EMtricitabine (EMtriva)
emtricitabine
CAS: 143491-57-0
Molecular Formula: C8H10FN3O3S
EMtricitabine (EMtriva) - Names and Identifiers
EMtricitabine (EMtriva) - Physico-chemical Properties
| Molecular Formula | C8H10FN3O3S |
| Molar Mass | 247.25 |
| Density | 1.82±0.1 g/cm3(Predicted) |
| Melting Point | 136-140°C |
| Boling Point | 443.3±55.0 °C(Predicted) |
| Specific Rotation(α) | D25 -133.60° (c = 0.23 in MeOH) |
| Flash Point | 221.889°C |
| Solubility | Chloroform (Slightly) |
| Vapor Presure | 0mmHg at 25°C |
| Appearance | White powder |
| Color | White to Pale Yellow |
| Maximum wavelength(λmax) | ['280nm(H2O)(lit.)'] |
| Merck | 14,3565 |
| pKa | 13.83±0.10(Predicted) |
| Storage Condition | Keep in dark place,Inert atmosphere,2-8°C |
| Refractive Index | 1.731 |
| MDL | MFCD00870151 |
EMtricitabine (EMtriva) - Risk and Safety
| RTECS | UW7360500 |
| HS Code | 2934990002 |
EMtricitabine (EMtriva) - Standard
Authoritative Data Verified Data
This product is (2R,5S)-5-fluoro -1-[2-hydroxymethyl-1, 3-oxosulfur heterocyclic penta-5-yl] cytosine. The content of C8H10FN303S shall be 98.0% ~ 102.0% calculated as dry product.
Last Update：2024-01-02 23:10:35
EMtricitabine (EMtriva) - Trait
Authoritative Data Verified Data
- This product is white or off-white powder or crystalline powder, slightly odorous.
- This product is soluble in water or methanol, slightly soluble in anhydrous ethanol, insoluble in ethyl acetate or dichloromethane.
specific rotation
take this product, precision weighing, add water to dissolve and quantitative dilution to make a solution containing about 2.5mg per lml, according to the law (General rule 0621), the specific rotation of a 105 ° to a 115 °.
Last Update：2022-01-01 15:36:28
EMtricitabine (EMtriva) - Differential diagnosis
Authoritative Data Verified Data
- take an appropriate amount of this product, add water to dissolve and quantitatively dilute to make a solution containing about 15ug per lml, and measure it by UV-Vis spectrophotometry (General rule 0401), there is maximum absorption at the wavelengths of 235nm and 280nm; The absorption coefficients are 325-355 and 350-380, respectively.
- 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.
- The infrared absorption spectrum of this product should be consistent with that of the reference product (General rule 0402).
Last Update：2022-01-01 15:36:29
EMtricitabine (EMtriva) - Exam
Authoritative Data Verified Data
acidity
take 0.10g of this product, Add 10ml of water to dissolve, and measure according to law (General rule 0631). The pH value should be 5.0~7.0.
chloride
take 0.10g of this product, add 25ml of water and 10ml of dilute nitric acid to dissolve, dilute to 40ml with water, and use it as a test solution, and check according to law (General rule 0801 ), must not be more concentrated (0.05%) than the control solution made from of standard sodium chloride solution.
sulfate
take 0.50g of this product, add 40ml of water and 2ml of dilute hydrochloric acid to dissolve, as a test solution, check according to law (General rule 0802), and compare with the control solution made of ML of standard potassium sulfate solution, no more concentrated (0.06%).
isomer
take about 10mg of this product, accurately weigh it, put it in a 10ml measuring flask, add 1 ml of methanol to dissolve it, dilute it to the scale with mobile phase, shake it well, and use it as a test solution; an appropriate amount was taken in a precise amount and quantitatively diluted with the mobile phase to prepare a solution containing about 3ug per 1 ml as a control solution. Determined by high performance liquid chromatography (General 0512). A polysaccharide derivative chiral chromatographic column (CHIRA L PAK AD-H, 4.6 mmX25Omm, 5um or equivalent chromatographic column with n-hexane-ethanol-methanol-trifluoroacetic acid-diethylamine (800:150:50:1 :1) as mobile phase; The detection wavelength was 280nm. Emtritabine isomer test system suitability test 5mg of mixed control was dissolved by adding 0.5ml of methanol and diluted to 5ml with mobile phase as system suitability solution. 20ul was injected into the liquid chromatograph and the chromatogram was recorded. The resolution of entronto-side peak and diastereomer peak (relative retention time is about 1.2) should be greater than 3.0. 20ul of the test solution and the control solution were respectively injected into the liquid chromatograph, and the chromatogram was recorded to 2 times of the retention time of the main component peak. If there is an isomer peak in the chromatogram of the test solution, the area of the enantiomer peak (relative retention time is about 0.6) multiplied by 1.11 shall not be greater than the area of the main peak of the control solution (0.3%), the area of the diastereomer peaks (relative retention times approximately 1.2 and 1.3) multiplied by 1.35 should not be greater than 0.2% of the area of the main peak of the control solution.
Related substances
take an appropriate amount of this product, precision weighing, and add mobile phase A to dissolve and dilute to prepare A solution containing about 0.75mg per 1 ml as A test solution. An appropriate amount was taken in A precise amount and quantitatively diluted with mobile phase A to prepare A solution containing 0.75ug per 1 ml as A control solution. In addition, take appropriate amounts of impurity I control, impurity II control, impurity III control, impurity IV control and impurity V Control, mobile phase A was added to dissolve and quantitatively dilute to prepare A solution containing about 0.75mg each in 1 ml as A reference stock solution. Take the appropriate amount of the above test solution and the reference stock solution, and quantitatively dilute with mobile phase A to make A mixed solution containing 0.75ug of each reference substance of each impurity in each lml, as a control solution. According to the determination of high performance liquid chromatography (General 0512), using eighteen alkyl silane bonded silica gel as filler; Take 1.54g /L ammonium acetate solution, adjust the pH to 4.0 with glacial acetic acid as mobile phase A, acetonitrile was used as mobile phase B. Gradient elution was carried out at a column temperature of 40 ° C. And a detection wavelength of 280nm. 20ul of the reference solution is injected into the liquid chromatograph, and the chromatogram is recorded. The relative retention time of each impurity is shown in the table below, and the separation degree between the entronto peak and the impurity IV peak should be greater than 5.0. Then the sample solution, the reference solution and the control solution of 20 u1 were injected into the liquid chromatograph respectively, and the chromatograms were recorded. If there are impurity peaks in the chromatogram of the test solution, the peak areas of impurity, impurity II, impurity III, impurity IV and impurity v shall be calculated according to the external standard method and shall not exceed 0.1%, 0.3%, 0.2%, respectively, 0.2% and 0.1%; The peak area of other individual impurities shall not be greater than the main peak area of the control solution (0.1%), and the sum of all impurities shall not exceed 1.0%. The peaks in the chromatogram of the test solution which are 0.5 times (0.05%) smaller than the main peak area of the control solution are ignored.
residual solvent
methanol, ethanol, tetrahydrofuran and benzene take this product about 0.2g, precision weighing, top empty bottle, Precision Add 10% N ,N-dimethylformamide 2ml to dissolve, Seal, as a test solution. Accurately weigh about 20mg of benzene, put it in a 100ml measuring flask, dilute it to the scale with N,N-dimethylformamide, shake it, accurately weigh 1ml, put it in a 100ml measuring flask, and precisely add N, 9ml of N-dimethylformamide, and accurately weigh about 0.5g of absolute ethanol, about 0.3g of methanol and about 72mg of tetrahydrofuran, put them in the same measuring flask, dilute them to the scale with water, and shake well, 5ml was accurately measured, placed in a 50ml measuring flask, diluted to the scale with 10% N,N-dimethylformamide, shaken, and 2ml was accurately measured, placed in a headspace bottle, sealed, and used as a reference solution. According to the determination method of residual solvent (General 0861 second method), a capillary column with 100% polydimethylsiloxane as stationary liquid (or similar polarity) was used; The initial temperature was 40°C and the time was maintained for 4 minutes, the temperature was raised to 180°C at a rate of 5°C per minute for 1 minute; The detector temperature was 250°C; The inlet temperature was 200°C. The Headspace bottle equilibration temperature was 80°C and the equilibration time was 30 minutes. Take the reference solution into the headspace, the separation degree of each peak should meet the requirements. The test solution and the reference solution were injected by Headspace, and the chromatograms were recorded. The peak area shall be calculated according to the external standard method and shall comply with the regulations.
n-hexane
take an appropriate amount of this product, add N, N-dimethylformamide to dissolve and dilute to make about O per lml. lg of the solution, as the test solution; Precision weighing N-hexane about 29mg, 100ml flask, diluted with N, N-dimethylformamide to the scale, shake, 5ml was precisely weighed, placed in a 50ml measuring flask, diluted to the scale with N, N-dimethylformamide, and shaken to serve as a reference solution. According to the determination method of residual solvent (General 0861 third method), a capillary column with 100% polydimethylsiloxane as stationary liquid (or similar polarity) was used; The initial temperature was 40°C and the time was maintained for 4 minutes, the temperature was raised to 180°C at a rate of 5°C per minute for 1 minute; The detector temperature was 250°C; The inlet temperature was 200°C. The lul of the test solution and the reference solution were accurately measured and injected into the gas chromatograph respectively, and the chromatograms were recorded. According to the external standard method to calculate the peak area, should comply with the provisions.
loss on drying
take this product, dry at 105°C for 3 hours, loss of weight shall not exceed 0.5% (General rule 0831).
ignition residue
take this product, put it in a platinum crucible, and check it according to law (General rule 0841). The residue left shall not exceed 0.1%.
Heavy metals
The residue left under the item of taking the ignition residue shall not contain more than 20 parts per million of heavy metal when examined by law (General rule 0821, Law II).
Last Update：2022-01-01 15:36:30
EMtricitabine (EMtriva) - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with eighteen alkyl silane was used as the filler; Water-methanol (80:20) was used as the mobile phase; The detection wavelength was 280nm, and the column temperature was 40°C. Take 10mg of entronto, put it in a 100ml measuring flask, add 3ml of lmol / L hydrochloric acid solution, heat it in water bath for 30 minutes, adjust it to neutral with lmol / L sodium hydroxide solution, and dilute it to scale with water, 20ul is injected into the liquid chromatograph, and the separation degree between the entronto peak and the impurity peak with relative retention time of about 1.3 (impurity IV) should be greater than 5.0.
assay
take about 10mg of this product, accurately weigh, put it in a 100ml measuring flask, add water to dissolve and dilute to the scale, shake, as a test solution, A 10ul injection liquid chromatograph was used for precise measurement, and the chromatogram was recorded. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 15:36:31
EMtricitabine (EMtriva) - Category
Authoritative Data Verified Data
antiviral drugs.
Last Update：2022-01-01 15:36:31
EMtricitabine (EMtriva) - Storage
Authoritative Data Verified Data
sealed and stored in a dry place.
Last Update：2022-01-01 15:36:31
EMtricitabine (EMtriva) - Entronto capsules
Authoritative Data Verified Data
This product contains emtritabine (C8H10FN3O3S) should be labeled the amount of 90.0% to 110.0%.
trait
The content of this product is white or white particles or powder.
identification
- take an appropriate amount of the contents of this product, add water to dissolve and dilute to prepare a solution containing 15% emtritabine per 1 ml, filter, the filtrate was measured by UV-Vis spectrophotometry (General 0401), and the maximum absorption was found at the wavelengths of 235nm and 280nm.
- 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.
- take an appropriate amount of the contents of this product (about 0.2g of emtritabine), add anhydrous ethanol (10ml), shake to dissolve emtritabine, filter, the filtrate was evaporated to dryness in a water bath at 80 ° C., and the residue was dried at 105 ° C. For 1 hour and measured according to law (General rule 0402). The infrared absorption spectrum of this product should be consistent with that of the reference product.
examination
- Related Substances: take the contents of this product, grind it finely, weigh an appropriate amount (about 150mg equivalent to emtritabine), put it in A 200ml measuring flask, and add an appropriate amount of mobile phase A, shake to dissolve emtronto, dilute to the scale with mobile phase A, shake, filter, and take the filtrate as the test solution; Take appropriate amount with precision, A solution containing 0.75ug per 1 ml was prepared as A control solution by quantitative dilution with mobile phase A. In addition, take appropriate amounts of impurity I reference substance, impurity II reference substance, impurity III reference substance, impurity IV reference substance and impurity V reference substance for precision weighing, mobile phase A was added and dissolved and diluted to prepare A solution containing about 0.75mg each in 1 ml as A reference stock solution. Take the appropriate amount of the above test solution and the reference stock solution, and quantitatively dilute with mobile phase A to prepare A mixed solution containing 0.75ug each of emtritabine and impurities per lml, as a control solution. According to the high performance liquid chromatography (General 0512) determination, with eighteen alkyl silane bonded silica gel as filler; Take 1.54g/L ammonium acetate solution, with glacial acetic acid adjustment pH 4.0, as mobile phase A, acetonitrile was used as mobile phase B. Gradient elution was carried out at a column temperature of 40 ° C. And a detection wavelength of 280nm. The reference solution 20 u1 is injected into the liquid chromatograph, and the chromatogram is recorded. The relative retention time of each impurity is shown in the table below, and the separation degree between the entronto peak and the impurity IV peak should be greater than 5.0. Then the sample solution, the reference solution and the control solution of 20 u1 were injected into the liquid chromatograph respectively, and the chromatograms were recorded. If there are impurity peaks in the chromatogram of the test solution, the peak areas of impurity I, impurity II, impurity III, impurity IV and impurity V shall not exceed 0.1%, 0.5%, 0.2% respectively based on the external standard method, 0.2% and 0.1%; The peak area of other individual impurities shall not be greater than the main peak area of the control solution (0.1% ), and the sum of all impurities shall not exceed 1.0%. The peaks in the chromatogram of the test solution which are 0.5 times (0.05%) smaller than the main peak area of the control solution are ignored.
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 second method), with water 1000ml as the dissolution medium, the speed is 50 rpm, according to the law, after 30 minutes, take the appropriate amount of solution, filter, take the appropriate amount of filtrate, and dilute it quantitatively with water to make a solution containing about 20ug per 1 ml, the absorbance was measured at a wavelength of 0401 NM according to UV-Vis spectrophotometry (general rule). An appropriate amount of the reference substance of entronto, precision weighing, dissolving with water and quantitatively diluting it to make a solution containing about 20ug per 1 ml. The same method was used to determine and calculate the dissolution amount of each particle. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
- others should comply with the relevant provisions under the capsule (General 0103).
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; Water-methanol (80:20) as mobile phase; Detection wavelength was 280nm, column temperature was 40°C. Take 10 mg of entronto, put it in a 100ml measuring flask, add 3ml of lmol/L salt solution, heat it in water bath for 30 minutes, adjust it to neutral with lmol/L sodium hydroxide solution, and dilute it to scale with water, 20ul is injected into the liquid chromatograph, and the separation degree between the entronto peak and the impurity peak with relative retention time of about 1.3 should be greater than 5.0.
- determine the contents under the item of loading difference, grind them finely, weigh an appropriate amount (approximately equal to 10 mg of entronto), put them in a 100ml measuring flask, and add an appropriate amount of water, dissolve by ultrasound, dilute to the scale with water, shake well, filter, take the filtrate as the test solution, and inject lol into the liquid chromatograph to record the chromatogram; the control substance of emtritabine was measured with the same method. According to the external standard method to calculate the peak area, that is.
category
TNB.
specification
0.2g
storage
sealed and stored in a dry place.
Last Update：2022-01-01 15:36:32
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Product Name: Emtricitabine Visit Supplier Webpage Request for quotationCAS: 143491-57-0
Tel: 0714-3999186
Email: 2853786052@qq.com
Mobile: 86+15671228036
QQ: 2853786052
Wechat: 15671228036
Product Name: emtricitabine Request for quotation
CAS: 143491-57-0
Tel: 0086-551-65418684
Email: sales@tnjchem.com
info@tnjchem.com
Mobile: 0086 189 4982 3763
QQ: 2881500840
Wechat: 0086 189 4982 3763
WhatsApp: 0086 189 4982 3763
Product List: View Catalog
CAS: 143491-57-0
Tel: 0086-551-65418684
Email: sales@tnjchem.com
info@tnjchem.com
Mobile: 0086 189 4982 3763
QQ: 2881500840
Wechat: 0086 189 4982 3763
WhatsApp: 0086 189 4982 3763
Product List: View Catalog
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Product Name: Emtritabine Visit Supplier Webpage Request for quotationCAS: 143491-57-0
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