BUPIVACAINE HYDROCHLORIDE
bupivacaine hydrochloride
CAS: 14252-80-3;18010-40-7
Molecular Formula: C18H28N2O.ClH
BUPIVACAINE HYDROCHLORIDE - Names and Identifiers
BUPIVACAINE HYDROCHLORIDE - Physico-chemical Properties
| Molecular Formula | C18H28N2O.ClH |
| Molar Mass | 324.89 |
| Melting Point | 249-2510C |
| Boling Point | 423.4°C at 760 mmHg |
| Flash Point | 209.9°C |
| Solubility | Soluble in water, freely soluble in alcohol. |
| Vapor Presure | 2.24E-07mmHg at 25°C |
| Appearance | Solid |
| Color | White to Off-White |
| Storage Condition | Refrigerator |
| Stability | Hygroscopic |
| Use | For surgical local anesthesia and postoperative analgesia |
BUPIVACAINE HYDROCHLORIDE - Risk and Safety
| Hazard Symbols | T+ - Very toxic |
| Risk Codes | 26/27/28 - Very toxic by inhalation, in contact with skin and if swallowed. |
| Safety Description | S22 - Do not breathe dust. S36/37/39 - Wear suitable protective clothing, gloves and eye/face protection. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) |
| UN IDs | UN 2811 6.1/PG 2 |
| WGK Germany | 3 |
| RTECS | TK6125000 |
| HS Code | 2933399090 |
| Hazard Class | 6.1(b) |
| Packing Group | III |
| Toxicity | LD50 in mice (mg/kg): 7.8 i.v., 82 s.c. (Henn, Brattsand) |
BUPIVACAINE HYDROCHLORIDE - Standard
Authoritative Data Verified Data
This product is 1-butyl-n-(2, 6-dimethylphenyl)-2-piperidinecarboxamide hydrochloride monohydrate. Calculated as dry product, containing no less than 98.5% of C18H28N20 • HCl.
Last Update：2024-01-02 23:10:35
BUPIVACAINE HYDROCHLORIDE - Trait
Authoritative Data Verified Data
- This product is white crystalline powder; Odorless = = =
- This product is soluble in ethanol, soluble in water, slightly soluble in chloroform, almost insoluble in ether.
Last Update：2022-01-01 14:21:21
BUPIVACAINE HYDROCHLORIDE - Differential diagnosis
Authoritative Data Verified Data
- take this product, precision weighing, according to the dry product calculation, plus O.Olmol/L hydrochloric acid solution is dissolved and quantitatively diluted to prepare a solution containing about 0401 mg per 1 ml, which is determined by UV-Vis spectrophotometry (general rule), there is a maximum absorption at the wavelength of 263nm and 271nm; The absorbance is 0.53~0.58 and 0.43~0.48 respectively.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 324).
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
Last Update：2022-01-01 14:21:21
BUPIVACAINE HYDROCHLORIDE - Exam
Authoritative Data Verified Data
acidity
take 0.10g of this product, Add 10ml of water to dissolve it, and determine it according to law (General rule 0631). The pH value should be 4.5~6.0.
clarity and color of solution
take this product l.Og, add water 50ml dissolved, the solution should be clear and colorless.
Related substances
take this product, add the mobile phase to dissolve and dilute to make a solution containing about 2mg per 1ml as the test solution; Take 1ml for precision measurement and put it in a 100ml measuring flask, dilute to the scale with the mobile phase, shake, and serve as a control solution. According to the test of high performance liquid chromatography (General rule 0512), silica gel bonded with eighteen alkyl silane was used as the filler; 0.05mol/L phosphate buffer solution (1.87g of potassium dihydrogen phosphate and g of sodium hydroxide were added with water to dissolve, the mobile phase was adjusted to pH 8.0-acetonitrile (35:65); The detection wavelength was 240nm. 20 u1 of control solution and 20 u1 of test solution were respectively injected into human liquid chromatograph, and the chromatogram was recorded to 3 times of the retention time of principal component peak. If there are impurity peaks in the chromatogram of the test solution, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%).
loss on drying
take this product, dry to constant weight at 105°C, weight loss should be 4.5% ~ 6.0% (General 0831).
ignition residue
take l.Og of this product and check it according to law (General rule 0841). The residue left shall not exceed 0.1%.
copper salt
take 0.25g of this product, Add 10ml of water to dissolve, add 0.05mol/L ethylenediamine tetraacetic acid disodium solution 0.25ml, shake, place for 2 minutes, add 0.20g of citric acid, ammonia Test Solution 1.0ml with diethyldithiocarbamate sodium test solution, shake well, add carbon tetrachloride 5ml shaking extraction 2 minutes; Carbon tetrachloride layer such as color, with the standard copper sulfate solution (each lml equivalent to 10ug of Cu)3.0ml, add water to 0.0003% ml shake, draw 10ml, compared with the control solution prepared by the same method, not deeper ().
Iron Salt
take the residue left under the item of ignition residue, add 2ml of hydrochloric acid, steam dry on a water bath, add 4ml of dilute hydrochloric acid, dissolve at a slight temperature, add 30ml of water and 50mg of ammonium persulfate, inspection according to law (General rule 0807), compared with the standard iron solution 0.001% ml with the same method of preparation of the control solution, not deeper ().
Last Update：2022-01-01 14:21:22
BUPIVACAINE HYDROCHLORIDE - Content determination
Authoritative Data Verified Data
take this product about 0.2g, precision weighing, add glacial acetic acid 20ml and acetic anhydride 20ml dissolved, according to the potential titration method (General rule 0701), with perchloric acid titration solution (O. 1 mol/L) titration, and the results of the titration were corrected with a blank test. Each 1 ml of perchloric acid titration solution (0.1 mol/ L) corresponds to 32.49mg of C18H2RN20-HCl.
Last Update：2022-01-01 14:21:23
BUPIVACAINE HYDROCHLORIDE - Category
Authoritative Data Verified Data
local anesthetic.
Last Update：2022-01-01 14:21:23
BUPIVACAINE HYDROCHLORIDE - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 14:21:23
BUPIVACAINE HYDROCHLORIDE - Bupivacaine Hydrochloride Injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of bupivacaine hydrochloride. Bupivacaine hydrochloride, based on C18H28N20 • HCl, shall be 90.0% to 110.0% of the labeled amount.
trait
This product is colorless or almost colorless clear liquid.
identification
(1) in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the control solution.
(2) take an appropriate amount of this product (about 25mg of bupivacaine hydrochloride), add 2ml of 13.5mol/L ammonia solution, shake, filter, and wash the precipitate with water, drying was performed under reduced pressure at 60 ° C. For 4 hours, followed by additional O.Olmol/L hydrochloric acid methanol solution 10ml, the precipitate was dissolved, placed on a water bath, stirred, evaporated, and the residue was dried at 105 C, the same results were shown in the identification (2) test under bupivacaine hydrochloride.
examination
- the pH value should be 4.0 to 6.5 (General 0631).
- Related Substances: dilute the product with mobile phase to prepare a solution containing about 2mg of bupivacaine hydrochloride per 1ml as a test solution; Take 1ml for precision measurement and put it in a 100ml measuring flask, dilute to the scale with the mobile phase, shake, and serve as a control solution. Determination of bupivacaine hydrochloride related substances according to the method. If there are impurity peaks in the chromatogram of the test solution, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%).
- bacterial endotoxin to take this product, can be used more than 0.06EU /ml of high sensitivity Limulus reagent, according to the law (General rule 1143), each 1 mg bupivacaine hydrochloride containing endotoxin should be less than 0.080EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler (pH adaptation range is greater than 8.0 ) ; 0.02mol/L phosphate buffer (potassium dihydrogen phosphate 2.72g and sodium hydroxide 0.75g), 8.0 ml of water was added to dissolve, and the pH value was adjusted to)-acetonitrile (35:65) was used as mobile phase; The detection wavelength was 240nm. The resolution of bupivacaine peak from adjacent impurity peak should meet the requirements.
- determination of precision quantity take appropriate amount of this product, diluted with mobile phase to make solution containing about 25ug per lml, as a sample solution, precision quantity of 20u1 injection liquid chromatograph, record chromatogram; another bupivacaine hydrochloride reference substance was determined by the same method. According to the external standard method to calculate the peak area, that is.
category
with bupivacaine hydrochloride.
specification
calculated by C18H28N20 • HC1 (l) 2ml:15mg(2)5ml:12.5mg (3)5ml:25mg (4)5ml:37.5mg
storage
light shielding, closed storage.
Last Update：2022-01-01 14:21:24
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Product Name: Bupivacaine hydrochloride Visit Supplier Webpage Request for quotationCAS: 14252-80-3
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