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Product Details
Item Name: prilocaine HCL CAS NO.: 1786-81-8
Apparence: White Powder
package: Aluminum Bag;Drums
Purity: 99%
Storage: Store in a tightly closed container and cool dry place where the temperature stays below 20℃
Certificate: ISO9001
Payment: T/T;Western Union
Prilocaine Hydrochloride is the hydrochloride salt form of prilocaine, an intermediate-acting local anesthetic of the amide type chemically related to lidocaine. Prilocaine hydrochloride binds to voltage-gated sodium ion channels in the neuronal membrane, thereby preventing the permeability of sodium ions. This leads to a stabilization of the neuronal membrane and inhibits depolarization and results in a reversible blockage of nerve impulse generation and propagation along nerve fibres and subsequent reversible loss of sensation.
Prilocaine Hydrochloride Injection, USP, 4% contains prilocaine HCl, which is chemically designated as propanamide, N- (2-methyl-phenyl) -2- (propylamino)-, monohydrochloride and has the following structural formula: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Certificate of Analysis
|
TEST |
SPECIFICATIONS |
RESULTS |
|
Characters |
A white or almost white |
Conform |
|
Identification |
A) IR graph should be concordant |
Conform |
|
Appearance of solution |
Solution S should not be more |
Conform |
|
pH |
4.5 to 5.5 |
5.1 |
|
Impurity A |
Not more than 100 ppm. |
Conform |
|
Related substances |
A) Impurities C and E (for each impurity): Not more than 0.2%. |
Conform |
|
Loss on drying |
Not more than 0.5% |
0.32% |
|
Heavy metals |
Not more than 10ppm |
Complies |
|
Sulphated ash |
Not more than 0.100% |
0.02% |
|
Assay |
98.0% ~ 102.0% |
99.97% |
|
Residual solvents |
|
|
|
BIOLOGICAL TESTS |
NOT MORE THAN 104 EU/g |
Conform
|
Dental anesthesia:Infiltration or conduction block: Initial: 40 to 80 mg (1 to 2 mL) as a 4% solution. AAPD guidelines, 2009 maximum recommended dose within a 2-hour period: <70 kg: 6 mg/kg (400 mg) ≥70 kg: 400 mg or 5 to 6 cartridges Note:The effective anesthetic dose varies with procedure, intensity of anesthesia needed, duration of anesthesia required and physical condition of the patient. Always use the lowest effective dose along with careful aspiration.
Dental anesthesia:Infiltration or conduction block: Children <10 years: Doses >40 mg (1 mL) as a 4% solution per procedure rarely needed for procedures involving a single tooth, in a maxillary infiltration for 2 to 3 teeth, or for an entire quadrant with a mandibular block. Children ≥10 years and Adolescents: Refer to adult dosing.
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