, USP may be autoclaved. Solution is clear and colorless.
Bupivacaine hydrochloride USP is 2-Piperidinecarboxamide, 1-butyl-N-(2, 6-dimethylphenyl)-, monohydrochloride, monohydrate, a white, odorless, crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone.
Applications :
Bupivacaine is indicated for local infiltration, peripheral nerve block, sympathetic nerve block, and epidural and caudal blocks. It is sometimes used in combination with epinephrine to prevent systemic absorption and extend the duration of action. The 0.75% (most concentrated) formulation is used in retrobulbar block.
COA
| Items Tested |
Specification |
Result |
| Characters |
A white, crystalline powder or colorless crystals. |
A white crystal. |
| Identification |
IR should comply with the Reference Standard spectrum.
UV should comply with the Reference Standard spectrum.
An orange-red precipitate is performed. |
IR complies with the Reference standard spectrum.
UV complies with the Reference standard spectrum.
An orange-red precipitate is performed. |
| Melting range |
88 ~92 degree |
89.8-90.2degree |
| Loss on Drying |
Not more than 1.0% |
0.22% |
| Readily carbonizable Substances |
The resolution has no more color than Matching Fluid A. |
Conform |
| Residue on ignition |
Not more than 0.1% |
0.02% |
| Heavy metals |
Not more than 0.001% |
Conform |
| Chloride |
Conform |
Conform |
| Assay (HPLC) |
98.0%-102.0% |
99.96% |
| Ordinary Impurities |
≤1% |
Conform |
| Reaction |
Conform |
Conform |
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| 12) Bupivacaine hydrochloride |
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| 15) Lidocaine |
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| 16) Tetracaine |
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| 17) PROCAINE |
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