MM 1415
Clavulanate Potassium
CAS: 61177-45-5
Molecular Formula: C8H10KNO5
MM 1415 - Names and Identifiers
| Name | Clavulanate Potassium |
| Synonyms | MM 1415 Clavulanate CLAVULANTE POTASSIUM Potassium Clavulanat Potassium clavulanate CLAVULANATE POTASSIUM Clavulanate Potassium CLAVULANIC ACID POTASSIUM Clavulanic acid potassium salt CLAVULANIC ACID POTASSIUM SALT potassium (2R,3Z,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate 4-Oxa-1-azabicyclo3.2.0heptane-2-carboxylic acid, 3-(2-hydroxyethylidene)-7-oxo-, monopotassium salt, (2R,3Z,5R)- |
| CAS | 61177-45-5 |
| EINECS | 262-640-9 |
| InChI | InChI=1/C8H9NO5.K/c10-2-1-4-7(8(12)13)9-5(11)3-6(9)14-4;/h1,6-7,10H,2-3H2,(H,12,13);/q;+1/p-1/b4-1-;/t6-,7-;/m1./s1 |
| InChIKey | ABVRVIZBZKUTMK-JSYANWSFSA-M |
MM 1415 - Physico-chemical Properties
| Molecular Formula | C8H10KNO5 |
| Molar Mass | 239.27 |
| Melting Point | >1600C (dec) |
| Boling Point | 545.8°C at 760 mmHg |
| Specific Rotation(α) | +55～+60° |
| Flash Point | 283.9°C |
| Solubility | Soluble in Methanol and Water |
| Vapor Presure | 3.45E-14mmHg at 25°C |
| Appearance | neat |
| Storage Condition | Inert atmosphere,2-8°C |
| MDL | MFCD01710901 |
| Physical and Chemical Properties | Potassium Clavulanate (Clavulanate Potassium) is a new type of β-lactam antibiotics produced by Streptomyces clavularis, also known as Potassium Clavulanate. White or yellowish crystalline powder, odor, easy to wet. Easily soluble in water, soluble in methanol, slightly soluble in ethanol, insoluble in ether. The pH of the 1% aqueous solution is 6.0-8.0. FIG. 1 shows the structural formula of potassium clavulanate. |
| Use | Β-lactamase inhibitors |
MM 1415 - Risk and Safety
| Risk Codes | R11 - Highly Flammable R42/43 - May cause sensitization by inhalation and skin contact. R44 - Risk of explosion if heated under confinement R36 - Irritating to the eyes R14 - Reacts violently with water |
| Safety Description | S8 - Keep container dry. S16 - Keep away from sources of ignition. S22 - Do not breathe dust. S36/37 - Wear suitable protective clothing and gloves. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) S43 - In case of fire use ... (there follows the type of fire-fighting equipment to be used.) S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. |
| UN IDs | UN1325 - class 4.1 - PG 2 - Flammable solids, organic, n.o.s., HI: all |
| WGK Germany | 2 |
| RTECS | RN6802700 |
MM 1415 - Upstream Downstream Industry
| Raw Materials | Starch potato Hydrochloric acid Ethyl Alcohol |
MM 1415 - Standard
Authoritative Data Verified Data
This product is Z)-(2S,5K)-3-(2-hydroxyethyl)-7-oxo-4-oxa-1-azabicyclo [3. 2. 0] Potassium heptane-2-carboxylate. The content of clavulanic acid (C8H9NO5) should be between 81.0% and 85.6%, calculated as anhydrous.
Last Update：2024-01-02 23:10:35
MM 1415 - Trait
Authoritative Data Verified Data
- This product is white to yellowish crystalline powder; Slightly odorous; Easy to wet.
- This product is easily soluble in water, soluble in methanol, slightly soluble in ethanol, insoluble in ether.
specific rotation
take this product, precision weighing, adding water to dissolve and quantitatively dilute to make a solution containing about 10 mg per lml, and determine according to law (General rule 0621). The specific rotation is 55 ° to 60 °.
Last Update：2022-01-01 11:55:26
MM 1415 - Differential diagnosis
Authoritative Data Verified Data
- 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 950).
- the product of the aqueous solution of potassium salt identification (2) of the reaction (General 0301).
Last Update：2022-01-01 11:55:26
MM 1415 - Exam
Authoritative Data Verified Data
pH
take 0.2g of this product, add 20ml of water to dissolve, and then measure it according to law (General rule 0631). The pH value should be 6.0~8.0.
absorbance
take this product 50mg, precision weighing, 50ml flask, add pH7.0 0.1 mol/L phosphate buffer solution (weigh 1.361g of potassium dihydrogen phosphate, put it in a 35% measuring flask, add water to dissolve and dilute to the scale, adjust the pH value to 7.0 with sodium hydroxide solution) dissolve and dilute to the scale, shake, according to UV-visible spectrophotometry (General rule 0401), at the wavelength of 278nm immediately measured, absorbance should not exceed 0.40.
Related substances
take an appropriate amount of this product, add mobile phase A to dissolve and dilute to prepare A solution containing about 8mg of clavulanic acid per lml as A test solution; Take an appropriate amount for precision measurement, A solution containing about 0.08mg of clavulanic acid per 1 ml was prepared as A control solution by quantitative dilution with mobile phase A. According to the determination by HPLC (General 0512), silica gel bonded with eighteen alkyl silane is used as the filler; The mobile phase A is 0.05mol/L sodium dihydrogen phosphate solution (the pH value is adjusted to 4.0 with phosphoric acid); the mobile phase B was 0.05mol/L sodium dihydrogen phosphate solution (adjusted to pH 4.0 with phosphoric acid)-methanol (50:50); The column temperature was 40 ° C; the detection wavelength was 230nm. Take appropriate amount of amoxicillin and clavulanic acid, add mobile phase A to dissolve and dilute to make A mixed solution containing about 2mg of each lml, take 20u1 to inject human liquid chromatograph, record chromatogram, the relative retention time of clavulanic acid peak and amoxicillin peak were about 1.0 and 2.5, respectively, and the separation degree between clavulanic acid peak and amoxicillin peak should be greater than 13. Immediately take 20 u1 of the test solution and the control solution, respectively inject into the liquid chromatograph, record the chromatogram, if there are impurity peaks in the chromatogram of the 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 2 times the main peak area of the control solution (2.0% ) , 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.
residual solvent
take about 0.2g of this product, precision weighing, set in the top empty bottle, precision plus sodium chloride 0.5g, Precision Plus 1 mol/L sodium hydroxide solution 2ml, sealed, as a test solution; accurately weigh the appropriate amount of acetone, isopropyl alcohol, toluene and n-butanol respectively, and quantitatively dilute with lmol/L sodium hydroxide solution to prepare their respective stock solutions, and accurately take the appropriate amount respectively, quantitatively dilute with 1 mol/L sodium hydroxide solution to make a mixed solution containing about 0.5mg of acetone, 0.5mg of isopropanol, 0.089mg of toluene and 0.5mg of n-butanol in each 1 ml, and take 2ml with precision, top empty bottle, precision plus sodium chloride 0.5g, sealed, as a reference solution. According to the test for determination of residual solvents (General rule 0861, second method), the capillary column with Nitro-terephthalic acid-modified polyethylene glycol (or similar polarity) as stationary liquid was used as the chromatographic column, and the initial temperature was 60°C, and it was maintained for 10 minutes, then the temperature was increased to 120°C at a rate of 20°C per minute for 8 minutes; The inlet temperature was 150°C; The detector temperature was 250°C; The equilibrium temperature of the headspace bottle was 80°C, the equilibrium time was 30 minutes, and the control solution was injected in headspace, Record the chromatogram, acetone, isopropanol, toluene and n-butanol peaks in turn, the separation degree between the main peaks should meet the requirements. The test solution and the reference solution were injected into the headspace, and the chromatogram was recorded. The residual amounts of acetone, isopropanol, toluene and n-butanol were calculated by the peak area according to the external standard method.
2-ethylhexanoic acid
take this product, determination according to law (General Principles 0873), not over 0.8%.
moisture
take this product, according to the moisture determination method (General 0832 first method 1), the water content shall not exceed 0.5%.
Heavy metals
take 0.2g of this product, add 23ml of water to dissolve, add 2ml of acetate buffer (pH 3.5), and check according to law (the first method of general rule 0821), containing no more than 20 parts per million of heavy metals.
visible foreign body
take 5 parts of this product, each 0.2g, plus particle inspection water dissolution, inspection according to law (General 0904), should comply with the provisions. (For aseptic dispensing)
insoluble particles
Take 3 parts of this product, and add the particle inspection water to make a solution containing 60mg per 1 ml, and check according to law (General rule 0903), no more than 6000 particles of 10um and lOum in each lg sample, and no more than 600 particles of 25um and 25um in each sample. (For aseptic dispensing)
bacterial endotoxin
take this product, check according to law (General rule 1143), the amount of endotoxin in clavulanic acid per 1 mg should be less than 0.030EU. (For injection)
sterile
take this product, dissolve and dilute with appropriate solvent, after membrane filtration treatment, inspection according to law (General rule 1101), should comply with the provisions. (For aseptic dispensing)
Last Update：2022-01-01 11:55:28
MM 1415 - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel was bonded with octa-alkyl silane as filler; Phosphate buffer solution (7.8g of sodium dihydrogen phosphate, about 900ml of water was added to dissolve, and the pH value was adjusted to 4.4 with dilute phosphoric acid or 10 mol/L sodium hydroxide solution, diluted with water to 1000ml)-acetonitrile (95:5) as mobile phase, the detection wavelength was 220mn. Take appropriate amount of clavulanic acid reference and amoxicillin reference, add water to dissolve and dilute to make a mixed solution containing about 0.45mg of clavulanic acid and amoxicillin (as calculated by C16H19N3O5S) per 1 ml, 20u1 injection human liquid chromatography, record chromatogram, clavulanic acid peak and amoxicillin peak separation degree should be greater than 3.5.
assay
take about 25mg of this product, accurately weigh it, put it in a 100ml measuring flask, add water to dissolve and dilute to the scale, shake well, as a test solution, immediately take 20 u1, note human liquid chromatograph, record chromatogram, take appropriate amount of clavulanic acid reference substance, determine with the same method, calculate the content of C8H9N05 in the test article by peak area according to external standard method.
Last Update：2022-01-01 11:55:28
MM 1415 - Category
Authoritative Data Verified Data
B-lactamase inhibitors.
Last Update：2022-01-01 11:55:29
MM 1415 - Storage
Authoritative Data Verified Data
sealed and stored in a dry place below 20°C.
Last Update：2022-01-01 11:55:29
MM 1415 - Amoxicillin and clavulanate potassium for suspension
Authoritative Data Verified Data
This product is a mixed preparation of amoxicillin and clavulanate potassium [the ratio of the amount of amoxicillin (as measured by C16H19N3O5S) and clavulanic acid (C8H9NO5) is 4:1 or 7:1 or 14:1, containing amoxicillin (based on C16H19N3O5S) should be 90.0% ~ 120.0% of the label amount, containing clavulanic acid (C8H9NO5) should be 90.0% ~ 125.0% of the label amount.
trait
This product is white to light yellow powder or fine particles; Gas fragrance.
identification
- take 1 pack of this product, if necessary, dilute, add pH 7.0 phosphate buffer solution (if necessary, ice bath ultrasound for 10~15 minutes) and make a solution containing about 5mg of amoxicillin (based on C16H19N305S) per 1 ml, filter, and take the continued filtrate as the test solution; Take the appropriate amount of amoxicillin reference and clavulanic acid reference, add pH 7.0 phosphate buffer solution (if necessary, ice bath ultrasound for 10~15 minutes to help dissolve, in which clavulanic acid is to be added after ultrasound) made into lml containing acini (according to C16H19N3O5S) A solution of 5mg each of clavulanic acid and clavulanic acid was used as a reference solution, add pH 7.0 phosphate buffer solution (if necessary, ultrasound in ice bath for 10~15 minutes to assist dissolution, in which clavulanic acid is added after Ultrasound) and dilute to make amoxicillin (according to C16H19N3O5S) per lml, A mixed solution of 5mg each of clavulanic acid and cefaclor was used as the system suitability solution. According to the thin layer chromatography (General 0502) test, draw 2ul of each of the above three solutions, respectively, on the same silica gel GF254 thin layer plate, with ethyl acetate-ether-two gas methane-formic acid (5:4:5:4) for the development of the agent, expand, dry, set the UV light (365mn) under the inspection. The system suitability solution should show three discrete spots; The position and fluorescence of the main spot displayed by the test solution should be the same as the position and fluorescence of the main spot of the control solution.
- in the chromatogram recorded under the content determination item, the retention time of the two main peaks of the test solution should be consistent with the retention time of the two main peaks of the control 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, add mobile phase A to dissolve (if necessary, ice bath ultrasound for 5-10 minutes to assist dissolution) and dilute it to prepare about amoxicillin per lml (based on C16H19N3O5S) 2mg of the solution is filtered, and the filtrate is taken as the test solution; The appropriate amount is taken with precision, and the solution containing amoxicillin (according to C16H19N305S) 4ug per lml is made by quantitative dilution with mobile phase A, as a control solution. Silica gel bonded with eighteen alkyl Silanes (Type A) was used as filler as determined by high performance liquid chromatography (General rule 0512); mobile phase A was 0.01mol/L potassium dihydrogen phosphate solution (adjusted to pH 6.0 with 2mol/L sodium hydroxide solution), the mobile phase B was 0.01mol/L potassium dihydrogen phosphate solution (adjusted to pH 6.0 with 2mol/L sodium hydroxide solution)-acetonitrile (20:80); The detection wavelength was 230mn; first, the mobile phase A- mobile phase B(98:2) was eluted isocratically, and immediately after the elution of amoxicillin was completed, the linear gradient elution was carried out according to the following table. The retention time of amoxicillin peak is about 10 minutes. The amoxycillin/clavulanic acid system suitability control is dissolved and diluted with mobile phase A to make A solution containing about 2.5mg per 1 ml, the recorded chromatograms should be consistent with the standard chromatograms. Accurately take 20ul of the test solution and the control solution, respectively, and inject the human liquid chromatograph to record the chromatogram. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than 1.25 times (2.5%) of the sum of the two main peaks of the control solution, the sum of each impurity peak area shall not be greater than 3.5 times (7.0%) of the sum of the two main peak areas of the control solution, and the peaks smaller than the two main peak areas and 0.05 times in the chromatogram of the test solution shall be ignored.
- the moisture content of this product shall not exceed 0832 (the specification is C16H19N3O5S 0.25g or less) as determined by moisture determination method (General rule 5.0%, first method 1). Or not over 7.0% (specification for C16H19N305S 0.6g).
- Content uniformity: Take 10 packs of this product, put them in 500ml measuring flasks respectively, dissolve them by ultrasound with appropriate amount of water, dilute them with water to the scale, shake them well, filter them, and take appropriate amount of filtrate with precise volume, A solution containing 0.04mg of clavulanic acid per 1 ml was prepared by quantitative dilution with water. Determination of the content of clavulanic acid according to the chromatographic conditions under the content determination item shall comply with the regulations (General rule 0941). (14:1 specification)
- 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, the appropriate amount of the solution was filtered, and the continued filtrate was taken as the test solution, water was added to dissolve and quantitatively dilute to prepare a mixed solution having the same concentration as the test solution as a reference solution. The dissolution amounts of amoxicillin (in terms of C16H19N3O5S) and clavulanic acid in each pack were calculated respectively as determined under the item of content determination. The limit shall be 80% of the labeled amount and shall be in accordance with the regulations.
- loading quantity difference: the loading quantity difference of granules (General rule 0104) shall be checked, and the requirements shall be met.
- other than sedimentation volume ratio (single dose package), should comply with the relevant provisions under the item of oral suspension (General Principle 0123).
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; 0.05mol/L sodium dihydrogen phosphate solution (take sodium dihydrogen phosphate 7.8g and water 900ml to dissolve, the pH value was adjusted to 10% ± 4.4 with 0.1 phosphoric acid solution or sodium hydroxide solution, diluted with water to ML)-methanol (95:5) as mobile phase; The detection wavelength was 220mn. The amoxycillin clavulanic acid system applicable reference substance is taken, dissolved and diluted with mobile phase to make a solution containing 0.8mg per 1 ml, and 20u1 is injected into the human Liquid Chromatograph. The chromatogram recorded should be consistent with the standard chromatogram.
- determination of this product 10 packs, precision weighing, fine grinding, precision weighing take the right amount (about equivalent to the average amount), add the right amount of water, sonicate and quantitatively dilute to make amoxicillin (as measured by c16h19n3o5 s) in about 0 ml. 5M g of the solution is filtered and used as the test solution, and the filtrate 20u1 is injected into the human liquid chromatograph immediately, and the chromatogram is recorded; in addition, the appropriate amounts of the amoxicillin reference substance and the clavulanic acid reference substance were accurately weighed, respectively, added with water to dissolve and quantitatively diluted to prepare a mixed solution having the same concentration as the test solution, which was used as the reference solution and determined by the same method. According to the external standard method, the contents of C16H19N305S and C8H9N05 in the sample were calculated by peak area.
category
beta-lactam antibiotics, penicillins.
specification
- ① 0.15625g(C16H19N305S 0.125g and C8H9N05 0.03125g)② 0.3125g(C16H19N3O5S 0.25g and C8H9N05 0.0625g)
- 0.2285g(C16H19N3O5S 0.2g and C8H9NO5 0.0285g)
- 0.643g(C16H19N3O5S 0.6g and C8H9N05 0.043g)
storage
sealed and stored in a cool dark dry place.
Last Update：2022-01-01 11:55:30
MM 1415 - Amoxicillin and clavulanate potassium tablets
Authoritative Data Verified Data
This product is a mixed preparation of amoxicillin and clavulanate potassium [the ratio of the amount of amoxicillin (according to C16H19N3O5S) and clavulanic acid (C8H9NO5) is 2:1 or 4:1 or 7:1 ] , containing amoxicillin (according to C16H19N3O5S) and clavulanic acid (C8H9N05) should be 90.0% ~ 120.0% of the label amount.
trait
This product is a film-coated tablet, white to light yellow after removing the coating.
identification
- take 1 tablet of this product, grind it, add pH 7.0 phosphate buffer solution (if necessary, ice bath ultrasound for 10~15 minutes) and make it to contain about amoxicillin per lml (according to C16H19N3O5S) 5mg of the solution was filtered, and the continued filtrate was taken as the test solution, add pH 7.0 phosphate buffer solution (if necessary, ultrasound in ice bath for 10~15 minutes to help dissolve, in which clavulanic acid is added after Ultrasound) and dilute to prepare amoxicillin (according to C16H19N3O5S) in about 1 ml. A solution of 5mg and 2mg of clavulanic acid was used as the control solution, add pH7.0 phosphate buffer solution (if necessary, ice bath ultrasound for 10~15 minutes to help dissolve, in which clavulanic acid to be added after the sound) and diluted to make each lml respectively containing amoxicillin (according to C16H19N305S) clavulanic Acid and cefaclor, about 5mg each, as a system-suitable solution. According to thin layer chromatography (General 0502) test, absorb 2ul of each of the above three solutions, respectively point on the same silica gel GF2S4 thin On the plate, ethyl acetate-ethyl ether-dioxymethane-formic acid (5:4:5:4) was used as a developing solvent, developed, dried, and examined under a UV lamp (365nm). The system suitability solution should show three discrete spots-the position and fluorescence of the dominant spot displayed by the test solution should be the same as the position and fluorescence of the dominant spot of the control solution.
- in the chromatogram recorded under the content determination item, the retention time of the two main peaks of the test solution should be consistent with the retention time of the two main peaks of the control 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, add mobile phase A to dissolve (if necessary, ice bath ultrasound for 5-10 minutes to assist dissolution) and dilute it to prepare about amoxicillin per lml (based on C16H19N3O5S) 2mg of the solution is filtered, and the continued filtrate is taken as the test solution; The appropriate amount is taken with precise amount, and the solution containing amoxicillin (according to C16H19N3O5S) 40ug per lml is made by quantitative dilution with mobile phase A, as a control solution. Silica gel bonded with eighteen alkyl silane (Type A) was used as filler as determined by high performance liquid chromatography (General 0512); Mobile phase A was 0.Olmol/L potassium dihydrogen phosphate solution (adjusted to pH 6.0 with 2mol/L sodium hydroxide solution), mobile phase B 0.Olmol/L potassium dihydrogen phosphate solution (adjusted to pH 6.0 with 2mol/L sodium hydroxide solution)-acetonitrile (20:80); Detection wavelength was 230mn; Mobile phase A- mobile phase B(98:2) isocratic elution, immediately after completion of amoxicillin elution, perform linear gradient elution according to the following table. The retention time of amoxicillin peak is about 10 minutes. The amoxycillin/clavulanic acid system suitability control is dissolved and diluted with mobile phase A to make A solution containing about 2.5mg per 1 ml, the recorded chromatograms should be consistent with the standard chromatograms. Accurately take 20ul of the test solution and the control solution, respectively, and inject the human liquid chromatograph to record the chromatogram. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than 1.25 times (2.5%) of the sum of the two main peaks of the control solution, the sum of each impurity peak area shall not be greater than 3.5 times (7.0%) of the sum of the two main peak areas of the control solution, and the peaks smaller than the two main peak areas and 0.05 times in the chromatogram of the test solution shall be ignored.
- moisture take this product, ground, according to the determination of moisture (General rule 0832 first method 1), water content shall not exceed 7.5% (specification is containing C16H19N3O5S 0.25g or less than 0.25g) or not over 10.0% (specification contains C16H19N3O5S greater than 0.25g to 0.5g) or not over 11.0% (specification contains C16H19N30S greater than 0.5g).
- 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, the appropriate amount of the solution was filtered, and the continued filtrate was taken as the test solution, water was added to dissolve and quantitatively dilute to prepare a mixed solution having the same concentration as the test solution as a reference solution. The dissolution amounts of amoxicillin (in terms of C16H19N3O5S) and clavulanic acid in each tablet were calculated respectively as determined under the item of content determination. The limit shall be 80% of the labeled amount and shall be in accordance with the regulations.
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
- measured by high performance liquid chromatography (General 0512).
- color test conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; 0.05mol/L sodium dihydrogen phosphate solution (take 7.8g of sodium dihydrogen phosphate, add water 900ml to dissolve, the pH value was adjusted to 10% ± 4.4 with 0.1 phosphoric acid solution or sodium hydroxide solution, diluted with water to ML)-methanol (95:5) as mobile phase; The detection wavelength was 220nm. The amoxycillin-clavulanic acid system applicable reference substance is taken, dissolved by adding mobile phase and diluted to make a solution containing about 0.8mg per 1 ml, and 20u1 is injected into human Liquid Chromatograph. The chromatogram recorded should be consistent with the standard chromatogram.
- determination of 10 tablets of this product, precision weighing, fine grinding, precision weighing to take an appropriate amount (about equivalent to the average tablet weight), add an appropriate amount of water, ultrasonically dissolve and quantitatively dilute a solution containing about 0.5mg of amoxicillin (as calculated by C16H19N3O5S) per 1 ml, which is filtered and used as a test solution, immediately, 20ul of the filtrate was accurately weighed and injected into human liquid chromatograph, and the chromatogram was recorded, water was added to dissolve and quantitatively dilute to prepare a mixed solution having the same concentration as the test solution, which was used as a reference solution and was measured by the same method. According to the external standard method, the contents of c16h19n3o5 S and C8H9NO5 in the sample were calculated by peak area.
category
beta-lactam antibiotics, penicillins.
specification
- 0.375g(C16H19N3O5S 0.25g and C8H9N05 0.125g)
- ① 0.625g(C16H19N305S 0.5g and C8H9N05 0.125g) 0.3125g(C16Hl9N305S 0.25g and C8H9N05 0.0625g)
- ① 0.457g(C16H19N3O5S 0.4g and C8H9NO5 0.057g)② 1.0g(C16H19N3O5S 0.875g and C8H9N05 0.125g)
storage
sealed and stored in a cool dark dry place.
Last Update：2022-01-01 11:55:31
MM 1415 - Amoxicillin and Clavulanate Potassium Dispersible Tablets
Authoritative Data Verified Data
This product is a mixed preparation of amoxicillin and clavulanate potassium [the ratio of the amount of amoxicillin (as measured by C16H19N3O5S) and clavulanic acid (C8H9N05) is 4:1 or 7:1], the contents of amoxicillin (calculated as C16H19N3O5S) and clavulanic acid (C8H9N05) shall be 90.0% to 120.0% of the labeled amount.
trait
This product is white-like to light yellow tablets or film-coated tablets, white to light yellow after removing the coating.
identification
- take 1 tablet of this product, grind, add pH 7.0 phosphate buffer solution (if necessary, ice bath ultrasound for 10 minutes to help dissolve) and make it contain about amoxicillin (according to C16H19N3O5S) per lml. 5mg of the solution was filtered, and the continued filtrate was taken as the test solution, add pH 7.0 phosphate buffer solution (if necessary, ice bath ultrasound for 10 minutes to help dissolve, in which clavulanic acid is added after Ultrasound) and dilute to prepare about amoxicillin per 1 mL (according to C16H19N3O5S) A solution of 5mg and 2mg of clavulanic acid was used as a reference solution; In addition, amoxicillin control, clavulanic acid control and cefaclor control, add pH 7.0 phosphate buffer solution (if necessary, ice bath ultrasound for 10 minutes to help dissolve, in which clavulanic acid to be ultrasonic after adding people) and diluted to make each lml containing amoxicillin (according to C16H19N3O5S), clavulanic Acid and cefaclor are each about 5mg in solution as a system-suitable solution. According to the thin layer chromatography (General 0502) test, absorb the above three solutions each 2 u1, respectively, on the same silica gel GF254 thin layer plate, with ethyl acetate-ether-dichloromethane-formic acid (5:4:5:4) for the development of the agent, expand, dry, set the UV light (365mn) under the inspection. System applicability the solution should show three clearly separated spots; The position and fluorescence of the main spot displayed by the test solution should be the same as the position and fluorescence of the main spot of the control solution.
- in the chromatogram recorded under the content determination item, the retention time of the two main peaks of the test solution should be consistent with the retention time of the two main peaks of the control 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, add mobile phase A to dissolve (if necessary, ice bath ultrasound for 5-10 minutes to assist dissolution) and dilute it to prepare about amoxicillin per lml (based on C16H19N3O5S) 2mg of the solution is filtered, and the filtrate is taken as the test solution; The appropriate amount is taken with precision, and the solution containing about 40ug of amoxicillin (according to C16H19N305S) per lml is made by quantitative dilution with mobile phase A, as a control solution. Silica gel bonded with eighteen alkyl silane (Type A) was used as filler as determined by high performance liquid chromatography (General 0512); Mobile phase A was 0.Olmol/L potassium dihydrogen phosphate solution (adjusted to pH 6.0 with 2mol/L sodium hydroxide solution), mobile phase B was 0.01 mol/L potassium dihydrogen phosphate solution (adjusted to pH 6.0 with 2mol/L sodium hydroxide solution)-Acetonitrile (20:80); The detection wavelength was 230MM. First, mobile phase A- mobile phase B(98:2) was eluted Isocratic, immediately after the completion of the elution of amoxicillin, the linear gradient elution was carried out according to the following table. The retention time of amoxicillin peak is about 10 minutes. The amoxycillin/clavulanic acid system suitability control is dissolved and diluted with mobile phase A to make A solution containing about 2.5mg per 1 ml, the recorded chromatograms should be consistent with the standard chromatograms. 20 u1 of the test solution and the control solution were respectively injected into the liquid chromatograph, and the chromatograms were recorded. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than 1.25 times (2.5%) of the sum of the two main peaks of the control solution, the sum of each impurity peak area shall not be greater than 3.5 times (7.0%) of the sum of the two main peak areas of the control solution, and the peaks smaller than the two main peak areas and 0.05 times in the chromatogram of the test solution shall be ignored.
- moisture take this product, ground fine, according to the determination of moisture (General rule 0832 first method 1), containing no more than 7.0% moisture (specification contains C16H19N3O5S 0.125g) or not over 9.0% (specification for C16H19N3O5S 0.2g to 0.4g).
- 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 15 minutes, the appropriate amount of the solution was filtered, and the filtrate was taken as the test solution, water was added to dissolve and quantitatively dilute to prepare a mixed solution having the same concentration as the test solution as a reference solution. The dissolution amounts of amoxicillin (in terms of C16H19N3O5S) and clavulanic acid in each tablet were calculated respectively as determined under the item of content determination. The limit shall be 80% of the labeled amount and shall be in accordance with the regulations.
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
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; 0.05 mol / L sodium dihydrogen phosphate solution (take sodium dihydrogen phosphate 7 8G, add water 900ml to dissolve, the pH value was adjusted to 10% ± 4.4 with 0.1 phosphoric acid solution or sodium hydroxide solution, diluted with water to ML)-methanol (95:5) as mobile phase; The detection wavelength was 220nm. The amoxycillin-clavulanic acid system applicable reference substance is taken, dissolved and diluted with mobile phase to make a solution containing 0.8mg per 1 ml, and 20ul is injected into the human Liquid Chromatograph. The chromatogram recorded should be consistent with the standard chromatogram.
- determination of 10 tablets of this product, precision weighing, fine grinding, precision weighing to take an appropriate amount (about equivalent to the average tablet weight), add an appropriate amount of water, ultrasonically dissolve and quantitatively dilute a solution containing about 0.5mg of amoxicillin (as calculated by C16H19N3O5S) per 1 ml, which is filtered and used as a test solution, the filtrate 20u1 was immediately accurately weighed and human liquid chromatograph was injected. The chromatogram was recorded, water was added to dissolve and quantitatively dilute to prepare a mixed solution having the same concentration as the test solution, which was used as a reference solution and was measured by the same method. According to the external standard method, the contents of c16h19n3o5 S and C8H3NO5 in the sample were calculated by peak area.
category
tablets of lactam antibiotics, penicillins.
specification
- 0.15625g ( C16H19N3O5S 0.125g and C8H9NO5 0.03125g)
- ① 0.2285g ( C16H19N3O5S 0.2g and C8H9N0 50.0285g)0.457g(C16H19N305S 0.4g and C8H9N05 0.057g)
storage
sealed and stored in a cool dark dry place.
Last Update：2022-01-01 11:55:33
MM 1415 - Amoxicillin and clavulanate potassium granules
Authoritative Data Verified Data
This product is a mixed preparation of amoxicillin and clavulanate potassium [the ratio of the amount of amoxicillin (as measured by C16H19N3O5S) and clavulanic acid (C8H9N05) is 1:1 or 4:1 or 7:1], containing amoxicillin (based on C16H19N3O5S) shall be 90.0% to 110.0% of the label amount, and containing clavulanic acid (C8H9N05) shall be 90.0% to 120.0% of the label amount.
trait
This product is white to light yellow particles or suspended particles or fine particles; Gas fragrance.
identification
- take 1 pack of this product, if necessary, dilute, add pH 7.0 phosphate buffer solution (if necessary, ice bath ultrasound for 10~15 minutes) and make a solution containing about 5mg of amoxicillin (based on C16H19N3O5S) per 1 ml, filter, and take the continued filtrate as the test solution; Take the appropriate amount of amoxicillin reference and clavulanic acid reference, add pH 7.0 phosphate buffer solution (if necessary, ultrasound in ice bath for 10~15 minutes to help dissolve, in which clavulanic acid is added after Ultrasound) and dilute to make amoxicillin per lml (according to C16H19N305S) A solution of 5mg each of clavulanic acid and clavulanic acid was used as a reference solution, add pH 7.0 phosphate buffer solution (if necessary, ultrasound in ice bath for 10~15 minutes to assist dissolution, in which clavulanic acid is added after Ultrasound) and dilute to make amoxicillin (according to C16H19N3O5S) per lml, A solution of 5mg each of clavulanic acid and cefaclor, as a system-suitable solution. According to the thin layer chromatography (General 0502) test, absorb the above three solutions each 2 u1, respectively, on the same silica gel GF 254 thin layer plate, with ethyl acetate-ether-methylene chloride-formic acid (5:4:5:4) for the development of the agent, expand, dry, set the UV light (365mn) under the inspection. System applicability the solution should show three clearly separated spots; The position and fluorescence of the main spot displayed by the test solution should be the same as the position and fluorescence of the main spot of the control solution.
- in the chromatogram recorded under the content determination item, the retention time of the two main peaks of the test solution should be the same as the retention time of the two main peaks of the control solution.
- two items (1) and (2) above can be selected as one item.
examination
- acidity: take this product, add water to make a uniform suspension containing about 25mg of amoxicillin (according to C16H19N3O5S) per lml, and determine it according to law (General rule 0631). The pH value should be 4.5~7.0.
- Related substances take an appropriate amount of fine powder of this product, add mobile phase A to dissolve (if necessary, ice bath ultrasound for 5-10 minutes to assist dissolution) and dilute it to prepare about amoxicillin per lml (based on C16H19N305S) 2mg of the solution was filtered, and the filtrate was taken as the test solution; The appropriate amount was taken with precision and diluted quantitatively with mobile phase A to prepare A solution containing about 40ug of amoxicillin (according to C16H19N305S) per lml, as a control solution. According to the determination of high performance liquid chromatography (General 0512), using eighteen alkyl silane bonded silica gel (Type A) as filler; Mobile phase A is O.Olmol/L potassium dihydrogen phosphate solution (adjusted to pH 6.0 with 2mol/L sodium hydroxide solution), mobile phase B was 0.01mol/L potassium dihydrogen phosphate solution (adjusted to pH 6.0 with 2mol/L sodium hydroxide solution)-Acetonitrile (20:80 ); The detection wavelength was 230mn; First, mobile phase A- mobile phase B(98:2) was eluted Isocratic, immediately after the completion of the elution of amoxicillin, the linear gradient elution was carried out according to the following table. The retention time of amoxicillin peak is about 10 minutes, and the amoxycillin clavulanic acid system suitability control is taken, and the mobile phase A is added to dissolve and dilute to make A solution containing about 2.5mg per 1 ml, and 20u1 is injected into the liquid chromatograph, the recorded chromatograms should be consistent with the standard chromatograms. Accurately take 20ul of the test solution and the control solution, respectively, and inject the human liquid chromatograph to record the chromatogram. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than 1.25 times (2.5%) of the sum of the two main peaks of the control solution, the sum of each impurity peak area shall not be greater than 3.5 times (7.0%) of the sum of the two main peak areas of the control solution, and the peaks smaller than the two main peak areas and 0.05 times in the chromatogram of the test solution shall be ignored.
- moisture take this product, ground fine, according to the determination of moisture (General rule 0832 first method 1), containing no more than 2.0% moisture (specification contains C16H19N3O5S 0.125g) or shall not exceed 5.0% (with the specification of C16H19N305S 0.2g or more).
- particle size take this product, according to the particle size and particle size distribution determination method [General 0982 second method (2)] inspection, should comply with the provisions. The sum of the failure to pass No. 5 sieve and the ability to pass No. 9 sieve in the fine granules shall not exceed 10.0% of the test quantity.
- others should comply with the relevant provisions under The granule (General Principle 0104).
Content determination
- determination by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; 0.05mol/L sodium dihydrogen phosphate solution (take 7.8g of sodium dihydrogen phosphate, add water 900ml to dissolve, the pH value was adjusted to 10% ± 4.4 with 0.1 phosphoric acid solution or sodium hydroxide solution, and diluted with water to looml)-methanol (95:5) as mobile phase; The detection wavelength was 220mn. The amoxycillin-clavulanic acid system suitability control was dissolved and diluted with mobile phase to make a solution containing about 0.8mg per 1 ml. 20ul was injected into the liquid chromatograph, and the chromatogram recorded should be consistent with the standard chromatogram.
- determination of content under the item of loading difference, fine, precision weighing appropriate amount (about equivalent to the average loading), add appropriate amount of water, the solution containing about 0.5mg of amoxicillin (based on C16H19N305S) per 1 ml was prepared by ultrasonic dissolution and quantitative dilution, filtered and used as the test solution. The continuous filtrate 20 u1 was accurately measured immediately, note human liquid chromatograph, record chromatogram; Accurately weigh the appropriate amount of amoxicillin reference and clavulanic acid reference, add water to dissolve and quantitatively dilute to make mixed solution with the same concentration as the test solution, as a control solution, the same method. According to the external standard method, the contents of c16h19n3o5 S and C8H9NO5 in the sample were calculated by peak area.
category
lactam antibiotics, penicillins.
specification
- 0.15625g(C16H19N305S 0.125g and C8H9N05 0.03125g)
- 0.2285g(C16H19N305S 0.2g and C8H9N05 0.0285g)
- 0.375g(C15H19N305S 0.25g and C8H9N05 0.125g)
storage
seal, store in cool, dark and dry place ^
Last Update：2022-01-01 11:55:34
MM 1415 - Amoxicillin Sodium and Clavulanate Potassium for Injection
Authoritative Data Verified Data
This product is a sterile powder prepared by uniformly mixing Amoxicillin Sodium with clavulanate potassium [the ratio of the labeled amount of amoxicillin (as measured by C16H19N305S) and clavulanic acid (C8H9N05) is 5:1]. The content of amoxicillin (based on C16H19N3O5S) and clavulanic acid (C8H9NO5) per 1 mg, calculated as anhydrous, shall not be less than 660ug and 132ug respectively; Calculated as average loading, containing amoxicillin (according to C16H19N3O5S) and clavulanic acid (C8H9NO5) should be 90.0% ~ 110.0% of the standard capacity.
trait
This product is white or off-white powder.
identification
- take 1 bottle of this product, add pH 7.0 phosphate buffer solution and make a solution containing about 10 mg of amoxicillin (according to C16Hl9N305S) per 1 ml, as a test solution; take the appropriate amount of amoxicillin control and Clavulanic Acid Control, add pH 7.0 phosphate buffer solution (if necessary, ultrasound in ice bath for 10~15 minutes to help dissolution, wherein clavulanic acid is added after ultrasound) A solution containing about 10 mg of amoxicillin (based on C16H19N305S) and 2mg of clavulanic acid per 1 ml was prepared as a reference solution, add pH 7.0 phosphate buffer solution (if necessary, ultrasound in ice bath for 10~15 minutes to help solubilization, in which clavulanic acid is added after Ultrasound) and dilute to make amoxicillin per lml (according to C16H19N305S), clavulanic Acid and cefaclor, about 5mg each solution, as the system applicable solution, according to thin layer chromatography (General 0502) test, draw 2ul of each of the above three solutions, on the same silica gel GF2S4 thin layer plate, with ethyl acetate-ether-dichloromethane-formic acid (5:4:5:4) Open, spread, dry, and put under UV light (365mn). System applicability the solution should show three clearly separated spots; The position and fluorescence of the main spot displayed by the test solution should be the same as the position and fluorescence of the main spot of the control solution.
- in the chromatogram recorded under the content determination item, the retention time of the two main peaks of the test solution should be consistent with the retention time of the two main peaks of the control solution.
- two items (1) and (2) above can be selected as one item.
examination
- alkalinity: take this product, add water to make a solution containing about 0.lg per lml, and determine it according to law (General rule 0631). The pH value should be 8.0~10.0.
- the clarity and color of the solution take 5 bottles of this product, and add water according to the marked amount to make a solution containing 50mg of amoxicillin (according to C16H19N305S) per lml, and the solution should be clear and colorless; if it is turbid, it should not be more concentrated than #2 Turbidity standard solution (General rule 0902 method 1); If it is colored, it should be more concentrated than 6# yellow or yellow-green standard colorimetric solution (General rule 0901 method 1), none of them should be deeper.
- the contents of the related substances under the item of loading amount difference are mixed evenly, and the appropriate children are accurately weighed and dissolved by adding mobile phase A and diluted to prepare about amoxicillin per lml (based on C16H19N305S) 2mg of the solution was used as the test solution; An appropriate amount was taken in A precise amount, and the mobile phase A was added for quantitative dilution to prepare A solution containing about 40ug of amoxicillin (in terms of C16H19N3O5S) per 1 ml as A control solution. Silica gel bonded with eighteen alkyl silane (Type A) was used as filler, as determined by high performance liquid chromatography (General rule 0512); Mobile phase A was 0.Olmol/L potassium dihydrogen phosphate solution (adjusted to pH 6.0 with 2mol/L sodium hydroxide solution), mobile phase B 0.Olmol/L potassium dihydrogen phosphate solution (adjusted to pH 6.0 with 2mol/L sodium hydroxide solution)-acetonitrile (20:80); Detection wavelength was 230mn; Mobile phase A- mobile phase B(98:2) isocratic elution, immediately after completion of amoxicillin elution, perform linear gradient elution according to the following table. The retention time of amoxicillin peak is about 10 minutes. The amoxycillin/clavulanic acid system suitability control is dissolved and diluted with mobile phase A to make A solution containing about 2.5mg per 1 ml, the recorded chromatograms should be consistent with the standard chromatograms. 20ul of the test solution and the control solution were respectively injected into the liquid chromatograph, and the chromatograms were recorded. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than 1.25 times (2.5%) of the sum of the two main peaks of the control solution, the sum of each impurity peak area shall not be greater than 3.5 times (7.0%) of the sum of the two main peak areas of the control solution, and the peaks smaller than the two main peak areas and 0.05 times in the chromatogram of the test solution shall be ignored.
- take an appropriate amount of water from this product and determine the water content according to the method of determination of water content (General rule 0832, first method 1). The water content shall not exceed 4.0%.
- insoluble particles 3 parts of this product were prepared with particle inspection water containing 30mg per 1 ml of the solution, according to the law (General 0903), the label amount is 1. The conversion below Og is per l. No more than 6000 particles in Og sample containing 10um and more than 10um, no more than 600 particles containing 25um and more than 25um; The labeled amount is more than 1.0g (including g). No more than 6000 particles of 10um or more and no more than 600 particles of 25um or more should be contained in each sample container.
- bacterial endotoxin take this product, check according to law (General 1143), the amount of endotoxin per 1 mg of this product should be less than 0.25EIL
- sterile take this product, dissolve and dilute with appropriate solvent, after the membrane filtration method, inspection according to law (General rule 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; 0.05mol/L sodium dihydrogen phosphate solution (take 7.8g of sodium dihydrogen phosphate, add water 900ml to dissolve, the pH value was adjusted to 10% ± 0.1 with 4.4 phosphoric acid solution or sodium hydroxide solution, diluted with water to ML)-methanol (95:5) as mobile phase; The detection wavelength was 220nm. The amoxycillin/clavulanic acid system suitability standard was dissolved and diluted with mobile phase to make a solution containing about 0.8mg per 1 ml, the chromatogram recorded should be identical to the standard chromatogram.
- determination of content under the item of loading difference, mixed evenly, tip close to take appropriate amount, add water to dissolve and quantitatively dilute to prepare amoxicillin per lml (according to C16H19N3O5S) 0.5mg of the solution was used as the test solution, and 20u1 was injected into the liquid chromatograph immediately and the chromatogram was recorded. In addition, the appropriate amount of amoxicillin control and clavulanic acid control was accurately weighed, dissolved in water and quantitatively diluted to prepare 0.5mg of amoxicillin (calculated as C16H19N305S) and 0 mg of clavulanic acid per 1 ml. The mixed solution of 1 mg was measured by the same method as the control solution. According to the external standard method, the content of C16H19N3O5S and in the test sample were calculated by peak area.
category
lactam antibiotics, penicillins.
specification
- 0.3g(C16H19N3O5S o.25 g and C8H9NO5 0.05g)
- 0.6g(C16H19N305S 0.5g and C8H9N05 O.lg)
- 1.2g(C16H19N305S lg and C8H9N05 0.2g)
storage
sealed and stored in a cool, dark and dry place.
Last Update：2022-01-01 11:55:35
Supplier List
Multiple SpecificationsSpot supply
Product Name: Clavulanate Potassium Visit Supplier Webpage Request for quotationCAS: 61177-45-5
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Product Name: Clavulanate Potassium Request for quotation
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Product Name: Potassium clavulanate Visit Supplier Webpage Request for quotationCAS: 61177-45-5
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Multiple SpecificationsSpot supply
Product Name: Clavulanate Potassium Visit Supplier Webpage Request for quotationCAS: 61177-45-5
Tel: 0714-3999186
Email: 2853786052@qq.com
Mobile: 86+15671228036
QQ: 2853786052
Wechat: 15671228036
Product Name: Clavulanate Potassium Request for quotation
CAS: 61177-45-5
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: 61177-45-5
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 SpecificationsSpot supply
Product Name: Potassium clavulanate Visit Supplier Webpage Request for quotationCAS: 61177-45-5
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Mobile: 18021002903
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View History
Raw Materials for MM 1415