Lidocaine Hydrochloride is the hydrochloride salt of lidocaine, a widely used local anesthetic and class Ib antiarrhythmic active pharmaceutical ingredient. It produces reversible loss of sensation by inhibiting voltage-gated sodium channels in excitable tissues.
Lidocaine Hydrochloride blocks sodium ion channels in neuronal cell membranes, preventing the initiation and propagation of action potentials. This produces local anesthesia when administered to the appropriate tissue. When used systemically under controlled clinical conditions, lidocaine also acts as a class Ib antiarrhythmic agent by reducing abnormal cardiac electrical activity.
Lidocaine Hydrochloride is a synthetic small-molecule compound with the molecular formula C14H23ClN2O·HCl and a molecular weight of approximately 270.80 g/mol for the anhydrous hydrochloride. Its CAS Number is 73-78-9.
It is a water-soluble salt of lidocaine and is widely used in pharmaceutical formulations, particularly injectable preparations, topical formulations and other dosage forms where local anesthetic activity is required.
Lidocaine Hydrochloride produces local anesthesia primarily through reversible blockade of voltage-gated sodium channels.
By preventing sodium influx through neuronal sodium channels, lidocaine inhibits depolarization and prevents the generation and propagation of action potentials along nerve fibers. This temporarily blocks transmission of pain signals.
At therapeutic systemic concentrations, lidocaine can also inhibit cardiac sodium channels and suppress certain ventricular arrhythmias.
Lidocaine Hydrochloride is used in pharmaceutical preparations for local or regional anesthesia and for topical relief of pain or irritation. Injectable formulations are used for local anesthesia during medical and dental procedures.
Lidocaine Hydrochloride is also used intravenously in selected clinical settings for the treatment of certain ventricular arrhythmias.
Lidocaine Hydrochloride API can be evaluated using validated analytical procedures for identification, assay, related substances, water content, residual solvents, elemental impurities and other applicable quality attributes.
Chromatographic and spectroscopic techniques may be used for identity, assay and purity determination. For injectable pharmaceutical products, additional controls may apply, including microbial quality, bacterial endotoxins, particulate matter and sterility according to the applicable finished-product specification.
Acceptance criteria should be based on the applicable manufacturer's drug-substance specification, Certificate of Analysis and relevant pharmacopoeial and regulatory requirements.
Lidocaine Hydrochloride should be stored in a tightly closed pharmaceutical-grade container under controlled conditions. It should be protected from excessive heat, moisture and direct light.
Specific storage and transportation conditions should follow the applicable manufacturer's approved specification.
Lidocaine Hydrochloride API may be supplied for qualified pharmaceutical manufacturing, formulation development, analytical and research applications, subject to applicable quality and regulatory requirements.
Lidocaine Hydrochloride API is available for qualified pharmaceutical development and manufacturing requirements subject to applicable quality and regulatory standards. Customers can request product specifications, Certificate of Analysis, analytical documentation, packaging information and commercial details according to their requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |