Cephalexin (free base)
Cephalexin
CAS: 15686-71-2
Molecular Formula: C16H17N3O4S
Cephalexin (free base) - Names and Identifiers
| Name | Cephalexin |
| Synonyms | Cefalexin Cephalexin cefa-iskia D-Cephalexin Cefalexin hydrate Cephalexin (free base) (6r-(6alpha,7beta(r*)))-ino)-3-methyl-8-oxo 7-(d-alpha-aminophenylacetamido)desacetoxycephalosporanicacid 7-(d-alpha-amino-phenylacetamido)-3-methyl-3-cepheme-4-carboxylic acid 7-(d-2-amino-2-phenylacetamido)-3-methyl-delta3-cephem-4-carboxylicacid 7-(d-2-amino-2-phenylacetamido)-3-methyl-delta(sup3)-cephem-4-carboxylica 7-beta-(d-alpha-amino-alpha-phenylacetylamino)-3-methyl-3-cephem-4-carboxyli 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylicacid,7-(2-amino-2-phenylaceta 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylicacid,7-((aminophenylacetyl)am |
| CAS | 15686-71-2 |
| EINECS | 239-773-6 |
| InChI | InChI=1/C16H17N3O4S.H2O/c1-8-7-24-15-11(14(21)19(15)12(8)16(22)23)18-13(20)10(17)9-5-3-2-4-6-9;/h2-6,10-11,15H,7,17H2,1H3,(H,18,20)(H,22,23);1H2/t10-,11-,15-;/m1./s1 |
| InChIKey | AVGYWQBCYZHHPN-CYJZLJNKSA-N |
Cephalexin (free base) - Physico-chemical Properties
| Molecular Formula | C16H17N3O4S |
| Molar Mass | 347.39 |
| Density | 1.3040 (rough estimate) |
| Melting Point | 196-198°C |
| Boling Point | 727.4±60.0 °C(Predicted) |
| Specific Rotation(α) | [α]D20 +144～+158° (c=0.5, H2O) (Calculated on dehydrous basis) |
| Flash Point | 393.7°C |
| Water Solubility | 12.5g/L(25 ºC) |
| Solubility | Slightly soluble in water, insoluble in ethanol, chloroform, ether. |
| Vapor Presure | 3.27E-22mmHg at 25°C |
| Appearance | White crystalline powder |
| Merck | 13,1986 |
| pKa | 5.2, 7.3(at 25℃) |
| PH | pH (5g/l, 25℃) 3.5～5.5 |
| Storage Condition | Keep in dark place,Inert atmosphere,2-8°C |
| Refractive Index | 1.6320 (estimate) |
| MDL | MFCD00056877 |
| Physical and Chemical Properties | Monohydrate ([23325-78-2]) is a white or yellowish crystalline powder. Slightly soluble in water, insoluble in ethanol, chloroform, ether. |
| Use | The product is the first synthetic oral cephalosporin, acid, penicillinase are stable. Its antibacterial mechanism, antibacterial spectrum and indications were similar to cefalotin, but the antibacterial strength was weaker than that of cefalotin and it was used for light infection. |
Cephalexin (free base) - Risk and Safety
| Hazard Symbols | Xn - Harmful |
| 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. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) |
| WGK Germany | 3 |
| RTECS | XI0350000 |
| HS Code | 29419000 |
| Toxicity | TDLo orl-hmn: 14 mg/kg/D:GIT AACHAX -,361,68 |
Cephalexin (free base) - Reference
| Reference Show more | 1. Zhao Xiaojuan, Zhang Qimei, Zeng Jingdi, Bai Weidong, Chen Haiguang. Development and application of ampicillin sodium molecularly imprinted sensor [J]. Guangzhou Chemical Industry, 2016,44(12):1-3 40. 2. Li Shaoni, Sun Kang, Shen Yehua, et al. Study on Preparation of Shell-based Mesoporous Activated Carbon from Amygdala by Steam Activation [J]. Biomass Chemical Engineering, 2018, 52(3):9-15. 3. Gao Mingkun, Zhang Zhi, Qian Fang. Toxicology of Mixed Bacteria Preparation (BMX), functional Test and Effect on Fattening Pigs [J]. Feed Research, 2018, No.485(04):66-71. 4. Zhang Zheng, Li Panjie, Jiang Caiyun, et al. Investigation and Research on Metals and Antibiotics in Urban Sewage Treatment Process [J]. Journal of Nanjing Normal University (Engineering Technology Edition), 2018, 018(002):86-92. 5. Liu Minxuan, zhao Xingran, Yu Lu, Lu Haozhi, Wang Xianghong. Rapid Detection of Cefalexin Residues in Animal-derived Food with Colloidal Gold Test Strip [J]. Food research and development, 2020,41(15):150-155. 6. Wang, Kunjie, et al. "One-step synthesis of carbon nanodots for sensitive detection of cephalexin." RSC Advances 5.26 (2015): 20511-20515.Wang, Kunjie, et al. "One-step synthesis of carbon nanodots for sensitive detection of cephalexin." RSC Advances 5.26 7. Xiong, rongrong, et al. "Activated Carbon Developed from Amygdalus Pedunculata Shell for Cephalexin Removal: Kinetics and Equilibrium Study." IOP Conference Series: Materials Science and Engineering. Vol. 774. No. 1. IOP Publishing, 2020. 8. Ai-Yue Hao, Xue-Qing Wang, Yan-Zhen Mei, Jun-Fang Nie, Ya-Qiong Yang, Chuan-Chao Dai,A smartphone-combined ratiometric fluorescence probe for specifically and visibly detecting cephalexin, spectrochimica Acta Part A: Molecular and Biomolecular Spectroscop 9. [IF = 3.361] Kunjie Wang et al. "One-step synthesis of carbon nanodots for sensitive detection of cephalexin." Rsc Adv. 2015 Feb;5(26): 20511-20515 10. [IF = 5.548] Jing Hu et al. "A high sensitive visual sensor for tetracycline in food samples by a double-signal response fluorescent nanohybrid." Food Control. 2020 Feb;108:106832 11. [IF = 4.36] Qingsong Qu et al. "Effects of fermented ginseng on the gut microbiota and immunity of rats with antibiotic-associated diarrhea." J Ethnopharmacol. 2021 Mar;267:113594 12. [IF = 4.821] Weidao Yu et al. "A turn-on fluorescent aptasensor for ampicillin detection based on gold nanoparticles and CdTe QDs." Microchem J. 2022 Aug;179:107454 |
Cephalexin (free base) - Standard
Authoritative Data Verified Data
(6R,7R )-3-methyl -7-[(R)-2-amino-2-phenylacetylamino]-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid hydrate. Calculated as anhydrous, containing Cefalexin (based on C16H17N3O4S) shall not be less than 95.0%.
Last Update：2024-01-02 23:10:35
Cephalexin (free base) - Trait
Authoritative Data Verified Data
- This product is white to yellowish crystalline powder; Slightly odorous.
- This product is slightly soluble in water and insoluble in ethanol or ether.
specific rotation
take this product, precision weighing, water dissolution and quantitative dilution of about 5mg per lml solution, according to the law (General 0621), specific rotation of 149 ° to 158 °.
absorption coefficient
take this product, precision weighing, add water to dissolve and quantitatively dilute to make a solution containing about 20ug per lml, according to UV-visible spectrophotometry (General 0401), the absorbance was measured at a wavelength of 262nm, and the absorption coefficient was 220 to 245.
Last Update：2022-01-01 11:41:26
Cephalexin (free base) - 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 1090).
Last Update：2022-01-01 11:41:27
Cephalexin (free base) - Exam
Authoritative Data Verified Data
acidity
take 50mg of this product, Add 10ml of water to dissolve, and then measure it according to law (General rule 0631). The pH value should be 3.5~5.5.
Related substances
precision weighing the appropriate amount of this product, plus mobile phase A dissolved and quantitative dilution made per lml containing about 1.0mg of the solution, as the test solution; Precision take 1 ml, 100ml flask, diluted with mobile phase A to the scale, shake, as A control solution; take about 10mg of each of the 7-amino deacetoxycephalosporanic acid control and the-phenylglycine control, weigh them accurately, put them in the same 100ml measuring flask, and add about 20ml of phosphate buffer solution with pH 7.0, ultrasonic dissolution, and then diluted to scale with mobile phase A, shake, take 2ml precision, put in 20ml measuring flask, diluted to scale with mobile phase A, shake, as impurity control solution. According to high performance liquid chromatography (General 0512) determination, using eighteen alkyl silane bonded silica gel as filler; Mobile phase A is 0.2mol/L sodium dihydrogen phosphate solution (with sodium hydroxide solution to adjust the pH value to 5.0 ), the mobile phase B is methanol, and the linear gradient elution is carried out according to the following table. The detection wavelength is 220nm, and 20ul of impurity reference solution is injected into human liquid chromatograph, and the chromatogram is recorded, the degree of separation between the peak of 7-aminodeacetoxycephalosporanic acid and the peak of a-phenylglycine should meet the requirements; Take an appropriate amount of the test solution, heat it in a water bath at 80°C for 60 minutes, and cool it, 20u1 injection liquid chromatograph, record chromatogram, separation degree between Cefalexin peak and adjacent impurity peak should meet the requirements. Accurately take 20ul of the test solution, control solution and impurity reference solution, and inject the human liquid chromatograph separately. If there are impurity peaks in the chromatogram of the test solution, 7-amino deacetoxy cephalosporanic acid and a-phenylglycine shall not exceed 1.0% based on peak area calculated by external standard method; the Peak area of other single impurities shall not be greater than 1.5 times (1.5%) of the main peak area of the control solution, and the sum of the peak areas of other impurities shall not be greater than 2.5 times (2.5%) 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.
2-naphthol
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with eighteen alkyl silane was used as a filler; Methanol-water (55:45) was used as a mobile phase at a flow rate of 1ml per minute and a detection wavelength of 225Nm. Measure the reference solution 20u1 and inject it into human liquid chromatograph, adjust the proportion of methanol in the mobile phase so that the retention time of 2-naphthol peak is about 7 minutes, the degree of separation between the 2-naphthol peak and the adjacent peak should not be less than 1.5.
assay
take an appropriate amount of this product, accurately weigh it, add mobile phase to dissolve and quantitatively dilute to make a solution containing about 10 mg per 1 ml, fully shake and take an appropriate amount of suspension, centrifuge at 15000 rpm for 5 minutes, take the supernatant as the test solution; Take the appropriate amount of 2-naphthol reference substance, the mobile phase is added to dissolve and quantitatively dilute to make a solution containing about 0.5ug per 1 ml, which is used as a reference solution. The above two solutions are accurately weighed and 20 u1 of each solution is injected respectively into the human liquid chromatograph to record the chromatogram. According to the external standard method to calculate the peak area, containing 2-naphthol content shall not exceed 0.05%.
moisture
take this product, according to the moisture determination method (General 0832 first method 1), the moisture content should be 4.0% ~ 8.0%.
ignition residue
not more than 0.2% (General rule 0841).
Last Update：2022-01-01 11:41:28
Cephalexin (free base) - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with eighteen alkyl silane was used as filler, and water-methanol-3.86% sodium acetate solution -4% acetic acid solution (742:240:15:3) was used as mobile phase; the detection wavelength is 254nm; Take appropriate amount of sample solution, heat in 80°C water bath for 60 minutes, cool, take 20ul injection human liquid chromatograph, record chromatogram, the separation degree between Cefalexin peak and adjacent impurity peak should meet the requirements.
assay
take about 50mg of this product, precision weighing, put it in 50ml measuring flask, add mobile phase to dissolve and dilute to the scale, shake, take 10ml, put it in 50ml measuring flask, dilute to the scale with mobile phase, shake, as a test solution, take the precise amount of LOL injection liquid chromatography, record the chromatogram; Take the appropriate amount of cefalexin, the same method for determination. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 11:41:29
Cephalexin (free base) - Category
Authoritative Data Verified Data
B-lactam antibiotics, cephalosporins.
Last Update：2022-01-01 11:41:29
Cephalexin (free base) - Storage
Authoritative Data Verified Data
light shielding, sealed, stored in the cool dark.
Last Update：2022-01-01 11:41:29
Cephalexin (free base) - Cefalexin for suspension
Authoritative Data Verified Data
This product contains Cefalexin (according to C16H17N3O4S) should be 90.0% to 110.0% of the label amount.
trait
This product is powder; Fragrance.
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
- acidity: take this product, add water to make a suspension containing 25mg of cefalexin (as measured by C16H17N3O4S) per lml, and determine it according to law (General rule 0631). The pH value should be 4.0~6.0.
- sedimentation volume ratio of this product, according to the proportion when taking, add water with force shaking for 1 minutes, static for 45 minutes, should comply with the provisions (General 0123). (For multi-dose packaging)
- the moisture content of this product shall not exceed 0832 as determined by the method for determination of moisture (General rule 2.0%, first method 1).
- others should comply with the relevant provisions under oral suspension (General rule 0123).
Content determination
take the contents under the check item of load difference, mix evenly, and weigh the appropriate amount accurately (about equivalent to cephalexin, according to C16H17N3O4S). lg ) , put it in a 100ml measuring flask, add an appropriate amount of mobile phase, fully shake to dissolve Cefalexin, then dilute the mobile phase to the scale, shake well, filter, and take 10ml of continuous filtrate with precision, in a 50ml measuring flask, dilute to the scale with the mobile phase, shake well, as a test solution, according to the method under the item of cefalexin, obtained.
category
Same As cefalexin.
specification
Based on C16H17N3O4S (1)0.5g (2)1.5G
storage
light shielding, sealed, stored in the cool dark.
Last Update：2022-01-01 11:41:30
Cephalexin (free base) - Cefalexin tablets
Authoritative Data Verified Data
This product contains Cefalexin (according to C16H17N304S) should be 90.0% to 110.0% of the label amount.
trait
This product is white tablet or sugar-coated tablet or film-coated tablet, White to milky yellow after removing the coating.
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
- relevant substances an appropriate amount of fine powder under the content determination item is taken, dissolved and diluted by adding mobile phase A to prepare about Cefalexin (in terms of C16H17N304S) per 1 ml. 1.0 mg of the solution was filtered, and the filtrate was taken as a test solution and measured according to the method under the item cephalexin. The 7-amino deacetoxy cephalosporanic acid and a-phenylglycine shall not exceed 1.0% of the labeled amount calculated by the peak area according to the external standard method; the Peak area of other individual impurities shall not be more than 2 times (2.0%) of the main peak area of the control solution, and the sum of the peak areas of other impurities shall not be more than 3 times (3.0%) of the main peak area of the control solution.
- the dissolution of this product, according to the dissolution and release determination method (General 093l first method), water 900ml as the dissolution medium, the speed of 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 the dissolution medium to make a solution containing about 25ug of cefalexin (based on C16H17N304S) per 1 ml, measure absorbance at the wavelength of 262mn according to UV-Vis spectrophotometry (General rule 0401); Take an appropriate amount of cefalexin reference by precise weighing, the dissolution medium was added to dissolve and quantitatively dilute to prepare a solution containing about 25ug per 1 ml, and the dissolution amount of each tablet was calculated by the same method. 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
Take 10 tablets of this product, precision weighing, fine grinding, precision weighing appropriate amount (about equivalent to cephalexin, according to C16H17N304S). lg ), put it in a 100ml measuring flask, add an appropriate amount of mobile phase, fully shake to dissolve Cefalexin, then dilute the mobile phase to the scale, shake well, filter, and take 10ml of continuous filtrate with precision, in a 50ml measuring flask, dilute to the scale with the mobile phase, shake well, as a test solution, according to the method under the item of cefalexin, obtained.
category
Same As cefalexin.
specification
Based on C16H17N304S (1)0.125g (2) 0.25g(3)0.5g
storage
light shielding, sealed, stored in the cool dark.
Last Update：2022-01-01 11:41:31
Cephalexin (free base) - Cefalexin Capsules
Authoritative Data Verified Data
This product contains Cefalexin (according to C16H17N304S) should be 90.0% to 110.0% of the label amount.
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
- appropriate amount of contents under the item of difference in loading amount of related substances, add mobile phase A to dissolve and dilute to prepare A solution containing about 1.0 mg of cephalexin (as measured by C16H17N304S) per 1 ml, filter, the filtrate was taken as the test solution, and the determination was carried out according to the method of Cefalexin. The 7-amino deacetoxy cephalosporanic acid and a-phenylglycine shall not exceed 1.0% of the labeled amount calculated by the peak area according to the external standard method; the Peak area of other individual impurities shall not be more than 2 times (2.0%) of the main peak area of the control solution, and the sum of the peak areas of other impurities shall not be more than 3 times (3.0%) of the main peak area of the control solution.
- moisture the contents of this product shall not contain more than 0832 of moisture as determined by the method for moisture determination (General rule 9.0%, 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 the dissolution medium to make a solution containing about 25ug of cefalexin (based on C16H17N304S) per 1 ml, measure absorbance at the wavelength of 262mn according to UV-Vis spectrophotometry (General rule 0401); Take an appropriate amount of cefalexin reference by precise weighing, the dissolution medium is added to dissolve and quantitatively dilute to prepare a solution containing about 25ug per 1 ml, which is determined by the same method, and the dissolution amount of each particle is calculated. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
- others should comply with the relevant provisions under the capsule (General 0103).
Content determination
take the contents under the difference of loading amount, mix evenly, weigh an appropriate amount (approximately equivalent to 0.lg of cefalexin, based on C16H17N304S), put it in a 100ml measuring flask, and add an appropriate amount of mobile phase, fully shake to dissolve Cefalexin, then dilute to the scale with mobile phase, shake well, filter, take 10ml filtrate accurately, put it in 50ml measuring flask, dilute to the scale with mobile phase, shake well, as a test solution, it was obtained by measuring according to the method under cephalexin.
category
Same As cefalexin.
specification
by C16H17N304S (1)0.125g (2)0.25g
storage
light shielding, sealed, stored in the cool dark.
Last Update：2022-01-01 11:41:31
Cephalexin (free base) - CefalexinGranules
Authoritative Data Verified Data
This product contains Cefalexin (according to C16H17N3O4S) should be 90.0% to 110.0% of the label amount.
trait
This product is soluble granules.
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
- acidity: take this product, add water to make a suspension containing 25mg of cefalexin (as measured by C16H17N3O4S) per lml, and determine it according to law (General rule 0631). The pH value should be 4.0~6.0.
- the moisture content of this product shall not exceed 0832 as determined by the method for determination of moisture (General rule 2.0%, first method 1).
- 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, weigh an appropriate amount (approximately equivalent to 0.lg of cefalexin, as measured by C16H17N304S), put it in the measuring flask, and add an appropriate amount of mobile phase, fully shake to dissolve cephalexin, then dilute to the scale with mobile phase, shake well, filter, take 10ml filtrate accurately, put it in 50ml children's bottle, dilute to the scale with mobile phase, shake well, as a test solution, it was obtained by measuring according to the method under cephalexin.
category
Same As cefalexin.
specification
Based on Cl6H17N304S (l)50mg (2)125mg
storage
light shielding, sealed, stored in the cool dark.
Last Update：2022-01-01 11:41:32
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Product Name: Cefalexin Visit Supplier Webpage Request for quotationCAS: 15686-71-2
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Multiple SpecificationsSpot supply
Product Name: Cephalexin monohydrate Visit Supplier Webpage Request for quotationCAS: 15686-71-2
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Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
Spot supply
Product Name: Cefalexin Visit Supplier Webpage Request for quotationCAS: 15686-71-2
Tel: 0714-3999186
Email: 2853786052@qq.com
Mobile: 86+15671228036
QQ: 2853786052
Wechat: 15671228036
Multiple SpecificationsSpot supply
Product Name: Cephalexin monohydrate Visit Supplier Webpage Request for quotationCAS: 15686-71-2
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
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