D-(-)-a-amino-p-hydroxybenzylpenicillintrydrate
Amoxicillin
CAS: 26787-78-0
Molecular Formula: C16H19N3O5S
D-(-)-a-amino-p-hydroxybenzylpenicillintrydrate - Names and Identifiers
D-(-)-a-amino-p-hydroxybenzylpenicillintrydrate - Physico-chemical Properties
| Molecular Formula | C16H19N3O5S |
| Molar Mass | 365.4 |
| Density | 1.54±0.1 g/cm3(Predicted) |
| Melting Point | 140 °C |
| Boling Point | 743.2±60.0 °C(Predicted) |
| Flash Point | 403.3°C |
| Water Solubility | 4g/L at 25℃ |
| Solubility | DMSO mg/mL Water mg/mL Ethanol mg/mL |
| Vapor Presure | 0Pa at 25℃ |
| Appearance | Solid |
| Color | Light yellow |
| Merck | 13,582 |
| BRN | 7507120 |
| pKa | pKa 2.4 (Uncertain) |
| Storage Condition | 2-8°C |
| Stability | Stable. Incompatible with strong oxidizing agents. |
| MDL | MFCD00056860 |
| Physical and Chemical Properties | White crystalline powder. The melting point of trihydrate is 195 ℃ (decomposition), solubility (mg/ml), water 4.0, methanol 7.5, anhydrous ethanol 3.4. The pH of the aqueous solution was about 4.7. The taste was slightly bitter. |
D-(-)-a-amino-p-hydroxybenzylpenicillintrydrate - Risk and Safety
| Risk Codes | 42/43 - May cause sensitization by inhalation and skin contact. |
| Safety Description | S22 - Do not breathe dust. S36/37 - Wear suitable protective clothing and gloves. |
| WGK Germany | 2 |
| RTECS | XH8300000 |
| HS Code | 29411000 |
D-(-)-a-amino-p-hydroxybenzylpenicillintrydrate - Standard
Authoritative Data Verified Data
(2S,5R,6R)-3, 3-dimethyl-6-[(1R)-(-)-2-amino -2-(4-hydroxyphenyl) acetamido]-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid trihydrate. Calculated as anhydrous, containing amoxicillin (based on C16H19N3O5S) shall not be less than 95.0%.
Last Update：2024-01-02 23:10:35
D-(-)-a-amino-p-hydroxybenzylpenicillintrydrate - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline powder.
- This product is slightly soluble in water and almost insoluble in ethanol.
specific rotation
take this product, precision weighing, water dissolution and quantitative dilution of about 2mg per lml solution, according to the law (General 0621), specific rotation of 290 ° to 315 °.
Last Update：2022-01-01 13:31:34
D-(-)-a-amino-p-hydroxybenzylpenicillintrydrate - Differential diagnosis
Authoritative Data Verified Data
- about 0.125g of this product and about 4.6% g of amoxicillin reference substance are respectively dissolved and diluted with sodium bicarbonate solution to prepare a solution containing about 10 mg per 1 ml as the test solution and the reference solution; in addition, the appropriate amounts of amoxicillin control and cefazolin control were dissolved and diluted by adding 4.6% sodium bicarbonate solution to prepare solutions containing about 10 mg and 5mg respectively per 1 ml as the system applicable solution. According to the thin layer chromatography (General 0502) test, absorb the above three solutions 4u1, respectively, on the same silica gel GF254 thin layer plate, with ethyl acetate-acetone-glacial acetic acid-water (5:2:2:1) for the development of the agent, expand, dry, set the UV lamp 254mn under the inspection. The system suitability solution should show two clearly separated spots. The position and color of the main spot displayed by the test solution should be the same as the position and color of the main spot of the reference 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.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 441).
- two items (1) and (2) above can be selected as one item.
Last Update：2022-01-01 13:31:35
D-(-)-a-amino-p-hydroxybenzylpenicillintrydrate - Exam
Authoritative Data Verified Data
acidity
take this product, add water to make a solution containing 2mg per lml, according to the law (General 0631) ,pH value should be 3.5~5.5.
clarity of solution
take 5 parts of this product, each l. Add 10ml of 0.5mol/L hydrochloric acid solution to observe immediately after dissolving. After adding 10ml of 2mol/L ammonia solution respectively, it was immediately observed that the solution should be clear. If it is turbid, it should not be more concentrated compared with No. 2 Turbidity standard solution (General 0902 first method).
Related substances
take an appropriate amount of this product, precision weighing, and add mobile phase A to dissolve and quantitatively dilute to make about 2 per 1 ml. 0 mg of the solution was used as the test solution; An appropriate amount of amoxicillin reference substance was added to precisely weigh, and mobile phase A was added to dissolve and quantitatively dilute to prepare A solution containing about 20ug per 1 ml as the control solution. According to the determination of high performance liquid chromatography (General 0512), silica gel was bonded with eighteen alkyl silane as the filler; 0.05mol/L phosphate buffer solution (0.05mol/L potassium dihydrogen dihydrate solution, with 2mol/L potassium hydroxide solution to adjust the pH value to 5.0)-acetonitrile (99:1) as mobile phase A; 0.05mol/L phosphate buffer (pH 5.0)-acetonitrile (80:20) mobile Phase B; The detection wavelength was 254nm. First with mobile phase A- mobile phase B(92:8) isocratic elution, after the completion of amoxicillin peak elution immediately after the following linear gradient elution. The appropriate amount of amoxicillin system applicable reference substance is taken, dissolved and diluted with mobile phase A to make A solution containing about 2.0 mg per 1 ml, and 20u1 is injected into the liquid chromatograph. The chromatogram recorded should be consistent with the standard spectrum. Accurately take 20ul of test solution and control solution respectively, inject human liquid chromatograph, record chromatogram, if there are impurity peaks in the chromatogram of test solution, the single impurity peak area shall not be greater than the main peak area of the control solution (1.0% ) , and the sum of each impurity peak area shall not be greater than 3 times (3.0%) of the main peak area of the control solution, the peaks in the chromatogram of the test solution which were 0.05 times smaller than the main peak area of the control solution were ignored.
amoxicillin
polymers were determined by size exclusion chromatography (General 0514).
chromatographic conditions and system suitability test
with dextran gel CM0(40 ~ 120um) as the filler, the inner diameter of the glass column is 1.0~1.4, the length of the column is 30 ~ 40cm, mobile phase A was 8.0 mol/L phosphate buffer (pH 0.05) [0.05mol/L disodium hydrogen phosphate solution -0.05mol/L sodium dihydrogen phosphate solution (95:5 )], mobile phase B was water, the flow rate was 1.5ml per minute and the detection wavelength was 254nm. 2000~200u1 of 100 Blue dextran solution was injected into the liquid chromatograph, and the mobile phase A and B were used as the mobile phase to measure, and the chromatogram was recorded. According to the Blue dextran 2000 peak, the number of theoretical plates is not less than 500, and the tailing factor should be less than 2.0. The ratio of the retention time of the Blue dextran 2000 peak in the two mobile phase systems should be between 0.93 and 1.07, the ratio of the retention time of the main peak of the control solution and the polymer peak in the test solution to the Blue dextran 2000 peak in the corresponding chromatography system should be between 0.93 and 1.07. Weigh about 0.2g of amoxicillin into a 10ml measuring flask, add 4ml of 2% anhydrous sodium carbonate solution to dissolve, dilute to the mark with 0.3mg/ml Blue dextran 2000 solution, and shake well. Measure 100-200ul and inject it into human liquid chromatograph, measure with mobile phase A, and record chromatogram. The ratio of the peak height of the polymer to the valley height between the monomer and the polymer should be greater than 2.0. In addition, the mobile phase B is used as the mobile phase, and 100-200ul of the control solution is accurately measured, and the sample is continuously injected for 5 times. The relative standard deviation of the peak area should not be more than 5.0%.
preparation of control solution
take an appropriate amount of penicillin control, weigh it precisely, add water to dissolve and quantitatively dilute to make a solution containing about 0.2mg per 1 ml.
assay
take about 0.2g of this product, weigh it accurately, put it in a 10ml measuring flask, add 4ml of 2% anhydrous sodium carbonate solution to dissolve it, dilute it with water to the scale, shake it well, immediately, 100-200u1 was accurately weighed and human chromatograph was injected. Mobile phase A was used as mobile phase for measurement, and the chromatogram was recorded. In addition, 100~200m1 of the control solution was injected into the human chromatograph, and the mobile phase B was used as the mobile phase, and the same method was used for determination. The amount of amoxicillin polymer shall not exceed 0.2, calculated by the area of penicillin peak and multiplied by a correction factor of 0.15%.
residual solvent
precision weighing this product 0.25g, top empty bottle, precision plus N,N-dimethylacetamide 5ml dissolved, sealed, as a test solution; accurately weigh appropriate amount of acetone and dimethane, and quantitatively dilute with N,N-dimethylacetamide to make a solution containing acetone 40ug and dichloromethane 30ug per lml, accurately weigh 5ml, and place it in the top empty bottle, sealed as a control solution. Determined according to the residual solvent assay (General 0861 second method). The capillary column with 6% cyanopropylphenyl-94% dimethylpolysiloxane (or similar polarity) as stationary liquid was used as the chromatographic column; The initial temperature was 40 ° C. And maintained for 4 minutes, then the temperature is raised to 200°C at a rate of 30°C per minute for 6 minutes; The inlet temperature is 300°C, the detector temperature is 250°C, and the equilibrium temperature of the headspace bottle is 80°C, the equilibration time was 30 minutes; The reference solution was injected in the headspace, and the chromatogram was recorded. The resolution of acetone and dichloromethane should meet the requirements. The test solution and the reference solution were injected by Headspace, and the chromatograms were recorded. According to the external standard method, the residual amount of dichloromethane shall not exceed 0.12%, and the residual amount of acetone shall comply with the regulations.
moisture
take this product, according to the moisture determination method (General 0832 first method 1), the moisture content should be 12.0% ~ 15.0%.
ignition residue
take l.Og of this product and check it according to law (General rule 0841). The residue left shall not exceed 1.0%.
Last Update：2022-01-01 13:31:36
D-(-)-a-amino-p-hydroxybenzylpenicillintrydrate - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with octylsilane as filling agent; 0.05mOl / L potassium dihydrogen phosphate solution (adjusted to pH 5.0 with 2mOl/L potassium hydroxide solution)-acetonitrile (97.5:2.5) the detection wavelength was 254nm. Take about 25mg of the applicable reference substance of amoxicillin system, put it in a 50ml measuring flask, dissolve it with mobile phase and dilute it to the scale, shake it, take 20u1 and inject it into human Liquid Chromatograph. The chromatogram recorded should be consistent with the standard chromatogram.
assay
take about 25mg of this product, precision weighing, put it in 50ml measuring flask, add mobile phase to dissolve and dilute to the scale, shake, as a test solution, precision volume 20u1 injection human liquid chromatography. Instrument, record the chromatogram; Take an appropriate amount of amoxicillin reference, the same method for determination. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 13:31:37
D-(-)-a-amino-p-hydroxybenzylpenicillintrydrate - Category
Authoritative Data Verified Data
B-lactam antibiotics, penicillins.
Last Update：2022-01-01 13:31:37
D-(-)-a-amino-p-hydroxybenzylpenicillintrydrate - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 13:31:37
D-(-)-a-amino-p-hydroxybenzylpenicillintrydrate - Amoxicillin for suspension
Authoritative Data Verified Data
This product contains amoxicillin (according to C16H19N3O5S) should be 90.0% to 120.0% of the label amount.
trait
This product is fine particles or powder; Aromatic.
identification
- take an appropriate amount of this product (about 0.125g equivalent to amoxicillin based on C16H19N3O5S), dissolve and dilute with 4.6% sodium bicarbonate solution to make a solution containing about 10mg of amoxicillin (based on C16H19N305S) per 1 ml, filter, as a test solution; According to the item (1) of the identification under amoxicillin test, the results of the inquiry.
- 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.
- two items (1) and (2) above can be selected as one item.
examination
- acidity: take this product and add water to make a suspension containing 25mg of amoxicillin (according to C16H19N3O5S) per lml, and determine it according to law (General rule 0631). The pH value should be 4.0~7.0.
- 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).
- other than sedimentation volume ratio (single dose packaging), should comply with the relevant provisions under the item of oral suspension (General Principle 0123).
Content determination
take the contents under the difference of loading amount, mix evenly, accurately weigh appropriate amount (about equivalent to amoxicillin, 0.125g according to C16H19N3O5S), add the mobile phase to dissolve and quantitatively dilute to make a solution containing about 0.5mg of amoxicillin (based on CC16H19N3O5S) per 1 ml, filter, and take the continued filtrate as the test solution, according to the method of amoxicillin under the item, that is obtained.
category
Same as amoxicillin.
specification
Based on C16H19N305S (1)0.125g (2)0.25g(3)1.25g (4)2.5g
storage
protected from light and sealed.
Last Update：2022-01-01 13:31:38
D-(-)-a-amino-p-hydroxybenzylpenicillintrydrate - Amoxicillin tablets
Authoritative Data Verified Data
This product contains amoxicillin (according to C16H19N3O5S) should be 90.0% to 110.0% of the label amount.
trait
This product is white or white-like tablets or film-coated tablets, white or white-like after removing the coating.
identification
- take an appropriate amount of fine powder of this product (about 0.125g equivalent to amoxicillin, according to C16H19N3O5S), dissolve and dilute with 4.6% sodium bicarbonate solution to prepare about amoxicillin per 1 mL (according to C16H19N305S) 10mg of the solution was filtered, and the same result was obtained as the test solution under the item (1) of identification under amoxicillin.
- 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.
- two items (1) and (2) above can be selected as one item.
examination
- Related Substances: take an appropriate amount of fine powder of this product, precisely weigh it, add mobile phase A to dissolve and quantitatively dilute it into A solution containing about 2.0mg of amoxicillin (as measured by C16H19N3O5S) per 1 ml, and filter it through, the filtrate was taken and determined according to the method under amoxicillin. The single impurity peak area shall not be greater than the main peak area of the control solution (1.0%), and the sum of each impurity peak area shall not be greater than 5 times (5.0%) of the main peak area of the control solution.
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 second method), water 900ml as the dissolution medium, the speed of 75 rpm, according to the law, after 30 minutes, take the appropriate amount of the solution, filter, take the appropriate amount of the filtrate, and dilute it quantitatively with water to make a solution containing about 130ug of amoxicillin (according to C16H19N3O5S) per 1 ml, according to UV-visible spectrophotometry (General rule 0401), measure absorbance at the wavelength of 272nm; Take another 10 tablets of this product, grind them, weigh an appropriate amount accurately (about equivalent to the average tablet weight), the solution containing about 130ug per 1 ml is prepared by dissolving and quantitatively diluting with water according to the labeled amount, filtered, and the filtrate is taken as a control solution, which is determined by the same method, and the dissolution amount of each tablet is calculated. The limit is 80% and shall be in accordance with the provisions.
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
Take 10 tablets of this product, precision weighing, fine grinding, precision weighing appropriate amount (about equivalent to amoxicillin, 0.125g according to C16H19N3O5S), add the mobile phase to dissolve and quantitatively dilute to make a solution containing about 0.5mg of amoxicillin (based on C16H19N3O5S) per 1 ml, filter, and take the continued filtrate as the test solution, according to the method of amoxicillin under the item, that is obtained.
category
Same as amoxicillin.
specification
Based on C16H19N305S (1)0.125g (2 )0.25g
storage
light shielding, sealed storage.
Last Update：2022-01-01 13:31:39
D-(-)-a-amino-p-hydroxybenzylpenicillintrydrate - AmoxiciUin Capsules
Authoritative Data Verified Data
This product contains amoxicillin (according to C16H19N305S) should be 90.0% to 110.0% of the label amount.
trait
The contents of this product are white to yellow powder or granules.
identification
- take an appropriate amount of the content of this product (about 0.125g equivalent to amoxicillin, according to C16H19N305S), add 4.6% sodium bicarbonate solution to dissolve and dilute to prepare about amoxicillin (according to C16H19N305S) per 1 ml. 10 mg of solution, filtered, as a test solution; According to the identification under the item (1) of amoxicillin test, showed the same results.
- 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.
- two items (1) and (2) above can be selected as one item.
examination
- relevant substances the content of this product is accurately weighed, dissolved and quantitatively diluted with mobile phase A to prepare A solution containing 2.0mg of amoxicillin (calculated) per lml, and filtered, the filtrate was taken and determined according to the method under amoxicillin. The single impurity peak area shall not be greater than the main peak area of the control solution (1.0%), and the sum of each impurity peak area shall not be greater than 5 times (5.0%) of the main peak area of the control solution.
- amoxicillin polymer: take the contents of this product, mix them evenly, weigh an appropriate amount (about 0.2g, equivalent to amoxicillin, according to C16H19N305S) precisely, and place it in a 10ml measuring flask, 5% anhydrous sodium carbonate solution (5ml) was added to dissolve the solution and diluted to the scale with water. The solution was shaken and filtered. The amount of polymer containing amoxicillin should not exceed 0.2% of the labeled amount.
- moisture the contents of this product shall not contain more than 0832 of moisture as determined by the method for moisture determination (General rule 16.0%, Method 1).
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 first method), with water as the dissolution medium, the speed is 100 rpm, according to the law, after 45 minutes, take the appropriate amount of the solution, filter, take the appropriate amount of the filtrate, and dilute it quantitatively with water to prepare a solution containing about 130ug of amoxicillin (based on C16H19N305S) per 1 ml, measure absorbance at 272nm wavelength according to UV-visible spectrophotometry (General rule 0401); Take the content under the item of loading difference separately, mix evenly, accurately weigh an appropriate amount (about equivalent to the average loading), add water to the labeled amount, dissolve and quantitatively dilute to prepare a solution containing about 130ug per lml, filter, and take the continued filtrate as the control solution, the same method was used to calculate the dissolution of each particle. The limit is 80% and shall be in accordance with the provisions.
- others should comply with the relevant provisions under the capsule (General 0103).
Content determination
take the contents under the difference of loading amount, mix evenly, accurately weigh appropriate amount (about equivalent to amoxicillin, 0.125g according to C16H19N305S), add the mobile phase to dissolve and quantitatively dilute to make a solution containing about 0.5mg of amoxicillin (based on C16H19N305S) per 1 ml, filter, and take the continued filtrate as the test solution, according to the method of amoxicillin under the item, that is obtained.
category
Same as amoxicillin.
specification
Based on C16H19N305S (l)0.125g (2)0.25g(3)0.5g
storage
light shielding, sealed storage.
Last Update：2022-01-01 13:31:40
D-(-)-a-amino-p-hydroxybenzylpenicillintrydrate - Amoxicillin granules
Authoritative Data Verified Data
This product contains amoxicillin (according to C16H19N305S) should be 90.0% to 110.0% of the label amount.
trait
This product is granular and powder; Aromatic.
identification
- take an appropriate amount of this product (about 0.125g equivalent to amoxicillin based on C16H19N305S), dissolve and dilute with 4.6% sodium bicarbonate solution to make a solution containing about 10mg of amoxicillin (based on C16H19N305S) per 1 ml, filtration, as a test solution; According to the item (1) of the identification under amoxicillin, the same results are shown.
- 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.
- two items (1) and (2) above can be selected as one item.
examination
- acidity: take this product and add water to make a suspension containing 25mg of amoxicillin (according to C16H19N305S) per lml, and determine it according to law (General rule 0631). The pH value should be 4.0~7.0.
- the weight loss on drying of this product shall be determined by the method specified under the item of granules (General rule 0104), and the weight loss shall not exceed 5.0%.
- solubility: take an appropriate amount of this product (about 1.25g equivalent to amoxicillin, according to C16H19N305S), heat 200ml of water, stir for 5 minutes, dissolve all or slightly turbid, and no foreign matter.
- others should comply with the relevant provisions under The granule (General Principle 0104).
Content determination
take the contents under the difference of loading amount, mix evenly, accurately weigh appropriate amount (about equivalent to amoxicillin, 0.125g according to C16H19N305S), add the mobile phase to dissolve and quantitatively dilute to make a solution containing about 0.5mg of amoxicillin (based on C16H19N305S) per 1 ml, filter, and take the continued filtrate as the test solution, according to the method of amoxicillin under the item, that is obtained.
category
Same as amoxicillin.
specification
Based on C16H19N305S (1)0.125g (2)0.25g(3)1.5g
storage
protected from light and sealed.
Last Update：2022-01-01 13:31:41
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Spot supply
Product Name: Amoxicillin Monomer Visit Supplier Webpage Request for quotationCAS: 26787-78-0
Tel: 0714-3999186
Email: 2853786052@qq.com
Mobile: 86+15671228036
QQ: 2853786052
Wechat: 15671228036
Product Name: Amoxicillin Request for quotation
CAS: 26787-78-0
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: 26787-78-0
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
Spot supply
Product Name: Amoxicillin Visit Supplier Webpage Request for quotationCAS: 26787-78-0
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
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