Product Name: Articaine hydrochloride
Appearance: White or white crystalline powder
Loss on drying: ≤ 0.2%
Septocaine (articane hcl and epinephrine injection) injection is a sterile, aqueous solution that contains articaine HCl 4% (40 mg/mL) and epinephrine bitartrate in an epinephrine 1: 200, 000 or epinephrine 1: 100, 000 strength. Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophenecarboxylic acid, methyl ester hydrochloride and is a racemic mixture. Articaine HCl has a molecular weight of 320.84.
Septocaine (articane hcl and epinephrine injection) contains articaine HCl (40 mg/mL), epinephrine (1: 200, 000 or 1: 100, 000) (as epinephrine bitartrate), sodium chloride (1.6 mg/mL), and sodium metabisulfite (0.5 mg/mL). The product is formulated with a 15% overage of epinephrine. The pH is adjusted with sodium hydroxide.
Articaine is a local anaesthetic that has been approved overseas for several years. Like other amide anaesthetics, articaine blocks nerve conduction when it is infiltrated around a nerve. This action is prolonged by combining the drug with a vasoconstrictor The combination of articaine can be used for local or regional anaesthesia for dental procedures. Anaesthesia begins within six minutes and lasts for an hour. The half-life of articaine is approximately 1.8 hours. It is metabolised and then mainly excreted in the urine.
|Test Items||Specification||Test Results|
|Description||White or almost white crystalline powder||White crystalline powder|
|Loss of drying||≤1.0%||0.5%|
|TLC||Only one spot||Only one spot|
|Conclusion||It complies with the USP 32.|