Lidocaine Hydrochloride, also known as Lidocaine HCl or Lignocaine Hydrochloride, is the hydrochloride salt of lidocaine and a widely used amide-type local anesthetic. It produces reversible blockade of nerve conduction and is used in pharmaceutical formulations for local and regional anesthesia. Lidocaine also has Class IB antiarrhythmic activity when administered systemically.
Lidocaine HCl works primarily by blocking voltage-gated sodium channels in nerve membranes. This reduces sodium-ion influx and prevents the initiation and propagation of action potentials, resulting in reversible loss of sensation.
Lidocaine HCl is an established local anesthetic pharmaceutical API manufactured through controlled chemical synthesis, purification, hydrochloride salt formation and crystallization.
Important quality attributes include identity, assay, related substances, water content, pH, heavy metals, sulfated ash and residual solvents.
CAS Number: 6108-05-0
Alternate / Anhydrous CAS: 73-78-9
Molecular Formula: C14H22N2O·HCl·H2O
Molecular Weight: 288.81 g/mol
Anhydrous Molecular Weight: 270.80 g/mol
Chemical Name: 2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide hydrochloride monohydrate
Synonyms: Lidocaine Hydrochloride, Lidocaine HCl, Lignocaine Hydrochloride, Xylocaine Hydrochloride
Drug Class: Local Anesthetic
Pharmacological Class: Amide Local Anesthetic / Class IB Antiarrhythmic
Therapeutic Area: Anesthesiology / Pain Management / Cardiology
Lidocaine HCl blocks voltage-gated sodium channels in neuronal membranes. By reducing sodium permeability, it inhibits the generation and propagation of action potentials along nerves and produces reversible local anesthesia.
Lidocaine HCl is used in pharmaceutical formulations for:
Lidocaine hydrochloride injection is used for infiltration and nerve-block procedures, while intravenous formulations are also used as antiarrhythmic therapy.
Lidocaine Hydrochloride Monohydrate is a white or almost white crystalline powder, very soluble in water and freely soluble in ethanol. Published EP-grade specifications describe a melting point of 74–79°C for the monohydrate.
A controlled Lidocaine HCl API manufacturing process may include:
Typical Lidocaine HCl API testing includes:
Store Lidocaine HCl in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light. Final storage requirements should follow the approved API specification and validated stability data.
Lidocaine HCl is relevant to research involving:
| 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 0.1% |
| pH (1% Solution) | 4.0 – 5.5 |
| Individual Impurity | NMT 0.10% |
| Total Impurities | NMT 5.0% |
| Water Content | 5.5% – 7.0% |