Swapnroop Drugs & Pharmaceuticals is a pharmaceutical API manufacturer and supplier of Tocainide Hydrochloride API in India for pharmaceutical formulation, generic drug manufacturing, bulk API procurement and export requirements.
Tocainide Hydrochloride is the hydrochloride salt of tocainide, a Class IB antiarrhythmic agent and structural analogue of lidocaine. It acts primarily by blocking voltage-gated sodium channels, reducing abnormal electrical activity and excitability in cardiac tissue.
Tocainide Hydrochloride is identified by CAS 71395-14-7, with the molecular formula C₁₁H₁₆N₂O·HCl and molecular weight 228.72 g/mol. FDA's substance registry confirms the hydrochloride salt structure, racemic stereochemistry and molecular weight.
Tocainide Hydrochloride belongs to the Class IB antiarrhythmic category. It is the monohydrochloride salt of racemic tocainide and has historically been marketed as an oral antiarrhythmic drug. The substance is currently classified by NCATS as previously marketed in the United States.
The API is described as a solid/crystalline material. Published chemical references describe Tocainide Hydrochloride as white to off-white and soluble in water to varying degrees depending on the reference and test conditions.
| Parameter | Details |
|---|---|
| Product Name | Tocainide Hydrochloride |
| CAS Number | 71395-14-7 |
| Alternate/Deprecated CAS | 35891-93-1 |
| Parent API | Tocainide |
| Parent CAS | 41708-72-9 |
| Molecular Formula | C₁₁H₁₆N₂O·HCl |
| Molecular Weight | 228.72 g/mol |
| Chemical Name | 2-Amino-N-(2,6-dimethylphenyl)propanamide monohydrochloride |
| API Category | Antiarrhythmic API |
| Pharmacological Class | Class IB Antiarrhythmic |
| Stereochemistry | Racemic |
| Physical Form | Solid / crystalline material |
The current PubChem and FDA GSRS records support CAS 71395-14-7, molecular formula and molecular weight. The FDA record identifies the substance as racemic.
Tocainide Hydrochloride produces antiarrhythmic activity through reversible blockade of voltage-gated sodium channels. This decreases the inward sodium current responsible for rapid depolarization and conduction in excitable cardiac tissue, helping reduce abnormal myocardial excitability.
Tocainide Hydrochloride has been used as an oral antiarrhythmic API for the management of certain ventricular arrhythmias.
Its pharmaceutical relevance includes:
Because Tocainide Hydrochloride is a previously marketed active ingredient in the United States, current commercial and regulatory use should be evaluated according to the target market and applicable regulations.
Swapnroop Drugs & Pharmaceuticals supplies Tocainide Hydrochloride API for pharmaceutical companies requiring antiarrhythmic active pharmaceutical ingredients.
As a Tocainide Hydrochloride API supplier in India, Swapnroop can support bulk procurement, pharmaceutical formulation development, generic manufacturing and export-oriented API requirements, subject to applicable product specifications and regulatory requirements.
Tocainide Hydrochloride API can be supplied for:
The USP monograph historically specified 98.0–101.0% Tocainide Hydrochloride on the dried basis. It also specified loss on drying NMT 0.5%, residue on ignition NMT 0.1%, heavy metals NMT 0.002% (20 ppm), an individual secondary chromatographic spot NMT 0.5%, and total secondary spots NMT 1.0%.
Importantly, USP's current index shows Tocainide Hydrochloride as deleted, so the historical USP values should not be represented as a current active USP release specification.
The historical USP monograph specifies preservation in well-closed containers.
Storage and packaging should be determined according to the applicable current specification, stability data and customer requirements. Moisture protection should be maintained during storage and transportation.
Depending on the supply requirement, documentation may include:
Tocainide Hydrochloride is a well-characterized racemic Class IB antiarrhythmic active ingredient. Swapnroop Drugs & Pharmaceuticals supports pharmaceutical companies seeking Tocainide Hydrochloride API in India for development, procurement and applicable pharmaceutical manufacturing requirements.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 20 ppm |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Melting Point | Approx. 244–251°C |