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Send EmailTetracaine Hydrochloride, Tetracaine Base, Tetracaine HC, 94-24-6, 136-47-0
TETRACAINE HYDROCHLORIDE
PRODUCT IDENTIFIER INFORMATION
| Parameter | Information |
|---|---|
| Product Name | Tetracaine Hydrochloride |
| Chemical Name (IUPAC) | 2-(Dimethylamino)ethyl 4-(butylamino)benzoate hydrochloride |
| CAS Number | 94-24-6 (HCl salt) / 136-47-0 (Base) |
| EC Number (EINECS) | 202-316-3 |
| Molecular Formula (Base) | C15H24N2O2 |
| Molecular Formula (HCl Salt) | C15H25ClN2O2 |
| Molecular Weight (Base) | 264.36 g/mol |
| Molecular Weight (HCl Salt) | 300.82 g/mol |
SECTION 1: CHEMICAL IDENTITY AND DESCRIPTION
| Parameter | Information |
|---|---|
| Chemical Name (IUPAC) | 2-(Dimethylamino)ethyl 4-(butylamino)benzoate hydrochloride |
| Systematic Name | 4-(Butylamino)benzoic Acid 2-(Dimethylamino)ethyl Ester Hydrochloride |
| Synonyms | Tetracaine Hydrochloride, Tetracaine HCl, Amethocaine, Pontocaine, Dicaine, Anethaine |
| Trade Names | Pontocaine, Ametop (topical gel), Tetravisc (ophthalmic) |
| CAS Number (HCl Salt) | 94-24-6 |
| CAS Number (Base) | 136-47-0 |
| EC Number (EINECS) | 202-316-3 |
| Molecular Formula (Base) | C15H24N2O2 |
| Molecular Formula (HCl Salt) | C15H25ClN2O2 |
| Molecular Weight (Base) | 264.36 g/mol |
| Molecular Weight (HCl Salt) | 300.82 g/mol |
| Chemical Class | Ester-type local anesthetic (para-aminobenzoic acid ester) |
| Physical State (20°C) | Solid (white crystalline powder) |
| Odor | Odorless |
| Taste | Bitter; temporary numbness on tongue |
SECTION 2: PHYSICAL AND CHEMICAL PROPERTIES
| Property | Value | Test Method |
|---|---|---|
| Appearance | White crystalline powder | Visual |
| Odor | Odorless | Olfactometric |
| Taste | Bitter; temporary numbness | Sensory |
| Molecular Weight (HCl Salt) | 300.82 g/mol | Calculated |
| Molecular Weight (Base) | 264.36 g/mol | Calculated |
| Melting Point (HCl Salt) | 147 – 150°C | DSC |
| Melting Point (Base) | 41 – 45°C | DSC |
| pKa (25°C) | ~8.5 | Potentiometric |
| Solubility in Water (HCl Salt) | Soluble (~100 g/L) | Gravimetric |
| Solubility in Ethanol | Soluble | General Method |
| Solubility in Chloroform | Soluble | General Method |
| Solubility in Ether | Slightly soluble | General Method |
| pH (1% HCl salt solution, 25°C) | 4.5 – 6.0 | pH Meter |
| Partition Coefficient (Log P) | ~3.73 (base) | Calculated |
| Protein Binding | ~75-85% | - |
| Stability | Stable under normal conditions; light-sensitive; hydrolyzes at alkaline pH |
SECTION 3: CHEMICAL PROPERTIES AND REACTIVITY
| Parameter | Information |
|---|---|
| Chemical Character | Ester-type local anesthetic; weak base (pKa ~8.5); highly lipophilic (Log P ~3.73) |
| Stability | Stable under normal conditions; light-sensitive |
| Hydrolysis | Hydrolyzed at alkaline pH and by plasma esterases → para-aminobenzoic acid (PABA) + dimethylaminoethanol |
| Decomposition Products (Heating) | CO, CO2, NOx, HCl |
| Incompatible Materials | Strong oxidizing agents, strong alkalis, silver nitrate, mercury salts |
| Reaction with Alkali | Free base precipitates; hydrolysis upon prolonged alkaline contact |
| Light Sensitivity | Slowly yellows upon exposure to light |
| Hazardous Polymerization | Does not occur |
SECTION 4: LOCAL ANESTHETICS COMPARISON
| Property | Tetracaine | Lidocaine | Procaine | Benzocaine | Bupivacaine |
|---|---|---|---|---|---|
| CAS Number | 94-24-6 | 137-58-6 | 59-46-1 | 94-09-7 | 38396-39-3 |
| Class | Ester | Amide | Ester | Ester | Amide |
| Onset of Action | Slow (5-10 min) | Fast (2-5 min) | Moderate (5-10 min) | Fast (topical) | Slow (5-10 min) |
| Duration of Action | Long (2-3 hrs) | Medium (1-2 hrs) | Short (30-60 min) | Short-Medium | Long (3-8 hrs) |
| pKa | 8.5 | 7.9 | 8.9 | 2.5 | 8.1 |
| Potency (Lidocaine=1) | ~4-8 | 1 | ~0.5 | 0.5 (topical) | ~4 |
| Maximum Dose | 1.5 mg/kg | 4.5 mg/kg | 10 mg/kg | Topical limited | 2 mg/kg |
| Allergy Risk | Moderate (PABA) | Very Low | Moderate (PABA) | Low | Very Low |
| Route | Topical, spinal | Injection, topical | Injection, topical | Topical only | Injection |
| Primary Use | Spinal, topical (ophthalmic, dermal) | Infiltration, topical | Infiltration (historical) | Topical (oral, dermal) | Epidural, spinal |
SECTION 5: PHARMACOLOGICAL PROPERTIES AND MECHANISM OF ACTION
| Property | Description |
|---|---|
| Mechanism of Action | Blocks voltage-gated sodium (Na+) channels; prevents action potential generation and conduction in nerve cells |
| Anesthetic Class | Ester-type local anesthetic (PABA ester) |
| Potency | 4-8 times more potent than lidocaine; 10 times more potent than procaine |
| Onset of Action | Slow (5-10 minutes); 10-20 minutes for topical application |
| Duration of Action | Long (2-3 hours) |
| Lipophilic Property | Highly lipophilic (Log P ~3.73); more lipophilic than lidocaine |
| Protein Binding | ~75-85% |
| Vasodilator Effect | Significant vasodilation; epinephrine added to slow absorption |
| Metabolism | Hydrolyzed by plasma pseudocholinesterases → PABA + dimethylaminoethanol |
| PABA Formation | Hydrolysis releases para-aminobenzoic acid (PABA); metabolite responsible for allergic reactions |
| Toxicity | More toxic than lidocaine and procaine; narrow safety margin |
| Systemic Toxicity | At high doses: convulsions, cardiac depression, hypotension, respiratory arrest |
SECTION 6: PRIMARY APPLICATION AREAS
| Sector / Application | Use | Typical Concentration |
|---|---|---|
| Ophthalmic | Corneal and conjunctival anesthesia (tonometry, foreign body removal, minor surgery) | 0.5 – 1% |
| Dermatological | Topical anesthetic cream, gel (laser, tattoo removal, minor surgery) | 1 – 2% (cream/gel) |
| ENT (Ear, Nose, Throat) | Nasal mucosa, laryngoscopy, bronchoscopy, endoscopy | 1 – 2% spray/solution |
| Spinal Anesthesia | Spinal (intrathecal) anesthesia | 0.5 – 1% (hyperbaric) |
| Dentistry | Topical mucosal anesthesia (pre-injection) | 1 – 2% solution/gel |
| Urology | Urethral anesthesia (catheterization, cystoscopy) | 0.5 – 1% solution |
| Proctology | Anorectal anesthesia (hemorrhoids, fissures) | 0.5 – 1% ointment |
| Emergency Medicine | Minor suturing, wound cleaning | 1 – 2% topical |
| Combination Products | Lidocaine + Tetracaine cream (EMLA-like effect) | 2.5% lidocaine + 2.5% tetracaine |
SECTION 7: QUALITY SPECIFICATIONS (PHARMACEUTICAL GRADE - USP/EP)
| Parameter | Specification | Test Method |
|---|---|---|
| Appearance | White crystalline powder | Visual |
| Odor | Odorless | Olfactometric |
| Purity (C15H25ClN2O2, Dry Basis) | 98.5 – 101.0% | HPLC / Titrimetric |
| Melting Range (HCl Salt) | 147 – 150°C | DSC / Capillary Tube |
| Loss on Drying (105°C, 2 hours) | ≤ 0.5% | Gravimetric |
| pH (1% solution, 25°C) | 4.5 – 6.0 | pH Meter |
| Chloride (Cl-) | 11.5 – 12.0% | Argentometric |
| Sulfated Ash | ≤ 0.1% | Gravimetric |
| Heavy Metals (as Pb) | ≤ 20 ppm | ICP-MS / USP <231> |
| Lead (Pb) | ≤ 3 ppm | ICP-MS |
| Arsenic (As) | ≤ 3 ppm | ICP-MS |
| Mercury (Hg) | ≤ 1 ppm | ICP-MS |
| Cadmium (Cd) | ≤ 1 ppm | ICP-MS |
| 4-(Butylamino)benzoic Acid (BABA) | ≤ 0.5% | HPLC |
| Related Substances (Total) | ≤ 1.0% | HPLC |
| Total Microbial Count | ≤ 100 CFU/g | USP <61> |
| Yeast and Mold | ≤ 10 CFU/g | USP <61> |
| E. coli | Negative in 1g | USP <62> |
| Salmonella spp. | Negative in 25g | USP <62> |
SECTION 8: TOXICOLOGICAL PROFILE
| Parameter | Value |
|---|---|
| Acute Oral Toxicity (LD50, Rat) | ~200-400 mg/kg |
| Acute Dermal Toxicity (LD50, Rabbit) | > 2,000 mg/kg |
| Skin Irritation | Mild irritant |
| Eye Irritation | Irritant |
| Respiratory Irritation | Inhalation of dust may cause mechanical irritation |
| Carcinogenicity | Not classified (IARC, NTP) |
| Mutagenicity | Negative in in vitro tests |
| Reproductive Toxicity | Fetal effects at high doses |
| Allergenicity | Moderate risk (PABA metabolite); cross-allergy risk |
| Systemic Toxicity | 4-8 times more toxic than lidocaine; convulsions, cardiac arrest, respiratory arrest at high doses |
| Potency | 4-8 times more potent than lidocaine; effective at lower doses but narrower safety margin |
SECTION 9: GHS CLASSIFICATION AND LABELING
GHS Classification (compliant with 1272/2008/EC):
| Hazard Class | Category | H-Statement |
|---|---|---|
| Acute Toxicity (Oral) | Category 3 | H301 |
| Acute Toxicity (Dermal) | Category 3 | H311 |
| Acute Toxicity (Inhalation) | Category 3 | H331 |
Signal Word: DANGER
Hazard Pictograms: GHS06 (Skull and Crossbones)
Hazard Statements (H-Codes):
| Code | Statement |
|---|---|
| H301 | Toxic if swallowed |
| H311 | Toxic in contact with skin |
| H331 | Toxic if inhaled |
Precautionary Statements (P-Codes):
| Code | Statement |
|---|---|
| P261 | Avoid breathing dust/fume/gas |
| P280 | Wear protective gloves/protective clothing/eye protection |
| P301+P310 | IF SWALLOWED: Immediately call a POISON CENTER/doctor |
| P302+P352 | IF ON SKIN: Wash with plenty of water and soap |
| P304+P340 | IF INHALED: Remove person to fresh air and keep comfortable for breathing |
| P311 | Call a POISON CENTER/doctor |
SECTION 10: FIRST AID MEASURES
| Exposure Route | Action to Take |
|---|---|
| Inhalation | Move to fresh air. Seek medical attention if breathing difficulty persists. |
| Skin Contact | Remove contaminated clothing immediately. Wash with plenty of water and soap for at least 15 minutes. Seek medical attention. |
| Eye Contact | Rinse immediately with plenty of water for at least 15 minutes. Remove contact lenses if present. Seek immediate medical attention. |
| Ingestion | Rinse mouth with water. Do NOT induce vomiting. Seek immediate medical attention and show container or label. |
SECTION 11: FIREFIGHTING MEASURES
| Parameter | Information |
|---|---|
| Fire Hazard | Non-flammable |
| Hazards During Fire | CO, CO2, NOx, HCl |
| Suitable Extinguishing Media | Water mist, CO2, dry chemical powder, foam |
| Special Protective Equipment | Self-contained breathing apparatus (SCBA), full protective clothing |
SECTION 12: STORAGE AND SHELF LIFE
| Parameter | Information |
|---|---|
| Storage Conditions | Cool (15-25°C), dry, well-ventilated area; light-protected closed packaging |
| Container Requirements | Tightly closed, light-resistant containers |
| Keep Away From | Light, moisture, alkaline substances, strong oxidizing agents |
| Shelf Life | 36 months (unopened original packaging under appropriate storage conditions) |
| Stability Note | Light-sensitive; hydrolyzes at alkaline pH; store in dry and dark environment |
SECTION 13: PACKAGING OPTIONS
| Packaging Type | Quantity | Material |
|---|---|---|
| Aluminum foil pouch (light-protective) | 1 kg | Laminated aluminum |
| Aluminum foil pouch (light-protective) | 5 kg | Laminated aluminum |
| Fiber drum with PE liner | 25 kg | Fiberboard + PE |
| HDPE drum (light-protected) | 25-50 kg | HDPE |
SECTION 14: TRANSPORTATION INFORMATION
| Parameter | Information |
|---|---|
| UN Number | UN 2811 (Toxic Solid, Organic, n.o.s.) |
| Hazard Class | 6.1 (Toxic Substances) |
| Packing Group | III |
| ADR/RID | UN 2811, Toxic Solid, 6.1, PG III |
| IMDG Code | UN 2811, Toxic Solid, 6.1, PG III |
| IATA (Air) | UN 2811, Toxic Solid, 6.1, PG III |
| Marine Pollutant | No |
| Transport Temperature | Ambient |
SECTION 15: REGULATORY STATUS
| Region / Authority | Status |
|---|---|
| USA (USP-NF) | Official monograph (USP Tetracaine Hydrochloride) |
| European Pharmacopoeia | Official monograph (Ph. Eur. Tetracaine Hydrochloride) |
| USA (FDA) | Prescription drug; OTC topical forms limited |
| WHO Essential Medicines List | Essential medicine (local anesthetic) |
| Turkey | Licensed pharmaceutical active ingredient; prescription drug |
SECTION 16: OTHER NAMES AND SYNONYMS
| Type | Name |
|---|---|
| Chemical Names | 2-(Dimethylamino)ethyl 4-(butylamino)benzoate hydrochloride; 4-(Butylamino)benzoic Acid 2-(Dimethylamino)ethyl Ester |
| Common Names | Tetracaine, Tetracaine HCl, Amethocaine, Pontocaine, Dicaine |
| Trade Names | Pontocaine, Ametop, Tetravisc |
| CAS Number (HCl Salt) | 94-24-6 |
| CAS Number (Base) | 136-47-0 |
| EC Number | 202-316-3 |
SECTION 17: SUMMARY TABLE
| Parameter | Value |
|---|---|
| Product | Tetracaine Hydrochloride |
| CAS Number | 94-24-6 |
| Molecular Formula (Base) | C15H24N2O2 |
| Molecular Weight (HCl Salt) | 300.82 g/mol |
| Appearance | White crystalline powder |
| Melting Point (HCl Salt) | 147 – 150°C |
| pKa | ~8.5 |
| Solubility in Water | ~100 g/L |
| Primary Function | Ester-type potent local anesthetic; spinal and topical use |
| Shelf Life | 36 months |
| GHS Signal Word | Danger |
| UN Number | UN 2811 (Toxic Solid, 6.1, PG III) |
SECTION 18: CRITICAL WARNINGS AND BEST PRACTICES
CRITICAL WARNINGS:
High Toxicity: 4-8 times more toxic than lidocaine; narrow safety margin. Strictly avoid overdose.
Maximum Dose: Maximum 1.5 mg/kg; approximately 1/3 that of lidocaine.
Topical Absorption: Rapidly absorbed from mucosa and damaged skin; calculate total dose when applying to large surfaces.
Light Sensitivity: Slowly yellows upon exposure to light; store in light-resistant containers.
Alkaline pH Hydrolysis: Hydrolyzes in alkaline environments; formulate at neutral or slightly acidic pH.
PABA Allergy: May cause allergic reactions in patients sensitive to PABA and ester-type anesthetics.
Injection Use: Not suitable for infiltration anesthesia due to high toxicity; for spinal and topical use only.
BEST PRACTICE RECOMMENDATIONS:
Dose Calculation: Calculate maximum safe dose (1.5 mg/kg); control total dose especially in topical applications.
Combination Products: Can be combined with lidocaine (EMLA-like) for faster onset and longer duration of action.
Ophthalmic Use: May cause epithelial toxicity on cornea; avoid prolonged use.
Storage: Store in dry, cool, and dark environment in tightly closed containers.
Alternative Selection: Amide-type anesthetics (lidocaine, bupivacaine) may be preferred for lower toxicity.
LEGAL DISCLAIMER:
The information provided in this document is presented in good faith based on our current knowledge and experience; however, since all usage conditions are beyond our control, it does not constitute a binding specification or warranty. This Technical Data Sheet is for informational purposes only and does not constitute medical advice. Users are obligated to test the suitability for their own applications. For complete safety, storage, handling, transportation, disposal, and regulatory compliance information, refer to the official Safety Data Sheet (SDS/MSDS) provided by the manufacturer/supplier. This product is not intended to diagnose, treat, cure, or prevent any disease.