9-[2-[bis[(pivaloyloxy)methoxy]phosphinyl]methoxy]ethyl]adenine
Adefovir Dipivoxyl
CAS: 142340-99-6
Molecular Formula: C20H32N5O8P
9-[2-[bis[(pivaloyloxy)methoxy]phosphinyl]methoxy]ethyl]adenine - Names and Identifiers
| Name | Adefovir Dipivoxyl |
| Synonyms | 142340-99-6 ADEFOVIR PIVOXIL Adefovir Dipivoxl Adefovir Dipivoxyl Adefovir dipivoxil 9-[2-[bis[(pivaloyloxy)methoxy]phosphinyl]methoxy]ethyl]adenine 3-{[2-(6-amino-9H-purin-9-yl)ethoxy]methyl}-8,8-dimethyl-3-oxido-7-oxo-2,4,6-trioxa-3lambda~5~-phosphanon-1-yl 2,2-dimethylpropanoate |
| CAS | 142340-99-6 |
| InChI | InChI=1/C20H32N5O8P/c1-19(2,3)17(26)30-11-32-34(28,33-12-31-18(27)20(4,5)6)13-29-8-7-25-10-24-14-15(21)22-9-23-16(14)25/h9-10H,7-8,11-13H2,1-6H3,(H2,21,22,23) |
9-[2-[bis[(pivaloyloxy)methoxy]phosphinyl]methoxy]ethyl]adenine - Physico-chemical Properties
| Molecular Formula | C20H32N5O8P |
| Density | 1.35g/cm3 |
| Melting Point | 98-102℃ |
| Boling Point | 641°C at 760 mmHg |
| Flash Point | 341.5°C |
| Solubility | ethanol: 50 mg/mL |
| Vapor Presure | 2.52E-16mmHg at 25°C |
| Appearance | solid |
| Storage Condition | 2-8℃ |
| Refractive Index | 1.569 |
| MDL | MFCD00869897 |
| Physical and Chemical Properties | Melting point 98-102°C |
| Use | With broad-spectrum antiviral activity, can be used for the treatment of chronic hepatitis B |
9-[2-[bis[(pivaloyloxy)methoxy]phosphinyl]methoxy]ethyl]adenine - Standard
Authoritative Data Verified Data
This product is [[2-(6-amino-9h-purin-9-yl) ethoxy] methyl] phosphonic acid bis (pivalyloxymethyl) Ester. The content of C20H32N5O8P shall be between 97.5% and 102.0% calculated as water-free and solvent-free.
Last Update：2024-01-02 23:10:35
9-[2-[bis[(pivaloyloxy)methoxy]phosphinyl]methoxy]ethyl]adenine - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline powder.
- This product is soluble in ethanol and almost insoluble in water.
Last Update：2022-01-01 13:31:59
9-[2-[bis[(pivaloyloxy)methoxy]phosphinyl]methoxy]ethyl]adenine - Differential diagnosis
Authoritative Data Verified Data
- take this product, add 0. The 1 mol/ L hydrochloric acid solution is prepared to contain about 20ug per 1 ml of solution, and has a maximum absorption at a wavelength of 0401 nm as measured by ultraviolet-visible spectrophotometry (general).
- 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 about 50mg of this product, put it in an onyx mortar, add 3-5 drops of acetone to dissolve. After the solvent was evaporated to dryness, an oily substance appeared, and then a white solid was milled to precipitate. The drying was continued for about 15 minutes under an infrared lamp, and the infrared absorption pattern should be consistent with that of the control article treated by the same method (General rule 0402).
- take this product about 0.lg and anhydrous sodium carbonate lg were placed in a porcelain crucible, mixed well, heated and melted, cooled, dissolved by adding 20ml of water, filtered, and the filtrate was made neutral by adding nitric acid, identification reaction of phosphate (General rule 0301).
Last Update：2022-01-01 13:32:00
9-[2-[bis[(pivaloyloxy)methoxy]phosphinyl]methoxy]ethyl]adenine - Exam
Authoritative Data Verified Data
clarity and color of solution
take 0.lg of this product, and add 0902 of methyl alcohol 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 first method).
Related substances
new system for clinical use. Take this product, precision weighing, add diluent [0.025mol/L potassium dihydrogen phosphate solution-acetonitrile (82:18 )] Dissolved and quantitatively diluted to prepare about 1 mg solution per 1ml, as a test solution; 1ml was accurately measured, placed in a 100ml measuring flask, diluted to a scale with a diluent, and shaken to serve as a control solution. Take the reference substance of Adefovir dipivoxil, precisely weigh, add diluent to dissolve and quantitatively dilute to make a solution containing 5ug per lml, as the reference solution (1); Take the reference substance of Adefovir dipivoxil, precisely weigh, A solution containing 5ug per 1ml was prepared as a control solution (2) by dilution and quantitative dilution. According to the chromatographic conditions under the content determination item, the sample solution, the control solution and the reference solution (1) and (2) are respectively injected into the liquid chromatograph and the chromatograms are recorded. If there are chromatographic peaks with the same retention time as adefovir and Adefovir dipivoxil in the chromatogram of the test solution, the peak area shall be calculated according to the external standard method, and the content of Adefovir dipivoxil and Adefovir dipivoxil shall not exceed 1.0% and 0.5% respectively; except for adefovir monoester and adefovir peak, the peak area of other single impurities shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution; The total amount of impurities shall not exceed 2.0%.
residual solvent
acetone, dichloromethane, acetonitrile, toluene, take this product about 80mg, precision weighing, top empty bottle, precision plus N, N-dimethylformamide lml to dissolve, sealed, as a test solution; Take acetone lOOmg, precision weighing, in a 10ml measuring flask containing an appropriate amount of N, N-dimethylformamide, dilute with N, N-dimethylformamide to the scale, shake; take another 120mg of dichloromethane, 82mg of acetonitrile and 178mg of toluene for precision weighing, and place them in 100ml measuring flasks containing appropriate amount of N, N-dimethylformamide respectively, dilute with dimethylformamide to the scale, and shake well, take 1ml of each precision volume, put it in a 25ml measuring flask, dilute it to the scale with N, N-dimethylformamide, shake it well, and use it as a mixed reference solution. Take 1ml of the precision volume, place it in the top empty bottle, and seal it, as a control solution. According to the determination method of residual solvent (General Principle 0861 second method), use 6% cyanopropyl phenyl-94% dimethyl siloxane (or polar similar) as the stationary liquid capillary column, the initial column temperature is 40 deg C, hold for 5 minutes, raise to 150°C at a rate of 10°C per minute and then to 220°C at a rate of 40°C per minute, with an inlet temperature of 200°C and a detector temperature of 250°C; the Headspace bottle equilibration temperature was 90°C and the equilibration time was 30 minutes. The reference solution and the test solution were injected into the 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,N-dimethylformamide
take 0.8g of this product, accurately weigh it, put it in a 10ml children's bottle, add anhydrous ethanol to dissolve it and dilute it to the scale, shake it well, and use it as a test solution. Take 350mg of dimethylformamide, precision weighing, set in 100ml measuring flask, dilute to scale with absolute ethanol, shake well, take 1ml with precision, set in 50ml measuring flask, dilute to scale with absolute ethanol, shake well, as a control solution. According to the determination method of residual solvent (General 0861 third method), a capillary column (HP-mnowax or equivalent) with bonded cross-linked polyethylene glycol as stationary liquid was used, and the initial column temperature was 60 ° C. For 3 minutes, the temperature was increased to 240°C at a rate of 40°C per minute for 4 minutes, the inlet temperature was 250°C and the detector temperature was 280°C. Take 1ul of each sample solution and reference solution, respectively inject human gas chromatograph, record the chromatogram, and calculate the peak area according to the external standard method.
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 lg of this product, and add 0821 of ethyl yeast to dissolve it, and check it according to law (General rule first law). The heavy metal content shall not exceed 10 parts per million.
Last Update：2022-01-01 13:32:01
9-[2-[bis[(pivaloyloxy)methoxy]phosphinyl]methoxy]ethyl]adenine - 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 A filler; Mobile phase A was 0.025mol/L potassium dihydrogen phosphate buffer, mobile phase B was acetonitrile, and the gradient elution was carried out according to the following table, and the detection wavelength was 260mn. Take Adefovir dipivoxil, Adefovir dipivoxil and Adefovir dipivoxil reference products, and add diluent to make solutions containing Adefovir dipivoxil, Adefovir dipivoxil and Adefovir dipivoxil 0.5ug, 0.5ug and 0.2mg per 1 mL respectively, if necessary, the solution was dissolved by ultrasound in an ice bath, and l0ul was injected into the liquid chromatograph as a solution suitable for the system, and the chromatogram was recorded. The degree of separation between the adefovir peak and the adefovir monoester peak should meet the requirements, and the degree of separation between the adefovir monoester peak and the Adefovir dipivoxil peak should be greater than 9.
assay
take this product, precision weighing, add appropriate amount of diluent to dissolve and dilute to make a solution containing about 0.2mg per 1 ml, as a test solution, 10u1 was injected into the liquid chromatograph accurately, and the chromatogram was recorded. Another reference substance of Adefovir dipivoxil was taken and determined by the same method. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 13:32:01
9-[2-[bis[(pivaloyloxy)methoxy]phosphinyl]methoxy]ethyl]adenine - Category
Authoritative Data Verified Data
nucleoside antiviral drugs.
Last Update：2022-01-01 13:32:01
9-[2-[bis[(pivaloyloxy)methoxy]phosphinyl]methoxy]ethyl]adenine - Storage
Authoritative Data Verified Data
shading, sealing, storage in cold place.
Last Update：2022-01-01 13:32:02
9-[2-[bis[(pivaloyloxy)methoxy]phosphinyl]methoxy]ethyl]adenine - Adefovir Dipivoxil Tablets
Authoritative Data Verified Data
This product contains Adefovir dipivoxil (C20H32N5O8P) should be 90.0% to 110.0% of the label amount.
trait
This product is white or off-white.
identification
- take an appropriate amount of fine powder of this product and add 0.lmol/ L hydrochloric acid solution is made into a solution containing 20ug of Adefovir dipivoxil per lml, filtered, and the filtrate is determined by UV-Vis spectrophotometry (General rule 0401), there is an absorption maximum at a wavelength of 259nm.
- 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
- new system of related substances in clinical use. Take an appropriate amount of fine powder of this product (about 10mg equivalent to Adefovir dipivoxil), weigh it accurately, put it in a 10ml measuring flask, and add an appropriate amount of diluent [0.025mol/L potassium dihydrogen phosphate solution-acetonitrile (82:18)], shake to dissolve Adefovir dipivoxil, dilute to the scale with diluent, shake, filter, and take the filtrate as the test solution; Take 1ml of the test solution with precision, in a 100ml measuring flask, dilute to the scale with diluent, and shake to serve as a control solution. In addition, a reference product of adefovir monoester was carefully weighed, dissolved and quantitatively diluted with a diluent to prepare a solution containing lOug per 1 ml, which was used as a reference solution. According to the chromatographic conditions under the content determination item, the test solution, the control solution and the reference solution are respectively injected into the human liquid chromatograph. If there is a chromatographic peak with the same retention time as Adefovir dipivoxil in the chromatogram of the test solution, the peak area shall be calculated according to the external standard method, and the content of Adefovir dipivoxil shall not exceed 2.5% of the labeled amount of Adefovir dipivoxil; the Peak area of other individual impurities shall not be greater than the main peak area of the control solution (1.0%); The sum of the peak areas of other impurities shall not be greater than 2 times the main peak area of the control solution (2.0%).
- dissolution of this product, according to the dissolution and release determination method (General 0931 second method), with 0.Olmol/L hydrochloric acid solution (600ml) is the dissolution medium, and the rotation speed is 50 revolutions per minute. After 30 minutes, 5ml of the solution is taken, filtered, and the filtrate is taken as the test solution; another reference product of Adefovir dipivoxil, precision weighing, adding 0.01mol/L hydrochloric acid solution to dissolve and quantitatively dilute to make a solution containing about 16ug per lml. If necessary, put ultrasound in ice bath to dissolve, as a control solution. The above two solutions were taken separately, and the absorbance was measured at a wavelength of 0401 NM according to ultraviolet-visible spectrophotometry (general rule), and the elution amount of each tablet was calculated. The limit is 80% of the labeled amount and shall be in accordance with the provisions. The content uniformity of
- shall be calculated from the content of each tablet measured under the content determination item, and shall comply with the regulations (General rule 0941).
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
- test according to high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler, mobile phase A is 0.025mol/L potassium dihydrogen phosphate buffer, mobile phase B is acetonitrile, gradient elution is carried out according to the following table, the detection wavelength is 260nm; Take Adefovir dipivoxil and Adefovir dipivoxil reference, add diluent to dissolve and dilute to make about 0.5ug Adefovir dipivoxil and 0.2mg Adefovir dipivoxil in each lml, respectively, if necessary, it should be dissolved by ultrasound in ice bath. As the applicable solution of the system, 10ul is injected into the liquid chromatograph, and the chromatogram is recorded. The resolution of Adefovir dipivoxil peak and Adefovir dipivoxil monoester peak should be greater than 9.
- determination of 10 tablets of this product, respectively, in 50ml measuring flask, plus the appropriate amount of diluent, ultrasonic dissolution of Adefovir dipivoxil, cool, dilute to the scale with diluent, shake, filter, take the continued filtrate as the test solution; Take the reference product of Adefovir dipivoxil, weigh it precisely, add the diluent to dissolve and quantitatively dilute to make a solution containing 0.2mg per 1 ml, if necessary, it was dissolved by ultrasound in an ice bath as a control solution. Take sample solution and reference solution 10 u1 respectively, inject human liquid chromatograph, record chromatogram, calculate the content of each tablet by peak area according to external standard method, calculate the average content of 10 tablets, that's right.
category
Same as Adefovir dipivoxil.
specification
1Omg
storage
sealed and stored in a dry place below 25°C.
Last Update：2022-01-01 13:32:03
9-[2-[bis[(pivaloyloxy)methoxy]phosphinyl]methoxy]ethyl]adenine - Dipivoxil capsules
Authoritative Data Verified Data
This product contains Adefovir dipivoxil (C20H32N5O8P) should be 90.0% to 110.0% of the label amount.
trait
The content of this product is white or white powder.
identification
- take an appropriate amount of fine powder of this product and add 0.lmol /L hydrochloric acid solution is made into a solution containing 20ug of Adefovir dipivoxil per lml, filtered, and the filtrate is determined by UV-Vis spectrophotometry (General rule 0401), there is an absorption maximum at a wavelength of 259nm.
- 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
- new system of related substances in clinical use. Take an appropriate amount of fine powder of this product (about 10 mg equivalent to Adefovir dipivoxil), set it in a 10ml measuring flask, and add an appropriate amount of diluent [0.025mol/L potassium dihydrogen phosphate solution-acetonitrile (82:18)], shake to dissolve Adefovir dipivoxil, dilute to the scale with diluent, shake, filter, and take the filtrate as the test solution. Take 1ml of precision measurement, put it in a 100ml measuring flask, dilute to the scale with diluent, shake, as a control solution. Another reference product of adefovir monoester was carefully weighed, dissolved and quantitatively diluted with diluent to prepare a solution containing about 10ug per 1 ml, which was used as a reference solution. According to the chromatographic conditions under the content determination item, 10 u1 of the sample solution, the control solution and the reference solution are respectively injected into the liquid chromatograph, and the chromatograms are recorded. If there is a chromatographic peak with the same retention time as Adefovir dipivoxil in the chromatogram of the test solution, the peak area shall be calculated according to the external standard method, and the content of Adefovir dipivoxil shall not exceed 2.5% of the labeled amount of Adefovir dipivoxil; the Peak area of other individual impurities shall not be greater than the main peak area of the control solution (1.0% ) , and the sum of the peak areas of other impurities shall not be greater than 2 times (2.0%) of the main peak area of the control solution.
- dissolution of this product, plus sedimentation basket, according to the dissolution and release determination method (General 0931 second method), with 0.500ml of 1 mol/L hydrochloric acid solution is the dissolution medium, the rotation speed is 50 revolutions per minute, and the operation is carried out according to law. After 30 minutes, 5ml of the solution is taken, filtered, and the filtrate is taken as the test solution; an appropriate amount of Adefovir dipivoxil control, precision weighing, plus O. 1 mol/L hydrochloric acid solution was dissolved and quantitatively diluted to give a solution containing about 20ug per 1 ml. If necessary, the solution was dissolved by ultrasonication in an ice bath and used as a reference solution. The above two kinds of solutions were taken separately, and the absorbance was measured at the wavelength of 0401 nm by ultraviolet-visible spectrophotometry (general rule), and the dissolution amount of each particle was calculated. The limit shall be 80% of the marked children and shall comply with the regulations. The content uniformity of
- shall be calculated from the content of each capsule measured under the content determination item, and shall comply with the regulations (General 0941).
- others should comply with the relevant provisions under the capsule (General 0103).
Content determination
- test according to high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler, mobile phase A was 0.O25mol/L potassium dihydrogen phosphate buffer, mobile phase B was acetonitrile, gradient elution was carried out according to the following table, and the detection wavelength was 260mn, add diluent solution to dissolve and dilute to make a solution containing 0.5ug of adefovir monoester and 0.2mg of Adefovir dipivoxil in each lml respectively. If necessary, the solution is dissolved by ultrasound in an ice bath, take the liquid chromatograph to record the chromatogram. The resolution of Adefovir dipivoxil peak and Adefovir dipivoxil peak should be greater than 9.
- determination Method: Take 10 capsules of this product, pour the contents into different 50ml bottles, rinse the capsule shell with diluent, wash it into the measuring bottle, add the appropriate amount of diluent, shake to dissolve Adefovir dipivoxil, dilute to the scale with diluent, shake, filter, and take the filtrate as the test solution, A solution containing 0.2mg per 1 ml was prepared by dissolving and quantitatively diluting with a diluent. If necessary, the solution was dissolved by ultrasonication in an ice bath and used as a reference solution. The sample solution and the reference solution are respectively injected into the liquid chromatograph to record the chromatogram. The content of each particle is calculated by the peak area according to the external standard method, and the average content of 10 particles is calculated.
category
Same as Adefovir dipivoxil.
specification
1Omg
storage
sealed and stored in a dry place at 2 to 20°C.
Last Update：2022-01-01 13:32:04
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Product Name: Adefovir Dipivoxyl Request for quotation
CAS: 142340-99-6
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: 142340-99-6
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
Multiple Specifications
Product Name: Adefovir Dipivoxil Visit Supplier Webpage Request for quotationCAS: 142340-99-6
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
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