76824-35-6
famotidine
CAS: 76824-35-6
Molecular Formula: C8H15N7O2S3
76824-35-6 - Names and Identifiers
| Name | famotidine |
| Synonyms | FAMOTIDINE Famotidine famotidine Famotidine (Patented-No Supply) FAMOTIDINE, IMPURITY C BP STANDARD 3-(((2-((diaminomethylene)amino)-4-thiazolyl)methyl)thio)-n(sup2)-sulfamoylp 3-(((2-((aminoiminomethyl)amino)-4-thiazolyl)methyl)thio)-n-(aminosulfonyl)p [amino-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]-methyl]thio]propylidene] [amino-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]-methyl]thio]propylidene]s 3-[[[2-[(Aminoiminomethyl)amino]-4-thiazolyl]methyl]thio]-N-(aminosulfonyl)propanimidamide |
| CAS | 76824-35-6 |
| EINECS | 616-396-9 |
| InChI | InChI=1/C8H15N7O2S3/c9-6(15-20(12,16)17)1-2-18-3-5-4-19-8(13-5)14-7(10)11/h4H,1-3H2,(H2,9,15)(H2,12,16,17)(H4,10,11,13,14) |
| InChIKey | XUFQPHANEAPEMJ-UHFFFAOYSA-N |
76824-35-6 - Physico-chemical Properties
| Molecular Formula | C8H15N7O2S3 |
| Molar Mass | 337.45 |
| Density | 1.5111 (rough estimate) |
| Melting Point | 163-164°C |
| Boling Point | 562.7±60.0 °C(Predicted) |
| Water Solubility | 1.1 mg/mL |
| Solubility | DMSO 67 mg/mL (198.54 mM);Water <1 mg/mL (<1 mM);Ethanol <1 mg/mL (<1 mM) |
| Appearance | neat |
| Color | White to Off-White |
| pKa | pKa 6.76(H2O t=23.0) (Uncertain) |
| Storage Condition | 2-8°C |
| Sensitive | Sensitive to light |
| Refractive Index | 1.7400 (estimate) |
| MDL | MFCD00079297 |
| Physical and Chemical Properties | Melting point 163-164°C water-soluble 1.1 mg/mL |
| Use | H2 inhibitor |
76824-35-6 - Risk and Safety
| Hazard Symbols | T - Toxic |
| Risk Codes | R20/21/22 - Harmful by inhalation, in contact with skin and if swallowed. R45 - May cause cancer R61 - May cause harm to the unborn child |
| Safety Description | S22 - Do not breathe dust. S24/25 - Avoid contact with skin and eyes. S53 - Avoid exposure - obtain special instructions before use. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) S36/37/39 - Wear suitable protective clothing, gloves and eye/face protection. |
| WGK Germany | 2 |
| RTECS | UA2300000 |
| HS Code | 29341000 |
| Toxicity | LD50 i.v. in mice: 244.4 mg/kg (Yasufumi) |
76824-35-6 - Nature
Open Data Verified Data
white to yellowish white crystals, odorless, slightly bitter. The melting point was 163-164 °c. Solubility (%) at 20 °c: dimethylformamide 80, acetic acid 50, methanol 0.3, water 0.1, ethanol, ethyl acetate and chloroform <0. 01. Very difficult to dissolve in acetonitrile or acetone, almost insoluble
In chloroform or ether.
Last Update：2024-01-02 23:10:35
76824-35-6 - Preparation Method
Open Data Verified Data
N-methyl thiourea and 1,3-dichloroacetone cyclization to produce 2-guanidin-4-chloromethylthiazole, and then reaction with thiourea, then reaction with chloropropionitrile, 2 guanidino -4-[(cyanoethylthio) methyl] thiazole is formed, alcoholysis is carried out with methanol, and famotidine is obtained by amination.
Last Update：2022-01-01 09:22:51
76824-35-6 - Standard
Authoritative Data Verified Data
This product is [1-chloro-3-[[2-[ (diaminomethylene) amino]-4-oxazolyl] methyl] Thio] propylidene] thiamide. Calculated as dried product, containing no less than 98.0% of C8H15N702S3.
Last Update：2024-01-02 23:10:35
76824-35-6 - Trait
Authoritative Data Verified Data
- This product is a white or off-white crystalline powder; It becomes darker in light.
- This product is slightly soluble in methanol, very slightly soluble in acetone, almost insoluble in water or chloroform; Soluble in glacial acetic acid.
melting point
The melting point of this product (General rule 0612 The first method) is 160~165 deg C, the melting decomposition at the same time.
Last Update：2022-01-01 13:37:54
76824-35-6 - Use
Open Data Verified Data
It was successfully trial-produced by Japan Yamanaka Pharmaceutical Co., Ltd. in 1979 and was first launched in Japan in January 1935. It is a histamine H2 receptor blocker, which has obvious inhibitory effect on gastric acid secretion, and can also inhibit the secretion of pepsin. It has strong selectivity and can permanently inhibit gastric acid secretion. Strong effect, long maintenance time, wide range of safety, no anti androgen and interference with drug metabolism enzymes and other effects. Its antagonistic effect is more than 30 times that of cimetidine and 14 times that of ranitidine. The doses used were only 1120 of cimetidine and 1/7 of ranitidine. For peptic ulcer disease, gastric and duodenal ulcer, reflux esophagitis, upper gastrointestinal bleeding.
Last Update：2022-01-01 09:22:52
76824-35-6 - Differential diagnosis
Authoritative Data Verified Data
- take this product, add pH 4.5 potassium dihydrogen phosphate buffer (take potassium dihydrogen phosphate 13.6g, add water to dissolve and dilute to 1000ml, adjust the pH value to 4.5 ), make a solution containing 15ug per 1 ml, according to ultraviolet-visible spectrophotometry (General rule 0401), there is a maximum absorption at the wavelength of 266mn, and the absorbance is 0.45 to 0.48.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 781).
Last Update：2022-01-01 13:37:54
76824-35-6 - Safety
Open Data Verified Data
mice were injected intravenously with LDso:244. 4 mg/kg.
Last Update：2022-01-01 09:22:52
76824-35-6 - Exam
Authoritative Data Verified Data
clarity and color of acidic solution
take this product 0.5g, add hydrochloric acid solution (4.5-100)10ml to dissolve, the solution should be clear and colorless; If the color, with the yellow No. 2 Standard Colorimetric solution (General Principles 0901 The first method) comparison, not deeper.
Related substances
take this product, add an appropriate amount of methanol to dissolve, with phosphate buffer (take sodium dihydrogen phosphate 13.6g, put 900ml of water, adjust the pH value to 7.0±0.1 with lmol/L sodium hydroxide solution, add water to 1000ml, mix homogeneously and mix 930ml with 70ml of acetonitrile, then dilute to prepare a solution containing 0.5mg of famotidine per 1 ml as the test solution, A solution containing 5ug per 1 ml was prepared as a control solution by quantitative dilution with the above phosphate buffer. According to the high performance liquid chromatography (General rule 0512), with the eighteen alkyl silane bonded Gui glue as the filler (hip masil C18,4.6mm X mm, 5um or equivalent performance column); with acetate buffer (take sodium acetate 13.6g, put in 900ml water, adjust the pH value to 6.0±1.0 with glacial acetic acid, add water to 1000ml)-acetonitrile (93:7) as mobile phase A, acetonitrile as mobile Phase B, the detection wavelength was 270mn, the flow rate was 1.5ml per minute; The column temperature was 35°C. Gradient elution was performed as follows. Take about 25mg of famotidine, add 2ml of acetonitrile and 2ml of the above phosphate buffer solution to dissolve, add 3ml of 0.5mol/L hydrochloric acid solution, heat at 40°C in water bath for 5 minutes, and add 3ml of 0.5mol/L sodium hydroxide solution, 5ml of 1 mol/L sodium hydroxide solution was added, and 5ml of 1 mol/L hydrochloric acid solution was heated in a water bath at 60 ° C. For 5 minutes, and diluted with the above phosphate buffer solution to prepare a solution containing about 0.5mg per 1 ml as a system-suitable solution. Measure the 20u1 of the solution and inject it into human liquid chromatograph, record the chromatogram, adjust the proportion of mobile phase, and make the retention time of the chromatographic peak of famotidine about 10 minutes, the retention times of the impurity I peak and the impurity II peak relative to the famotidine peak were approximately 0.7 and 1.2. The number of theoretical plates shall not be less than 5000 based on the calculation of famotidine peak, and the separation degree between famotidine peak and adjacent impurity peaks shall meet the requirements. 20ul of control solution and 20ul of test solution were accurately measured and injected into human liquid chromatograph respectively, and the chromatogram was 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 0.3 times (0.3%) the area of the main peak of the control solution, and the sum of the areas of each impurity peak shall not be greater than the area of the main peak of the control solution (1.0%).
loss on drying
take this product, dry to constant weight at 105°C, weight loss shall not exceed 0.5% (General rule 0831).
ignition residue
take l.Og of this product and check it according to law (General rule 0841). The residue left shall not exceed 0.1%.
Heavy metals
The residue left under the item of taking the ignition residue shall not contain more than 10 parts per million of heavy metal when examined by law (General Principles 0821, Law II).
Last Update：2022-01-01 13:37:55
76824-35-6 - Content determination
Authoritative Data Verified Data
take this product about 0.12g, precision weighing, add glacial acetic acid 20ml and acetic anhydride 5ml dissolved, add crystal violet indicator solution 1 drop, with perchloric acid titration solution (0.1 mol/L) titration until the solution is green, and the titration result is corrected by a blank test. Each 1 ml of perchloric acid titration solution (0.1 mol/L) corresponds to 16.87mg of C8H15N702S3.
Last Update：2022-01-01 13:37:56
76824-35-6 - Category
Authoritative Data Verified Data
H2 receptor antagonist.
Last Update：2022-01-01 13:37:56
76824-35-6 - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 13:37:56
76824-35-6 - Famotidine tablets
Authoritative Data Verified Data
This product contains famotidine (C8H15N702S3) should be 90.0% to 110.0% of the label amount.
trait
This product is a white tablet, sugar-coated tablet or film-coated tablet, after removing the coating, white or white.
identification
- 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 solution under the content uniformity item was taken and measured by ultraviolet-visible spectrophotometry (General 0401), and there was a maximum absorption at a wavelength of 266mn.
examination
- The filtrate under the content determination item is taken as the test solution; The appropriate amount is taken for precision measurement, A 5% solution per 1 ml was prepared as a control solution by quantitative dilution with phosphate buffer under the content measurement. The determination was carried out according to the method for related substances of famotidine. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than the area of the main peak of the control solution (1.0% ) , and the sum of each impurity peak area shall not be greater than 2 times the area of the main peak of the control solution (2.0%).
- Content uniformity take 1 tablet of this product, put it in a 100ml measuring flask, add pH 4.5 phosphate buffer solution (take potassium dihydrogen phosphate 13.6g, add appropriate amount of water to dissolve and dilute to 1000ml, shake well, adjust the pH value to 4.5) 40ml, shake to dissolve, dilute to the scale with pH 4.5 phosphate buffer, shake, filter, and take appropriate amount of filtrate accurately, the solution containing famotidine (10ug) per 1 ml was prepared by quantitative dilution with pH 4.5 phosphate buffer as the test solution, according to UV-Vis spectrophotometry (General 0941), the absorbance was measured at the wavelength of 266nm; The appropriate amount of famotidine was accurately weighed, dissolved and quantitatively diluted with pH 4.5 phosphate buffer solution to prepare a solution containing 10ug per lml, and the same method was used to determine and calculate the content, should comply with the provisions (General 0941),
- dissolution dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), with pH 4.5 phosphate buffer solution for dissolution medium, the speed is 100 rpm, operate according to the law, after 30 minutes, take the solution to filter, take the appropriate amount of the filtrate, dilute with the dissolution medium to make the solution containing 10ug per lml, according to the method under the content uniformity item, the elution amount of each tablet was calculated from the "measurement of absorbance at a wavelength of 266mn by ultraviolet-visible spectrophotometry (general document 0401)", which was measured according to the law. The limit is 80% of the labeled amount 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
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as the filler (krolmasil C18, 4.6mm X 250mm, 5um or performance equivalent column); the mobile phase A under the item of related substances of famotidine was used as mobile phase; The detection wavelength was 270nm, the flow rate was 1.5ml per minute; The column temperature was 35°C. The system applicable solution 20u1 under related substances of famotidine was injected into the liquid chromatograph, and the chromatogram was recorded. The mobile phase ratio was adjusted so that the retention time of the chromatographic peak of famotidine was about 10 minutes, and the retention times of the impurity I peak and the impurity II peak relative to the famotidine peak were about 0.7 and 1.2. The number of theoretical plates shall not be less than 5000 based on the calculation of famotidine peak, and the separation degree between famotidine peak and adjacent impurity peaks shall meet the requirements.
- determination of 20 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (about equivalent to famotidine 25mg), put in a 50ml measuring flask, add an appropriate amount of methanol, ultrasonic in cold water bath to dissolve famotidine, let it cool, use phosphate buffer solution (sodium dihydrogen phosphate 13.6g, 7.0 ml of water, adjust pH value to 0.1 ± with 1 mol/L sodium hydroxide solution, add water to 1000ml, shake, take 930ml mixed with 70ml of acetonitrile, then dilute to the scale, shake well, filter, Take 5ml of continued filtrate, put it in 50ml measuring flask, dilute to the scale with the above phosphate buffer solution, shake, as a test solution, take a precision amount of 20u1 injection of human liquid chromatography, record the chromatogram. In addition, an appropriate amount of famotidine reference substance was accurately weighed and dissolved with an appropriate amount of methanol, and diluted with the above phosphate buffer solution to prepare a reference substance solution containing about 0.05ug per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.
category
The same method was used to treat the disease.
specification
(l )10mg (2 )20mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 13:37:58
76824-35-6 - Famotidine injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of famotidine, containing famotidine (C8H15N702S3) should be 90.0% to 110.0% of the label.
trait
This product is colorless to yellowish clear liquid.
identification
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 control solution.
examination
- the pH value should be 5.0 to 6.0 (General 0631).
- the color of this product shall be inspected according to law (General rule 0901, Law 1), and shall not be deeper than the yellow No. 3 Standard Colorimetric solution.
- relevant substances take appropriate amount of this product, use phosphate buffer solution (take sodium dihydrogen phosphate 13.6g, put in 900ml of water, adjust pH value to 7.0±0.1 with 1 mol/L sodium hydroxide solution, add water to 1000ml, mix homogeneously and mix 930ml with 70ml of acetonitrile, then dilute to prepare a solution containing 0.5mg of famotidine per 1 ml as the test solution, A solution containing 5ug per 1 ml was prepared as a control solution by quantitative dilution with the above phosphate buffer. The determination was carried out according to the method for related substances of famotidine. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than 2.5 times (2.5%) of the area of the main peak of the control solution, 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.
- bacterial endotoxin take this product, according to the law inspection (General 1143), each 1 mg famotidine containing endotoxin amount should be less than 7.5EU.
- sterile take this product, treated by membrane filtration method, with 0.1% peptone solution rinse 1 times, with Staphylococcus aureus as positive control bacteria, according to law inspection (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 the filler (krolmasil C18,4.6mm X 250mm,5um or performance equivalent column); the mobile phase A under the item of related substances of famotidine was used as mobile phase; The detection wavelength was 270nm, the flow rate was 1.5ml per minute; The column temperature was 35°C. The system applicable solution under the item of related substances of famotidine 20fJ was injected into the liquid chromatograph, and the chromatogram was recorded. The mobile phase ratio was adjusted so that the retention time of the chromatographic peak of famotidine was about 10 minutes, and the retention times of the impurity I peak and the impurity n peak relative to the famotidine peak were about 0.7 and 1.2. The number of theoretical plates shall not be less than 5000 based on the calculation of famotidine peak, and the separation degree between famotidine peak and adjacent impurity peaks shall meet the requirements.
- measuring method: take 5ml of this product, put it in a 100ml measuring flask, dilute it to the scale with phosphate buffer under the item of related substances, shake it, take 5ml of this product into a 50ml measuring flask, dilute to the scale with the above phosphate buffer solution, shake well, as a test solution, take 20u1 injection of human liquid chromatography with precise volume, record the chromatogram; Take an appropriate amount of famotidine reference, precise weighing, after an appropriate amount of methanol was added and dissolved, a control solution containing about 0.05mg per 1 ml was prepared by dilution with the above phosphate buffer solution, and the measurement was carried out in the same manner. According to the external standard method to calculate the peak area, that is.
category
Same as famotidine.
specification
2ml:20mg
storage
cold place, shading, closed storage.
Last Update：2022-01-01 13:37:59
76824-35-6 - Famotidine capsules
Authoritative Data Verified Data
This product contains famotidine (C8H15N702S3) should be 90.0% ~ 110.0% of the label.
trait
The content of this product is white or white powder.
identification
- 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 solution under the item of dissolution was taken and measured by ultraviolet-visible spectrophotometry (General 0401), which showed a maximum absorption at a wavelength of 266nm.
examination
- The filtrate under the content determination item is taken as the test solution; The appropriate amount is taken for precision measurement, A solution containing 5ug per 1 ml was prepared as a control solution by quantitative dilution with phosphate buffer under the content determination item. The determination was carried out according to the method for related substances of famotidine. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than the area of the main peak of the control solution (1.0% ) , and the sum of each impurity peak area shall not be greater than 2 times the area of the main peak of the control solution (2.0%).
- Content uniformity take 1 capsule of this product, pour the content into a 100ml measuring flask, use a small amount of pH 4.5 phosphate buffer (take 13.6g of potassium dihydrogen phosphate, add appropriate amount of water to dissolve and dilute to 1000ml, shake well, adjust the pH value to 4.5) wash the capsule, wash the capsule, add 40ml of pH 4.5 phosphate buffer to the measuring flask, shake to dissolve, dilute to the scale with pH 4.5 phosphate buffer, shake well, filter, take appropriate amount of filtrate accurately, dilute quantitatively with pH 4.5 phosphate buffer to prepare 10ug solution containing famotidine per lml, according to UV-visible spectrophotometry (General rule 0401), determine the absorbance at the wavelength of 266nm; Take an appropriate amount of famotidine reference substance, add pH 4.5 phosphate buffer solution and quantitative dilution to prepare a solution containing 10ug per lml, the same method to determine, calculate the content, should comply with the provisions (General 0941).
- dissolution the dissolution of this product was determined according to the dissolution and release determination method (General rule 0931 method 1), and the dissolution medium was 4.5 phosphate buffer solution, and the rotation speed was 50 rpm, operate in accordance with the law, after 30 minutes, take the solution to filter, take the appropriate amount of the filtrate with precision, and dilute with the dissolution medium to prepare the solution containing 10ug per lml as the test solution, according to the method under the content uniformity item, from the "ultraviolet-visible spectrophotometry (General rule 0401), absorbance determination at the wavelength of 266mn", according to the law, the amount of dissolution of each pellet was calculated. A limit of 800% of the labeled amount shall be met.
- others should comply with the relevant provisions under the capsule (General 0103).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silanes bonded to silicon R as a filler (krolmasil C18,4.6mm x 250mm, 5um or equivalent column); the mobile phase A under the item of related substances of famotidine was used as mobile phase; The detection wavelength was 270nm, the flow rate was 1.5ml per minute; The column temperature was 35°C. 20ul of the system applicable solution under the related substances of famotidine was injected into the human liquid chromatograph, and the chromatogram was recorded. The mobile phase ratio was adjusted so that the retention time of the chromatographic peak of famotidine was about 10 minutes, and the retention times of the impurity I peak and the impurity II peak relative to the famotidine peak were about 0.7 and 1.2. The number of theoretical plates shall not be less than 5000 based on the calculation of famotidine peak, and the separation degree between famotidine peak and adjacent impurity peaks shall meet the requirements.
- The determination method is to take 20 capsules of this product, accurately weigh and calculate the average loading. Take the contents, mix well, accurately weigh an appropriate amount (about 25mg equivalent to famotidine), put it in a 50ml measuring flask, add an appropriate amount of methanol, put the ultrasound in a cold water bath to dissolve famotidine, let it cool, use phosphate buffer solution (take 13.6g of sodium dihydrogen phosphate, put it in 7.0±0.1 ml of water, adjust the pH value to with 1 mol /L sodium hydroxide solution, add water to ML, shake well, mix 930ml with 70ml of acetonitrile, then obtain it) dilute to the scale, shake, filter, Take 5ml of the filtrate accurately, put it in a 50ml measuring flask, dilute to the scale with the above phosphate buffer, shake well, as a test solution, record chromatogram with 20ul injection liquid chromatograph; Take appropriate amount of famotidine reference substance, weigh it accurately, add appropriate amount of methanol to dissolve, the solution was diluted with the above phosphate buffer solution to form a control solution containing about 0.05mg per 1 ml, measured by the same method, and calculated by the peak area according to the external standard method.
category
Same as famotidine.
specification
20mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 13:38:00
76824-35-6 - Famotidine granules
Authoritative Data Verified Data
This product contains famotidine (C8H15N702S3) should be 90.0% to 110.0% of the label amount.
trait
This product is white or white particles; Sweet.
identification
- 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 sample solution under the content uniformity was taken and measured by ultraviolet-visible spectrophotometry (General rule 0401), and the maximum absorption was found at a wavelength of 266nm.
examination
- The filtrate under the content determination item is taken as the test solution; The appropriate amount is taken for precision measurement, A solution containing 5ug per 1 ml was prepared as a control solution by quantitative dilution with phosphate buffer under the content determination item. The determination was carried out according to the method for related substances of famotidine. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than the area of the main peak of the control solution (1.0% ) , and the sum of each impurity peak area shall not be greater than 2 times the area of the main peak of the control solution (2.0%).
- Content uniformity take 1 bag of this product, put it in a 100ml measuring flask, add pH 4.5 phosphate buffer (take potassium dihydrogen phosphate 13.6g, add appropriate amount of water to dissolve and dilute to 1000ml, shake well, adjust the pH value to 4.5)40ml, fully shake to dissolve famotidine, dilute to the scale with pH 4.5 phosphate buffer, shake, filter, take appropriate amount with precision, the solution containing famotidine (10ug) per 1 ml was prepared by quantitative dilution with pH 4.5 phosphate buffer as the test solution, according to UV-Vis spectrophotometry (General 0401), the absorbance was measured at the wavelength of 266nm; The appropriate amount of famotidine reference substance was accurately weighed, dissolved and diluted with pH 4.5 phosphate buffer solution to prepare a solution containing lOug per lml, and the same method was used for determination, calculate the content of each bag, should be consistent with the provisions (General 0941).
- dissolution dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), with pH 4.5 phosphate buffer solution for dissolution medium, the speed is 100 rpm, operate according to the law, after 20 minutes, take the solution and filter, take the filtrate 5ml, put it in a 10ml measuring flask, dilute to the scale with the dissolution medium, according to the method under the content uniformity item, from the "UV-visible spectrophotometry (General rule 0401), determination of absorbance at the wavelength of 266nm", according to the law, calculate the amount of dissolution of each bag, the limit is 85% of the label amount, the requirements shall be met.
- others should comply with the relevant provisions under The granule (General Principle 0104).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as the filler (krolmasil C18,4.6mm X 250mm,5um or performance equivalent column); the mobile phase A under the item of related substances of famotidine was used as mobile phase; The detection wavelength was 270nm, the flow rate was 1.5ml per minute; The column temperature was 35°C. The system applicable solution 20u1 under related substances of famotidine was injected into the liquid chromatograph, and the chromatogram was recorded. The mobile phase ratio was adjusted so that the retention time of the chromatographic peak of famotidine was about 10 minutes, and the retention times of the impurity I peak and the impurity II peak relative to the famotidine peak were about 0.7 and 1.2. The number of theoretical plates shall not be less than 5000 based on the calculation of famotidine peak, and the separation degree between famotidine peak and adjacent impurity peaks shall meet the requirements.
- determination of 10 bags of this product, precision weighing, calculate the average loading, take the content of the fine, precision weighing an appropriate amount (equivalent to famotidine 25mg), put it in a 50ml measuring flask, add an appropriate amount of methanol, set the ultrasound in the cold water bath to dissolve famotidine, let it cool, use phosphate buffer (take sodium dihydrogen phosphate 13.6g, put it in of water, adjust pH value to 7.0±0.1 with lmol/L sodium hydroxide solution, add water to 1000ml, mix well, mix 930ml with acetonitrile 70ml, then dilute to the scale, shake well, filter, precisely take 5ml of continuous filtrate, put it in 50ml measuring flask, dilute it to scale with the above phosphate buffer, shake it well, use it as sample solution, precisely take 20u1 and inject it into liquid chromatograph, record chromatogram; in addition, an appropriate amount of famotidine reference substance was accurately weighed and dissolved with an appropriate amount of methanol, and then diluted with the above phosphate buffer solution to prepare a reference substance solution containing about 0.05mg per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.
category
Same as famotidine.
specification
20mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 13:38:01
76824-35-6 - Famotidine for injection
Authoritative Data Verified Data
This product is a sterile freeze-dried product of famotidine. The content of famotidine (C8H15N702S3) shall be between 90.0% and 110.0% of the indicated amount calculated as the average loading.
trait
This product is white loose lumps or powder.
identification
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 control solution.
examination
- the clarity and color of the solution take this product 5, respectively, add water 2ml to dissolve, the solution should be clear and colorless.
- the acidity of this product 1, add water 20ml, shake to dissolve, according to the law (General 0631),pH value should be 4.5~6.0.
- The filtrate under the content determination item is taken as the test solution; The appropriate amount is taken for precision measurement, A solution containing about 5ug of famotidine per 1 ml was prepared by diluting with phosphate buffer under the content measurement as a control solution. The determination was carried out according to the method for related substances of famotidine. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than the area of the main peak of the control solution (1.0% ) , the sum of each impurity peak area shall not be greater than 1.5 times (1.5%) of the main peak area of the control solution.
- loss on drying: take about 0.3g of this product for precision weighing, dry under reduced pressure at 80°C to constant weight, and lose no more than 2.0% of weight (General rule 0831).
- bacterial endotoxin take this product, according to the law inspection (General 1143), each 1 mg famotidine containing endotoxin amount should be less than 5.0EU.
- sterile take this product, dissolve with 0.9% sterile sodium chloride solution, membrane filtration treatment, rinse with 0.1% peptone solution, with Staphylococcus aureus as positive control bacteria, inspection in accordance with the 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).
- the test for the suitability of the system and the conditions for testing the silica gel bonded with eighteen alkyl silanes as the filler (a chromatography column with a concentration of 4.6mm X 250mm, 5um or equivalent performance); the mobile phase A under the item of related substances of famotidine was used as mobile phase; The detection wavelength was 270nm; The flow rate was 1.5ml per minute; The column temperature was 35°C. Take the system applicable solution 20u1 under the item of related substances of famotidine and inject it into human liquid chromatograph, and record the chromatogram. The mobile phase ratio was adjusted so that the retention time of the chromatographic peak of famotidine was about 10 minutes, and the retention times of the impurity I peak and the impurity II peak relative to the famotidine peak were about 0.7 and 1.2. The number of theoretical plates shall not be less than 5000 calculated by the peak of famotidine, and the separation degree between the peak of famotidine and the adjacent impurity peaks shall meet the requirements.
- determine the contents under the item of loading difference, mix well, weigh an appropriate amount (about 25mg equivalent to famotidine), put it in a 50ml measuring flask, add an appropriate amount of methanol, shake to dissolve, adjust pH to 13.6±7.0 with 1 mol/L sodium hydroxide solution, add water to 0.1 mL, shake well, mix 930ml with 70ml of acetonitrile, (Ready) dilute to the scale, shake, filter, take the filtrate 5ml accurately, put it in 50ml measuring flask, dilute to the scale with the above phosphate buffer, shake, as a test solution, record chromatogram with 20u1 injection liquid chromatograph; Take appropriate amount of famotidine reference substance, weigh it accurately, dissolve it with appropriate amount of methanol, dilute it with the above phosphate buffer to make 0.05mg solution per 1 ml, as a control solution, the same method. According to the external standard method to calculate the peak area, that is.
category
Same as famotidine.
specification
20mg
storage
light shielding, closed storage.
Last Update：2022-01-01 13:38:02
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