Esomeprazole
Esomeprazole
CAS: 119141-88-7
Molecular Formula: C17H19N3O3S
Esomeprazole - Names and Identifiers
Esomeprazole - Physico-chemical Properties
| Molecular Formula | C17H19N3O3S |
| Molar Mass | 345.42 |
| Density | 1.37±0.1 g/cm3(Predicted) |
| Boling Point | 600.0±60.0 °C(Predicted) |
| Specific Rotation(α) | D20 -155° (c = 0.5 in chloroform) |
| Flash Point | 316.663°C |
| Vapor Presure | 0mmHg at 25°C |
| pKa | 8.50±0.10(Predicted) |
| Storage Condition | Sealed in dry,Room Temperature |
| Refractive Index | 1.669 |
| Physical and Chemical Properties | Esomeprazole (Esomeprazole) (S)? Omeprazole, molecular weight 345.41600, density 1.37g/cm3, boiling point 600°C at 760mmHg, flash point 316.7°C, refractive index 1.669, vapor pressure 0mmHg at 25°C, A white or off-white lyophilized cake or powder. It can effectively inhibit gastric acid secretion and is often used in the treatment of diseases associated with gastric acid secretion disorder. |
Esomeprazole - Risk and Safety
| HS Code | 29339900 |
Esomeprazole - Preparation Method
Open Data Verified Data
obtained from omeprazole resolution.
Last Update：2024-01-02 23:10:35
Esomeprazole - Application
Open Data Verified Data
AstraZeneca pharmaceutical company, UK, was first launched in the UK in September 2000. Proton pump inhibitors. The pure levorotatory isomer of Omeprazole. For the initial and long-term treatment of gastroesophageal reflux disease (GORD), including erosive reflux esophagitis (including erosive esophagitis), can be used for long-term maintenance treatment of esophagitis and prevention of GORD recurrence, and symptomatic treatment of GORD's disease. Eradication of Helicobacter pylori in combination with antibiotics, treatment of duodenal ulcer caused by Helicobacter pylori, and prevention of recurrence of peptic ulcer associated with Helicobacter pylori.
Last Update：2025-08-19 16:24:40
Esomeprazole - Standard
Authoritative Data Verified Data
This product is 5-methoxy-2-[(S)-[(4-methoxy-3, 5-dimethyl-2-pyridyl) methyl] thionyl]-1H-benzimidazole sodium salt. Based on water and solvent-free, containing not less than 98.0%.
Last Update：2024-01-02 23:10:35
Esomeprazole - Trait
Authoritative Data Verified Data
- This product is white or off-white powder; There is moisture.
- This product is soluble in ethanol.
Last Update：2022-01-01 11:34:41
Esomeprazole - Differential diagnosis
Authoritative Data Verified Data
- The infrared absorption spectrum of this product should be consistent with that of the reference product (General rule 0402).
- take about 195mg of this product, weigh it accurately, put it in a 200ml measuring flask, add water to dissolve and dilute it to the scale, shake it, take 10ml accurately, put it in a 100ml measuring flask, add 3.8% potassium chloride solution 10ml, dilute to the scale with water, shake well, as a test solution; Another precision take standard sodium solution (each lml is equivalent to l.O mg of Na)lmh in a 25ml measuring flask, diluted with water to the scale, shake well, take 15ml, put in a 3.8% ml measuring flask, Add 10ml of potassium chloride solution, dilute with water to the scale, shake well as a control solution. Take the control solution and the test solution, according to Atomic Absorption Spectrophotometry (General 0406), in 589. At the wavelength of Onm, the absorbance of the test solution should be basically consistent with the absorbance of the reference solution.
Last Update：2022-01-01 11:34:42
Esomeprazole - Exam
Authoritative Data Verified Data
absorbance of impurities
take this product 2.0g, add methanol 100ml to dissolve, immediately according to UV-visible spectrophotometry (General rule 0401), at 440nm and 650nm Wavelength determination, the absorbance shall not be greater than 0.05.
alkalinity
take 2.0g of this product, add 100mn of water to dissolve it, and measure it according to law (General rule 0631). The pH value should be 10.3~11.3.
Related substances
take an appropriate amount of this product, precision weighing, and add mobile phase A to dissolve and quantitatively dilute to make A solution containing about 0.2mg per 1 ml, as A test solution (using A new precision quantity to take appropriate amount, diluted with mobile phase A to make A solution containing about 0.2ug per 1 ml, as A sensitivity solution. Silica gel bonded with eighteen alkyl Silanes (Microspher C18, 0512mm x mm , 3um or performance equivalent column) was used as the filler according to the determination by high performance liquid chromatography (general rule); the mobile phase A was water-phosphate buffer (pH 7.6) (containing 0.0052mol of sodium dihydrogen phosphate and 0.032mol of sodium dihydrogen phosphate per 1000ml)-acetonitrile (80:10:10); using acetonitrile-phosphate buffer (pH 7.6)-Water (80:1:19) as mobile Phase B, the detection wavelength was 302mn, and the linear gradient elution was carried out as follows. Take appropriate amount of omeprazole reference substance and impurity I reference substance respectively, add mobile phase A to dissolve and dilute to make A mixed solution containing about 0.02 mg per 1 ml, and inject 20u1 into human liquid chromatograph, the retention time of the omeprazole peak is 14-19 minutes, and the degree of separation of the omeprazole peak from the impurity I peak should be greater than 2.5. The sensitivity solution 20u1 was injected into the liquid chromatograph, and the chromatogram was recorded. The signal to noise ratio of the main component peak height should be greater than 10. Then, 200 of the sample solution was accurately measured and injected into the liquid chromatograph, and the chromatogram was recorded for 30 minutes. If there are impurity peaks in the chromatogram of the test solution, according to the peak area normalization method, impurity I shall not exceed 0.2%, impurity II (relative retention time is about 0.21) and impurity III (relative retention time is about 1.10) shall not exceed 0.1%, other single impurities shall not exceed 0.1%, and the total amount of impurities shall not exceed 0.5%.
R-enantiomer
take this product, add phosphate buffer (pH 11.0)(every 1000ml containing sodium phosphate 0.0028mol and disodium hydrogen phosphate 0.Ollmol) dissolve and quantitatively dilute to make a solution containing about 0.32mg per 1 ml, take 2ml precisely, put it in a 20ml measuring flask, dilute it to the scale with water, shake well, and use it as a test solution. According to the determination of high performance liquid chromatography (General rule 0512), using a1-acid glycoprotein bonded silica gel as filler; Phosphate buffer (pH 6.0) (containing sodium dihydrogen phosphate 0.0175mol and disodium hydrogen phosphate 0.0025mol per 1000ml)-Acetonitrile (85:15) as mobile phase, the detection wavelength was 302nm. Take about 18mg of omeprazole reference, put it in a 100ml measuring flask, add 5ml of methanol to dissolve, dilute it to the scale with the above phosphate buffer (pH 11.0), shake well, and take 2ml with precision, place the flask in 100ml, dilute to the scale with water, shake well, and inject into the liquid chromatograph in the order of enantiomeric peak and esomeprazole peak, the retention time of the esomeprazole peak is 4 to 5 minutes, and the degree of separation between the two peaks should be greater than 3. The sample solution 20u1 was accurately measured and injected into human liquid chromatograph, and the chromatogram was recorded. Calculated according to the peak area normalization method, the ruler-enantiomer should not exceed 0.5%.
residual solvent
take about 0.25g of this product, weigh it precisely, put it in a 20ml headspace bottle, add 2ml of N ,N-dimethylacetamide precisely, seal it, shake it well, and use it as a test solution; another 38mg of toluene was added to a 100ml measuring flask, diluted with N ,IV-dimethylacetamide to the scale, and then shaken; 62mg of acetone, 38mg of methanol and 25mg of acetonitrile were added to the flask, add 10ml of the above toluene solution to a 100ml measuring flask, dilute with IV,N-dimethylacetamide to the scale, shake well, take 2ml of the sample, and place it in a 20ml head-space flask, precision weight: 0.25g, Seal, shake, as a control solution. According to the determination method of residual solvent (General Principle 0861 second method), the capillary column with 6% cyanopropylphenyl-94% dimethyl polysiloxane (or similar polarity) as the stationary liquid is the column; The column temperature is 40°C, maintain 5 minutes, at a rate of 10°C per minute to 100°C, and then at a rate of 30°C per minute to 230°C, maintain 3 minutes; The injection temperature is 200°C, the detector temperature was 280°C; The headspace bottle equilibration temperature was 10°C and the equilibration time was 20 minutes. Take the reference solution into the headspace, record the chromatogram, the separation degree between the peaks of each component should be greater than 3.0. Then take the reference solution and the test solution into the headspace respectively, record the chromatogram
.
Figure, calculated by peak area according to external standard method. Toluene residues should not exceed 0.03%, acetone, methanol and acetonitrile residues should be in accordance with the provisions.
moisture
take this product, according to the moisture determination method (General 0832 first method 1), the water content shall not exceed 1.0%.
Heavy metals
take this product l. Add 4ml of 25% magnesium sulfate in dilute sulfuric acid solution to the Crucible, mix well, slowly burn to complete charring, burn at 700-800°C for 1 hour, cool, and dissolve the residue with 10ml of dilute hydrochloric acid, add 1 drop of phenolphthalein indicator solution, add concentrated ammonia solution Dropwise until the solution is pink, add glacial acetic acid Dropwise until the pink color disappears, add 0.5 of glacial acetic acid, filter, rinse filter with water, combine filtrate and wash solution, diluted with water to 20ml, inspection according to law (General Principles 0821 The first law), containing heavy metals shall not exceed 20 parts per million.
Last Update：2022-01-01 11:34:43
Esomeprazole - Content determination
Authoritative Data Verified Data
take this product about 0.3g, precision weighing, add new boiling cold water 50ml to dissolve, according to the potential titration method (General 0701), with hydrochloric acid titration solution (0.lmol/L) titration. Each 1 ml of hydrochloric acid titration solution (0.1 mol/L) corresponds to 36.74mg of C17H18N303SNa.
Last Update：2022-01-01 11:34:44
Esomeprazole - Category
Authoritative Data Verified Data
proton pump inhibitors.
Last Update：2022-01-01 11:34:44
Esomeprazole - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 11:34:45
Esomeprazole - Esomeprazole sodium for injection
Authoritative Data Verified Data
This product is a sterile lyophilized product of esomeprazole sodium. The content of esomeprazole sodium shall be 97.0% ~ 109.0% of the labeled amount calculated as esomeprazole (C17H18N3O3S).
trait
This product is a white or off-white mass or powder.
identification
- take an appropriate amount of this product (approximately equivalent to 40mg of esomeprazole), add 5mU of water, shake to dissolve it, and use it as a test solution; Use 0.03% ethylenediamine tetraacetic acid disodium solution as a control solution; take 0.5ml of test solution and 0.008% ml of control solution, add 1.0ml of human nickel sulfate solution, 1.0ml of 1 mol/L ammonia solution and ml of l% dimethylglyoxime ethanol solution successively, mix well and place for 1 minute, the test solution and the control solution should be colorless to yellowish, and the blank control test should be done at the same time, and the solution should be obviously red.
- take this product, add phosphate buffer (pH 11.0)(every 1000ml containing sodium phosphate 0.0028mol and disodium hydrogen phosphate 0.Ollmol) dissolved and quantitatively diluted to make esomeprazole approximately 0.Olmg solution was used as the test solution; Another 10 mg of omeprazole control substance was put into a 100ml measuring flask, and phosphate buffer solution (pH 11.4) was added (containing 0.0179mol of sodium phosphate and 0.0348mol of disodium hydrogen phosphate per 1000ml). 15ml was dissolved, diluted to the scale with water, and then shaken. 5ml was taken, placed in a 25ml measuring flask, diluted to the scale with the above phosphate buffer solution (pH 11.0), and shaken well to serve as a reference solution. According to the determination of high performance liquid chromatography (General 0512), the acidic glycoprotein bonded silica gel was used as the filler; Phosphate buffer solution (pH 6. 2) (containing sodium dihydrogen phosphate 0.0174mol and disodium hydrogen phosphate 0.00253mol per 1000ml)-acetonitrile (85:15) as mobile phase; The detection wavelength was 280nm, and the flow rate was 0.6ml per minute. Measure 20ul of the reference solution and the test solution respectively, inject the human liquid chromatograph, record the chromatogram, and the peak order is K-enantiomer and esomeprazole, esomeprazole peak retention time is about 4 minutes, the separation between the two peaks should meet the requirements. The retention time of the main peak of the test solution should be consistent with the retention time of the peak of esomeprazole in the control solution.
- 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 reference solution.
examination
- alkalinity take 1 bottle of this product, add 0.9% sodium chloride solution 5.2ml, shake to dissolve it, and then measure it according to law (General rule 0631). The pH value should be 10.0~11.0.
- clarity of solution take 1 bottle of this product, add 0.9% sodium chloride solution 5.2ml to dissolve, check according to law (General rule 0902 first method), the solution should be clarified.
- The test solution under the content determination item is taken as the test solution, and the content is determined according to the method under the content determination item, the sample solution should be injected within 15 minutes after preparation, and the chromatogram should be recorded to 2 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, according to the peak area normalization method, the impurity IV of esomeprazole sodium (relative retention time is about 0.26) shall not exceed 1.3%, esomeprazole sodium impurity I and esomeprazole sodium impurity III (relative retention time is about 1.5) shall not exceed 0.9%, esomeprazole sodium impurity II (relative retention time is about 0.32) impurity V with esomeprazole sodium (relative retention time is about 0.34) shall not exceed 0.3%, other individual impurities shall not exceed 0.2%, and the total amount of impurities shall not exceed 2.6%. The peaks in the chromatogram of the test solution which were smaller than 0.05% of the total peak area were ignored.
- take 5 bottles of this product for moisture, and determine the moisture content according to the moisture determination method (General rule 0832, first method 2). The moisture content shall not exceed 5.0%.
- The endotoxin of this product is determined by law (General 1143), and the amount of endotoxin in esomeprazole sodium per 1 mg should be less than 2.5EU.
- sterile take this product, after treatment with membrane filtration method, according to the law inspection (General 1101), should comply with the provisions.
- 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 (Microspher C18, 4.6mm X 100mm, 3um or performance equivalent column); with acetonitrile-phosphate buffer (pH 7.4) (every 0.001 ml containing sodium dihydrogen phosphate Mol and disodium hydrogen phosphate 0. 002 98mol)-tetrabutylammonium hydrogen sulfate solution [6.8g of tetrabutylammonium hydrogen sulfate, dissolved by adding 20ml of 1 mol /L sodium hydroxide solution, diluted to 7.4 ml with the above phosphate buffer solution (pH)](26:69=5) as mobile phase; The detection wavelength was 280nm. Take appropriate amounts of the reference substance of esomeprazole sodium impurity I and omeprazole, and add phosphate buffer (pH 11.0) under Item (2). Dissolve and dilute to prepare a mixed solution containing about 0.5 of each lml, and inject 20u1 into human liquid chromatograph to record the chromatogram. The retention time of omeprazole peak is 7-8 minutes, the degree of separation of the omeprazole peak from the impurity I peak should be greater than 3.0.
- assay 5 bottles of this product were dissolved and quantitatively diluted with phosphate buffer (pH 11.0) under Item (2) for identification to make esomeprazole 0.lmg solution, as a test solution, accurately take 20u1 injection liquid chromatograph, record chromatogram; Another omeprazole reference lOmg, precision weighing, 100ml flask, plus identification (2) the phosphate buffer solution (pH 11.4) was dissolved in 15ml, diluted to the mark with water, and measured by the same method. According to the external standard method to calculate the peak area, that is.
category
Same as esomeprazole sodium.
specification
40mg (based on C17HI9N303S)
storage
light shielding, closed storage.
Last Update：2022-01-01 11:34:46
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