Tetracaine hydrochloride CAS No: 136-47-0
Tetracaine hydrochloride ,136-47-0, Tetracaine hydrochloride CAS No: 136-47-0
Content
Product Introduction
Product name: Tetracaine hydrochloride
Product purity: ≥ 99%
CAS No ：136-47-0
Product appearance: white crystalline powder
Product packaging: aluminum foil bag/cardboard drum
Product storage: Store in a dry and cool place, avoiding sunlight and high temperature
Molecular formula: C15H25ClN2O2
Molecular weight: 300.82
EINECS No：205-248-5
Shelf life：24 months
Product Description
Shaanxi Sunrise Pharmaceutical Co., Ltd. supplies pharmaceutical-grade Tetracaine Hydrochloride (CAS 136-47-0), a long-acting ester local anesthetic with a purity of ≥99%, fully compliant with USP/EP pharmacopoeial standards. This product presents as white crystalline powder, slightly hygroscopic, freely soluble in water and ethanol, and chemically stable under proper storage conditions (sealed, cool, and dry environment).
With a molecular formula of C₁₅H₂₅ClN₂O₂ and molecular weight of 300.82, it exerts anesthetic effects by blocking voltage-sensitive sodium ion channels in nerve membranes, thereby inhibiting nerve impulse conduction to achieve reversible sensory loss. Our Tetracaine Hydrochloride is manufactured in GMP-certified facilities, featuring strict raw material screening and full-process quality control. Each batch undergoes rigorous HPLC and UV-Vis detection to ensure minimal impurities, stable chemical properties, and reliable efficacy for pharmaceutical formulations.
Product Advantages
1. Superior Purity & Quality Compliance: Purity ≥99%, total impurities ≤0.5%, heavy metals ≤10ppm, fully complying with USP/EP standards. Advanced detection technologies (HPLC, GC) ensure batch-to-batch consistency, minimizing potential safety risks caused by impurities.
2. Optimized Synthesis Process: Adopting an improved three-step synthesis process with self-developed high-efficiency catalysts (SO₄²⁻/ZrO₂-Al₂O₃, Pd/BP-COF), the overall yield exceeds 97%, while effectively controlling butyraldehyde impurities. The catalysts are reusable multiple times, reducing production costs and environmental footprint.
3. Comprehensive Quality Traceability: A full-chain traceability system is established from raw material procurement to finished product delivery. Each batch is accompanied by a detailed Certificate of Analysis (COA), supporting third-party re-inspection to meet global pharmaceutical regulatory requirements (e.g., FDA, EMA).
4. Flexible Supply & Customization: Supports bulk supply (1kg/bag, 25kg/drum) with light-resistant and moisture-proof packaging. Provides customized processing services according to customer needs for formulation development, and offers professional technical support for application scenarios.
5. GMP-Certified Production System: Produced in GMP-compliant facilities with strict control over production environment (Class D cleanroom), equipment sterilization, and personnel operations. The facility has passed multiple international audits, ensuring product quality meets market access requirements worldwide.
Product COA
| Test Item | Specification | Result | Detection Method |
|---|---|---|---|
| Appearance | White crystalline powder, slightly hygroscopic | Conforms | Visual Inspection |
| Identification (A) | Conforms to standard IR spectrum | Conforms | IR Spectroscopy (USP Method) |
| Identification (B) | Melting point: 130-132℃ | 131℃ | Melting Point Determination (USP Method) |
| Identification (C) | Positive for chloride ions | Conforms | Chemical Reaction (USP Method) |
| Appearance of Solution | Clear and colorless (2% m/v in water) | Conforms | Visual Inspection |
| pH Value | 4.5-6.5 (1% m/v in water) | 4.8 | pH Meter (Precision ±0.01) |
| Related Substances | Impurity A ≤0.05%; Impurity B ≤0.1%; Impurity C ≤0.1%; Unspecified impurities ≤0.1%; Total impurities ≤0.5% | Impurity A<0.05%; Impurity B <0.05%; Impurity C <0.1%; Unspecified impurities <0.1%; Total impurities <0.5% | HPLC (USP Method, Column: C18) |
| Heavy Metals | ≤10 ppm | Conforms (≤5 ppm) | Atomic Absorption Spectroscopy |
| Loss on Drying | ≤1.0% (105℃, 2h) | 0.5% | Thermogravimetric Analysis |
| Sulphated Ash | ≤0.1% | 0.06% | Ignition Method (800±25℃) |
| Residual Solvents | Meets ICH Q3C(R7) requirements | Conforms | GC (Headspace Sampling) |
| Assay (Tetracaine Hydrochloride) | 99.0-101.0% (on dried basis) | 100.0% | HPLC (External Standard Method) |
| Conclusion: The product complies with USP47-NF42/EP10.0 standards and Shaanxi Sunrise Pharmaceutical internal quality specifications. | |||
Note: This COA is for reference only. Each batch of products will be accompanied by a formal COA with batch number, production date, expiration date, and signature of the quality inspector.
Product Function
Pharmacological Function
As a long-acting ester local anesthetic, Tetracaine Hydrochloride exerts its effect by blocking voltage-sensitive sodium ion channels on the nerve membrane, inhibiting sodium ion influx and thereby preventing the generation and conduction of nerve action potentials. This induces reversible loss of sensory function in the anesthetized area, with minimal impact on motor nerves at conventional clinical doses.
Its lipophilicity is higher than that of procaine, enabling slow diffusion in tissues and a longer anesthetic duration (2-3 times that of procaine). The pKa value is approximately 8.1, existing mainly in cationic form under physiological pH conditions, which is conducive to binding to nerve membrane receptors and enhancing anesthetic efficacy.
Safety & Pharmacokinetics
After local administration, it is slowly absorbed through mucous membranes or skin, resulting in low systemic bioavailability. It is metabolized by plasma cholinesterase into inactive metabolites, which are primarily excreted via the kidneys. No obvious accumulation occurs in the body when used in accordance with clinical guidelines.
Product Application
Tetracaine Hydrochloride is widely used in pharmaceutical formulations and clinical scenarios due to its strong anesthetic effect and long duration, mainly including the following fields:
1. Ophthalmology: Used as a 1% isotonic solution for surface anesthesia in ophthalmic examinations (e.g., corneal foreign body removal, intraocular pressure measurement) and minor surgeries, relieving pain during operation without affecting visual acuity.
2. Otolaryngology: A 1-2% solution is used for surface anesthesia of the pharynx, trachea, and esophagus prior to endoscopy (e.g., laryngoscopy, bronchoscopy) to reduce reflex reactions and improve procedural safety.
3. Anesthesiology: Used for spinal anesthesia, epidural block, and nerve conduction block in surgical procedures, often mixed with epinephrine to slow absorption and prolong anesthetic duration. The recommended dosage is strictly controlled according to the anesthesia method (maximum dose ≤80mg for epidural block).
4. Dermatology & Dentistry: 0.5-1% ointment or cream is used for surface anesthesia in skin diseases (e.g., neurodermatitis) and dental procedures (e.g., tooth extraction, periodontal treatment) to relieve local pain.
5. Gynecology & Urology: Used as a gel or jelly for local lubrication and anesthesia during intubation, endoscopy, or minor surgeries (e.g., abortion, cystoscopy), reducing tissue irritation and patient discomfort.
Production Packaging
Payment Methods
Delivery methods
Products FAQ
1. Does your Tetracaine Hydrochloride comply with international pharmacopoeial standards?
Our product fully complies with USP47-NF42, EP10.0, and CP2020 standards. Each batch achieves a purity of ≥99%, with total impurities ≤0.5% and heavy metals ≤5ppm, verified by rigorous HPLC and GC detection. We provide a formal Certificate of Analysis (COA) for each batch, supporting third-party re-inspection to meet regulatory requirements of different countries.
2. What is the minimum order quantity (MOQ) and delivery cycle?
The MOQ is 1kg, and we support bulk supply (1kg/bag, 25kg/drum). For stock products, the delivery cycle is 3-5 working days; for customized or large-batch orders (≥100kg), it is 7-15 working days depending on production scheduling. We cooperate with well-known international logistics companies such as DHL, FedEx and TNT to ensure timely global delivery.
3. What are the main application fields of Tetracaine Hydrochloride and its formulation requirements?
It is widely used in ophthalmology, otolaryngology, anesthesiology, dermatology, gynecology and urology. For ophthalmology, it is formulated into a 1% isotonic solution for surface anesthesia; for otolaryngology, a 1-2% solution is used for pre-endoscopy anesthesia; for dermatology and dentistry, 0.5-1% ointment/cream is applied. We provide professional technical support on solubility parameters, excipient compatibility and formulation optimization.
4. What are the storage conditions and shelf life of Tetracaine Hydrochloride?
It should be stored in a sealed, cool, dry and light-proof warehouse, with the temperature controlled at 2-8℃ and relative humidity ≤60%, away from oxidants and acidic substances. Under proper storage conditions, the shelf life is 24 months from the production date. After opening, use it within 30 days and keep it tightly sealed to avoid moisture absorption and contamination.
5. Do you provide customized processing services and after-sales support?
We offer customized services including particle size adjustment (100-500 mesh), solubility modification and special purity requirements (≥99.5%), as well as small-batch trial production to meet R&D needs. For quality issues caused by production within the shelf life (verified by third-party testing), we provide replacement, refund or compensation, with our technical team responding within 24 hours.