136-47-0
tetracaine hydrochloride
CAS: 136-47-0
Molecular Formula: C15H25ClN2O2
136-47-0 - Names and Identifiers
136-47-0 - Physico-chemical Properties
| Molecular Formula | C15H25ClN2O2 |
| Molar Mass | 300.82 |
| Density | 1.1279 (rough estimate) |
| Melting Point | 149°C |
| Boling Point | 389.4°C at 760 mmHg |
| Flash Point | 189.3°C |
| Water Solubility | Soluble in water at 50mg/ml |
| Solubility | alcohol: solublesoluble 40 parts of solvent |
| Vapor Presure | 2.87E-06mmHg at 25°C |
| Appearance | neat |
| Color | White to Almost white |
| Merck | 14,9188 |
| pKa | 8.39(at 25℃) |
| Storage Condition | 2-8°C |
| Refractive Index | 1.5200 (estimate) |
| Use | Used as a local anesthetic |
136-47-0 - Risk and Safety
| Hazard Symbols | T - Toxic |
| Risk Codes | R25 - Toxic if swallowed R36 - Irritating to the eyes R43 - May cause sensitization by skin contact R42/43 - May cause sensitization by inhalation and skin contact. |
| Safety Description | S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S36/37 - Wear suitable protective clothing and gloves. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) S36/37/39 - Wear suitable protective clothing, gloves and eye/face protection. S22 - Do not breathe dust. S53 - Avoid exposure - obtain special instructions before use. |
| UN IDs | 2811 |
| WGK Germany | 3 |
| RTECS | DG4900000 |
| HS Code | 29224999 |
| Hazard Class | 6.1 |
| Packing Group | III |
| Toxicity | LD50 i.p. in mice: 70 mg/kg (Dawes); also reported as LD50 in female mice (mg/kg): 13 i.v.; 35 s.c. (Bopp) |
136-47-0 - Standard
Authoritative Data Verified Data
This product is 4-(butylamino) benzoic acid -2-(dimethylamino) ethyl ester hydrochloride. The content of C15H24N202 • HCl shall not be less than 99.0% calculated on a dry basis.
Last Update：2024-01-02 23:10:35
136-47-0 - Trait
Authoritative Data Verified Data
- This product is white crystal or crystalline powder; Odorless.
- This product is soluble in water, soluble in ethanol, insoluble in ether.
melting point
The melting point of this product (General rule 0612 first method) is 147~150°C.
Last Update：2022-01-01 14:20:00
136-47-0 - Differential diagnosis
Authoritative Data Verified Data
- take about 0.lg of this product, Add 10ml of 5% sodium acetate solution, add 1ml of 25% ammonium thiocyanate solution to precipitate white crystals; Filter, wash with water for crystallization, and dry at 80°C, the melting point is about 0612°C as determined by law (General Rule 131, first method).
- take about 40mg of this product, add 2ml of water to dissolve, and add 3ml of nitric acid to show yellow color.
- The infrared absorption spectrum of this product should be consistent with that of the reference product (General rule 0402).
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
Last Update：2022-01-01 14:20:01
136-47-0 - Exam
Authoritative Data Verified Data
acidity
take this product, add water to dissolve and dilute the solution containing about 10 mg per lml, and determine it according to law (General 0631). The pH value should be 4.5~6.5.
clarity and color of solution
take l.Og of this product, Add 10ml of water to dissolve, the solution should be clear and colorless; If it is turbid, it should not be more concentrated compared with No. 1 turbidity standard solution (General rule 0902 first method).
Related substances
take this product, precision weighing, adding water to dissolve and quantitatively dilute to make a solution containing 50mg per lml, as a test solution; Take the other butyl amino benzoic acid reference, precision weighing, methanol was added to dissolve and quantitatively diluted to prepare 0.10 mg solution, as a control solution. According to the thin layer chromatography (General 0502) test, absorb the above two solutions each 5 u1, respectively, on the same silica gel GF 254 thin layer plate, with chloroform-methanol-isopropylamine (98:7:2) for the development of the agent, expand, dry, set the UV light (254nm) under the inspection. If the test solution shows impurity spots, the color should not be deeper compared with the main spots of the reference solution.
easily carbonized
take 0.50g of this product and check it according to law (General rule 0842). Compared with the orange-yellow 3 Standard Colorimetric solution (General rule 0901, first method), it shall not be deeper.
loss on drying
take this product, dry to constant weight at 105°C, weight loss shall not exceed 1.0% (General rule 0831).
ignition residue
l.Og of this product shall be taken for inspection according to law (General rule 0841), and the residual Tongtong shall not exceed 0.1%.
Heavy metals
The residue left under the item of taking the ignition residue shall not contain more than 10 parts per million of heavy metal when examined by law (General Principles 0821, Law II).
Last Update：2022-01-01 14:20:01
136-47-0 - Content determination
Authoritative Data Verified Data
take about 0.25g of this product, weigh precisely, add 50ml of ethanol, shake to dissolve, add 5ml of 0.01md/L hydrochloric acid solution, shake well, potentiometric titration (General 0701), with sodium hydroxide titration solution (0.1 mol/L) titration, the difference between the two burst point volumes as The titration volume. Each 1 ml of sodium hydroxide titration solution (0.1 mol/L) corresponds to 30.08mg of C15H24N202. Hc1.
Last Update：2022-01-01 14:20:02
136-47-0 - Category
Authoritative Data Verified Data
local anesthetic.
Last Update：2022-01-01 14:20:02
136-47-0 - Storage
Authoritative Data Verified Data
sealed storage.
Last Update：2022-01-01 14:20:02
136-47-0 - Tetracaine Hydrochloride for Injection
Authoritative Data Verified Data
This product is a sterile freeze-dried product of tetracaine hydrochloride. Tetracaine hydrochloride (C15H24N202 • HC1) shall be present at 93.0% to 107.0% of the label load.
trait
This product is a white loose mass or powder.
identification
- take 1 bottle of this product, add 2ml of water to dissolve, add 3ml of nitric acid, and the solution shows yellow.
- the solution under the content measurement was measured by ultraviolet-visible spectrophotometry (General 0401), and the maximum absorption was found at a wavelength of NM and Nm.
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
examination
- the color of the solution to take this product 1 bottle, add water 5ml to dissolve, the solution should be colorless.
- acidity the pH value of the solution under the color of the solution is measured according to the law (General 0631), and the pH value should be 5.0 to 6.0. Relevant substances take this product, precision weighing, plus three gas methane dissolved and quantitative dilution made of tetracaine hydrochloride solution containing 50mg per lml, as the test solution
- solution; A control sample of p-butylaminobenzoic acid was weighed precisely, dissolved with methanol and quantitatively diluted to prepare a solution containing 0.20RNG per 1 ml, which was used as a control solution. According to the thin layer chromatography (General 0502) test, absorb the above two solutions each 5 u1, respectively, on the same silica gel GF254 thin layer plate, with chloroform-methanol-isopropylamine (98:7:2) for development, open, dry, set under UV light (254mn) to view. If the test solution shows impurity spots, the color should not be deeper compared with the main spots of the reference solution.
- the moisture content of this product shall not exceed 0832 as determined by the method for determination of moisture (General rule 3.0%, first method 1). The content uniformity of
- shall be calculated based on the content of each bottle measured under the content determination item, and shall comply with the regulations (General rule 0941).
- bacterial endotoxin this product, according to the law (General 1143), each 1 mg of tetracaine hydrochloride containing endotoxin should be less than 0.70EU; For intrathecal injection should be less than 0.15EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
Take 10 bottles of this product, add water to dissolve, and quantitatively transfer to 250ml measuring flask, dilute with water to scale, shake, as a test solution; Take tetracaine hydrochloride control, precision weighing, dissolved in water and quantitative dilution to make a solution containing about 0.2mg per 1 ml, as a reference solution. Take 3ml of test solution and 3ml of reference solution respectively, put them into l-200 measuring flask, and add 5ml of hydrochloric acid solution () and phosphate buffer solution (pH 6.0). (Take 20g of Dipotassium hydrogen phosphate and 80g of potassium dihydrogen phosphate, add water to dissolve and dilute to 1000ml, adjust the pH value to 6.0 with 6mol/L phosphoric acid solution or 10 mol/L potassium hydroxide solution) 10ml, dilute to the scale with water, shake well, according to UV-visible spectrophotometry (General rule 0401), the absorbance was measured at the wavelength of 310mn, the content of each bottle was calculated, and the average content was obtained.
category
Same as tetracaine hydrochloride.
specification
50mg
storage
light shielding, closed storage.
Last Update：2022-01-01 14:20:03
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CAS: 136-47-0
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