Tetracaine Hydrochloride is the hydrochloride salt of tetracaine and is a potent ester-type local anesthetic API. It is used in pharmaceutical formulations requiring local or regional anesthesia and belongs to the amino ester class of local anesthetic compounds.
Tetracaine Hydrochloride has the molecular formula C₁₅H₂₄N₂O₂·HCl and a molecular weight of 300.82 g/mol. Its CAS number is 136-47-0. USP describes the substance as tetracaine hydrochloride calculated on an anhydrous basis.
Tetracaine Hydrochloride, also known as amethocaine hydrochloride, is an ester-linked local anesthetic. The hydrochloride salt provides a water-soluble pharmaceutical form suitable for development of various dosage forms.
The API is generally characterized as a white to off-white crystalline powder. It is freely soluble in water and soluble in ethanol. Pharmacopoeial standards include identity, assay, related substances, loss on drying, pH and other quality-control requirements.
Tetracaine Hydrochloride is chemically designated as benzoic acid, 4-(butylamino)-, 2-(dimethylamino)ethyl ester, monohydrochloride. The molecule contains an aromatic para-butylamino group, an ester linkage and a dimethylaminoethyl side chain.
The hydrochloride salt differs from free-base tetracaine in molecular weight, physicochemical properties and pharmaceutical handling. Therefore, quality specifications should be applied specifically to Tetracaine Hydrochloride rather than the free base.
Tetracaine produces local anesthesia primarily by inhibiting voltage-gated sodium channels in neuronal membranes. This reduces sodium ion influx and prevents the initiation and propagation of nerve impulses.
The resulting reversible reduction in nerve conduction produces localized loss of sensation at the site of administration.
Tetracaine Hydrochloride is used as an active pharmaceutical ingredient in local anesthetic formulations.
Depending on the approved formulation and route of administration, tetracaine-containing products may be used for topical, ophthalmic or regional anesthetic applications.
USP recognizes Tetracaine Hydrochloride as an API used in pharmaceutical preparations, including ophthalmic and other local-anesthetic dosage forms.
Tetracaine Hydrochloride API quality is evaluated using pharmacopoeial and validated analytical procedures, including:
The current USP monograph defines Tetracaine Hydrochloride at 98.0–102.0% on anhydrous basis. USP also specifies related-substance controls and LOD NMT 0.5%.
Swapnroop Drugs and Pharmaceuticals is a WHO-GMP certified pharmaceutical company engaged in pharmaceutical APIs and pharmaceutical raw materials for domestic and international markets.
Tetracaine Hydrochloride API can be evaluated against applicable pharmacopoeial requirements, customer-specific specifications and regulatory requirements. Product quality parameters can be aligned with the requirements of the intended pharmaceutical application and destination market.
Tetracaine Hydrochloride should be protected from excessive light and moisture and stored in appropriately closed pharmaceutical containers.
USP specifies preservation in tight, light-resistant containers. The final storage conditions should follow the applicable product specification and stability data for the particular API batch.
Typical technical documentation for Tetracaine Hydrochloride API may include:
Swapnroop Drugs and Pharmaceuticals operates as a WHO-GMP certified pharmaceutical company with a portfolio of pharmaceutical APIs and pharmaceutical raw materials.
For Tetracaine Hydrochloride API requirements, customers can request product specifications, analytical documentation, packaging information and commercial details according to their pharmaceutical development, manufacturing and regulatory 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% |
| pH (1% Solution) | 4.5–6.0 |
| Individual Impurity | NMT 0.4% |
| Total Impurities | NMT 0.8% |
| Melting Point | Approximately 148°C |