Tetracaine Hydrochloride (CAS 136-47-0) – The Potent Ester-Type Local Anesthetic API

Tetracaine Hydrochloride (CAS 136-47-0) is the water-soluble hydrochloride salt form of Tetracaine, a powerful and long-acting amino ester local anesthetic. As the preferred form for most injectable and a wide range of topical applications, it is renowned for its profound anesthetic effect and extended duration of action. This API is a critical component in regional, spinal, and surface anesthesia, providing reliable and sustained blockade of sensory nerve impulses.

Manufactured in state-of-the-art facilities under strict current Good Manufacturing Practices (cGMP), our Tetracaine Hydrochloride is guaranteed to meet the highest standards of purity, potency, and consistency, ensuring both efficacy and patient safety in final pharmaceutical formulations.

Key Features & Advantages:

• Exceptional Potency & Prolonged Effect: Offers a significantly longer duration of anesthesia compared to many other local anesthetics (e.g., Lidocaine, Procaine), making it indispensable for lengthy surgical and obstetric procedures.

• High Water Solubility: The hydrochloride salt form provides excellent solubility in aqueous solutions, facilitating the preparation of sterile injectables, ophthalmic drops, and other water-based formulations.

• Rigorous Quality Control: Conforms to all major pharmacopeial monographs (USP, Ph. Eur., BP) for identity, assay, related substances, residual solvents, and other critical quality attributes.

• Proven Clinical Profile: Has a well-established history of safe and effective use in various anesthetic techniques, particularly in spinal anesthesia where its reliability is paramount.

• Comprehensive Documentation: Each batch is supported by a detailed Certificate of Analysis (CoA), providing full traceability and ensuring compliance for regulatory submissions.

Chemical Specifications:

• Chemical Name: 2-(Dimethylamino)ethyl 4-(butylamino)benzoate monohydrochloride

• Synonyms: Amethocaine Hydrochloride

• CAS Number: 136-47-0

• Molecular Formula: C₁₅H₂₄N₂O₂·HCl

• Molecular Weight: 300.83 g/mol

• Appearance: A fine, white or almost white, crystalline powder.

• Solubility: Freely soluble in water, soluble in ethanol, and very slightly soluble in chloroform or acetone.

• Melting Point: Approximately 148°C – 154°C (with decomposition).

• pKa: ~8.2 – 8.5

• Partition Coefficient: The hydrochloride salt has a lower measured logP than the freebase, contributing to its different formulation profile.

Mechanism of Action:

Tetracaine Hydrochloride exerts its local anesthetic effect by reversibly binding to specific voltage-gated sodium channels on the internal surface of neuronal cell membranes. This binding inhibits the transient influx of sodium ions (Na+) required for the depolarization phase of the action potential. The consequent blockade of ion conduction prevents the initiation and propagation of electrical impulses along nerve fibers, leading to a reversible loss of sensation (anesthesia) in a localized area. As an ester-type anesthetic, it is primarily metabolized by plasma pseudocholinesterase.

Applications & Intended Use:

This product is an Active Pharmaceutical Ingredient (API) intended exclusively for pharmaceutical manufacturing and research purposes.

Its primary applications include:

• Spinal Anesthesia: The gold-standard application. Formulated into isobaric or hyperbaric solutions for subarachnoid (spinal) block, providing anesthesia for lower abdominal, pelvic, perineal, and lower limb surgeries.

• Topical Anesthesia: Used in the manufacture of ophthalmic solutions (eye drops), creams, ointments, and gels to anesthetize mucous membranes of the eyes, nose, throat, and respiratory tract.

• Peripheral Nerve Block: Although less common than other agents due to its potency and duration, it is used in specific regional nerve block techniques.

• Dental Anesthetics: Employed in certain specialized dental formulations for prolonged procedures.

• Pharmaceutical Research & Development: Utilized in preclinical studies, analytical method development (as a reference standard), and the creation of novel drug delivery systems.

Packaging & Storage:

To ensure maximum stability and protect its integrity, Tetracaine Hydrochloride is packaged in:

• Primary Packaging: Double polyethylene bags with desiccant to control moisture.

• Secondary Packaging: Sealed, light-resistant fiber drums or HDPE containers.

• Custom Options: Available in amber glass bottles for smaller R&D quantities.

• Standard Sizes: Offered in a range of quantities from 25 grams to 25 kilograms to suit both laboratory and industrial-scale manufacturing needs.

Storage Conditions: Store in a cool, dry, well-ventilated place. Keep the container tightly closed and protected from light. Store at controlled room temperature (15-30°C) or as specified on the Certificate of Analysis.

Quality & Compliance:

Our Tetracaine Hydrochloride is produced under a comprehensive Quality Management System. Every batch is rigorously tested, and the accompanying Certificate of Analysis (CoA) provides full analytical traceability, ensuring the product meets the stringent requirements of global regulatory authorities (FDA, EMA, etc.).