177325-13-2
Levofloxacin Hydrochloride
CAS: 177325-13-2
Molecular Formula: C18H21ClFN3O4
177325-13-2 - Names and Identifiers
177325-13-2 - Physico-chemical Properties
| Molecular Formula | C18H21ClFN3O4 |
| Molar Mass | 397.83 |
| Boling Point | 571.5°C at 760 mmHg |
| Flash Point | 299.4°C |
| Solubility | Aqueous Base (Slightly), DMSO (Slightly, Heated), Methanol (Slightly) |
| Vapor Presure | 6.7E-14mmHg at 25°C |
| Appearance | Solid |
| Color | White to Pale Beige |
| Storage Condition | under inert gas (nitrogen or Argon) at 2-8°C |
| MDL | MFCD03265511 |
177325-13-2 - Risk and Safety
| HS Code | 29349990 |
177325-13-2 - Standard
Authoritative Data Verified Data
The content of levofloxacin (based on C18H20FN3O4) should be 98.5% to 102.0% based on the water-free and solvent-free materials.
Last Update：2024-01-02 23:10:35
177325-13-2 - Trait
Authoritative Data Verified Data
- This product is white to light yellow crystalline powder, odorless.
- This product is slightly soluble in water, slightly soluble in ethanol, insoluble in ether; Soluble in glacial acetic acid, slightly soluble in 0.lmol/L hydrochloric acid solution.
specific rotation
take this product, precision weighing, add methanol to dissolve and quantitatively dilute to make a solution containing about 10 mg per lml, and determine according to law (General 0621), the specific rotation should be from one to 92 ° to one to 99 °.
Last Update：2022-01-01 11:35:45
177325-13-2 - Differential diagnosis
Authoritative Data Verified Data
- take an appropriate amount of this product and the ofloxacin reference substance, respectively, add the mobile phase under the right ofloxacin item to dissolve and dilute to prepare 0. A solution of 1 mg and 0.02mg was used as the test solution and the control solution. According to the method under the right ofloxacin test, the retention time of the main peak of the test solution should be consistent with the retention time of the Levofloxacin peak (after) in the main peak of the control solution.
- take an appropriate amount of this product, add 0.1 mol/L hydrochloric acid solution was dissolved and diluted to prepare a solution containing about 5ug per 1 ml, which was determined by UV-Vis spectrophotometry (General 0401), there is a maximum absorption at the wavelengths of 226nm and 294nm, and a minimum absorption at the wavelength of 263nm.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 1128).
Last Update：2022-01-01 11:35:46
177325-13-2 - Exam
Authoritative Data Verified Data
pH
take this product, add water to make a solution containing lOmg per lml, and determine it according to law (General 0631). The pH value should be 6.8~8.0.
clarity of the solution
take 5 parts of this product and add water to make 5mg solution per lml, the solution should be clear; If it is turbid, compare it with No. 2 Turbidity standard solution (General rule 0902 first method), none should be more concentrated.
absorbance
take 5 parts of this product, add water to dissolve and quantitatively dilute to make a solution containing 5mg per lml, according to UV-visible spectrophotometry (General 0401), determination of absorbance at the wavelength of 450mn, are not more than 0.1.
Related substances
take this product, precision weighing, add 0.1 mol/L hydrochloric acid solution was dissolved and quantitatively diluted to make about 1.0 mg of the solution, as the test solution, take the appropriate amount of precision, with 0.1 mol/L hydrochloric acid solution was quantitatively diluted to prepare a solution containing 2ug per 1 ml as a control solution. An appropriate amount of the control solution was accurately taken and quantitatively diluted with 0.1 mol/L hydrochloric acid solution to prepare a solution containing about 0.2ug per 1 ml as a sensitivity solution. In addition, weigh about 15mg of the reference product of impurity A accurately, put it in A 100ml measuring flask, add 6mol/L ammonia solution (lml) and an appropriate amount of water to dissolve, dilute it with water to the scale, shake well, and take 2ml accurately, in A 100ml measuring flask, dilute to the scale with water, and shake well to serve as A reference solution for impurity A. According to the determination by high performance liquid chromatography (General rule 0512), silica gel bonded with eighteen alkyl silane was used as the filler; Ammonium acetate sodium perchlorate solution (7.0g ammonium acetate and sodium perchlorate, ml water was added to dissolve, adjust pH to 2 with phosphoric acid)-acetonitrile (85:15) as mobile phase A and acetonitrile as mobile phase B; Perform linear gradient elution as shown in the following table. The column temperature was 40°C; The flow rate was 1 ml per minute. Weigh appropriate amounts of levofloxacin control, ciprofloxacin control and impurity E control, plus 0.1 mol/L hydrochloric acid solution is dissolved and diluted to prepare about levofloxacin l per 1 ml. 5ug mixed solution of 0 mg, ciprofloxacin and impurity E, 10u1 injection liquid chromatograph, with 294nm as the detection wavelength, record chromatogram, levofloxacin peak retention time is about 15 minutes. The resolution between levofloxacin peak and impurity E peak and between levofloxacin peak and ciprofloxacin peak should be greater than 2.0 and 2.5, respectively. The sensitivity solution 10u1 was injected into the liquid chromatograph, and the detection wavelength was 294nm. The signal to noise ratio of the peak height of the main component should be greater than 10. Then the sample solution, the control solution and the impurity A reference solution of 10 u1 were accurately measured, and the human liquid chromatograph was injected respectively. The detection wavelength was 294mn and 238nm, and the chromatogram was recorded. If there are impurity peaks in the chromatogram of the test solution, impurity A(238nm detection) shall be calculated by the peak surface according to the external standard method, and shall not exceed 0.3%. Other single impurities (294mn detection) the peak area shall not be greater than the main peak area of the control solution (0.2% ) , and the sum of the peak areas of other impurities (detected at 294nm) shall not be greater than 2.5 times (0.5%) of the main peak area of the control solution. The peaks in the chromatogram of the test solution which are smaller than the main peak area of the sensitivity solution are ignored.
dexofloxacin
take an appropriate amount of this product, add the mobile phase to dissolve and dilute to make about l in each lml. O mg solution, as a test solution, take an appropriate amount of precision, quantitatively dilute with mobile phase to prepare a solution containing about 10ug per 1 ml, and determine by liquid chromatography (General 0512). With eighteen alkyl silane bonded silica gel as filler; Copper sulfate D-phenylalanine solution (take 1> phenylalanine 1.32g and copper sulfate lg, add water 1000ml to dissolve, adjust the pH value to 3.5 with sodium hydroxide solution)-Methanol (82:18) as mobile phase; Column temperature 40°C, detection wavelength of 294nm. Take appropriate amounts of levofloxacin and ofloxacin, add mobile phase to dissolve and quantitatively dilute to make a solution containing levofloxacin 1 mg and ofloxacin 20ug per lml, inject into liquid chromatograph, record chromatogram, ofloxacin and levofloxacin were discharged sequentially, and the resolution of right and left isomer peaks should meet the requirements. Take the sensitivity of solution 20u1 injection liquid chromatography, the signal to noise ratio of the peak height of the main component should be greater than 10. Then, 20 u1 of the test solution and the control solution are respectively injected into the human liquid chromatograph, record chromatogram 6 the area of the peak of ofloxacin in the chromatogram of the test solution shall not be greater than the area of the main peak of the control solution (1.0%).
residual solvent
take the right amount of this product, precision weighing, with internal standard solution (weigh the right amount of acetone, diluted with 0.5mol/L hydrochloric acid solution to make every 1 ml containing 0.Olmg solution) dissolve and quantitatively dilute to make a solution containing lOOmg per lml, Take 5ml with precision, place it in a top empty bottle, seal it, and use it as a test solution; Take methanol and ethyl alcohol separately, precision weighing, quantitative dilution with internal standard solution to prepare solutions containing 300ug and 500ug of methanol and ethanol respectively per lml. Take 5ml for precision measurement, place in a top empty bottle, and seal, as a control solution; Determined according to the residual solvent assay (General 0861 first method). The capillary column with polyethylene glycol (PEG-20M)(or similar polarity) as stationary liquid was used as the chromatographic column; The column temperature was 40°C; The inlet temperature was 150°C; The detector temperature was 180°C; the equilibrium temperature of the headspace bottle was 85 ° C.; The equilibrium time was 30 minutes; The reference solution was injected into the headspace, and the chromatogram was recorded. The separation degree between acetone peak, methanol peak and ethanol peak shall meet the requirements. The test solution and the reference solution were injected by Headspace, and the chromatograms were recorded. According to the internal standard method, the residual amount of methanol and ethanol should be calculated by the ratio of peak area.
moisture
take this product, according to the moisture determination method (General 0832 first method), the moisture content should be 2.0% ~ 3.0%.
ignition residue
Take lg of this product, put it in a platinum crucible, and check it according to law (General rule 0841). The remaining residue 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 law 0821, Law II).
Last Update：2022-01-01 11:35:47
177325-13-2 - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with octylsilane as filler; Ammonium acetate sodium aerogel solution (taking ammonium acetate 4.0g and 7.0g of sodium perchlorate were dissolved by adding 1300ml of water and adjusting the pH value to 2.2 with phosphoric acid. Acetonitrile (85:15) was used as the mobile phase; The detection wavelength was 294mn. Weigh appropriate amounts of levofloxacin control, ciprofloxacin control and impurity E control, plus 0.1 mol/L hydrochloric acid solution was dissolved and diluted to make a mixed solution containing about 0.1 mg of levofloxacin, 5 tons of ciprofloxacin and impurity E per 1 ml. 10u1 was injected into the liquid chromatograph and the chromatogram was recorded, the retention time of the Levofloxacin peak is about 15 minutes, and the resolution between the Levofloxacin peak and the impurity E peak and the Levofloxacin peak and the ciprofloxacin peak should be greater than 2.0 and 2.5, respectively.
assay
take about 50mg of this product, weigh it accurately, put it in a 50ml measuring flask, add 0.1 mol/L hydrochloric acid solution dissolved and quantitatively diluted to the scale, shake, precision take 5ml, put 50ml flask, with 0.lmol/L hydrochloric acid solution was diluted to scale, and then shaken well. As the test solution, Lol was accurately measured and injected into human liquid chromatograph, and the chromatogram was recorded, add 0.lmol/L hydrochloric acid solution was dissolved and quantitatively diluted to make each lml containing 0.1 mg of the solution, the same method to determine, according to the external standard method to calculate the amount of peak area in the sample. That's right.
Last Update：2022-01-01 11:35:48
177325-13-2 - Category
Authoritative Data Verified Data
quinolones.
Last Update：2022-01-01 11:35:48
177325-13-2 - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 11:35:48
177325-13-2 - Cravit (Levofloxacin Tablets)
Authoritative Data Verified Data
This product contains levofloxacin (based on C18H20FN3O4) should be 90.0% to 110.0% of the label amount.
trait
This product is a film-coated tablet, after removing the coating, white to light yellow.
identification
- take an appropriate amount of fine powder of this product and add 0.1 mol / L hydrochloric acid solution was dissolved and diluted to make a solution containing about 1 mg of levofloxacin (based on C18H20FN304) per 1ml, filtered, and the appropriate amount of filtrate was taken, dilute with mobile phase to make about levofloxacin (based on C18H20FN304) per 1ml. Olmg solution, as a test solution; Another ofloxacin control, plus 0.1 mol / L hydrochloric acid solution was dissolved and diluted to make about 0.1 mg of the solution, an appropriate amount was taken in a precise amount, and diluted with the mobile phase to prepare a solution containing about 0.02mg per 1ml as a reference solution. The retention time of the main peak of the test solution should be consistent with the retention time of the Levofloxacin peak (after) in the main peak of the control solution.
- take an appropriate amount of fine powder of this product and add 0.1 mol /L hydrochloric acid solution was dissolved and diluted to make about 10 tons of levofloxacin (based on C18H20FN304) per 1 ml, filtered, and the filtrate was taken, as determined by UV-Vis spectrophotometry (General rule 0401), there is a maximum absorption at wavelengths of NM and nm and a minimum absorption at wavelengths of Nm.
examination
- Related substances take an appropriate amount of fine powder of this product, weigh it accurately, add 0.1 mol / L hydrochloric acid solution dissolved and quantitatively diluted to make about levofloxacin per 1 mL (based on C18H20FN304) 1.0 mg of solution, filter, take the filtrate as the test solution; According to the method under the item of levofloxacin, impurity A (238 nm detection) according to the external standard method to calculate the peak area, not over 0.3% of the labeled amount, other single impurities (294mn detection) Peak area shall not be greater than 1.5 times (0.3%) of the main peak area of the control solution, other impurities (294mn detection) the sum of peak areas shall not be greater than 3.5 times (0.7%) the area of the main peak of the control solution.
- dissolution dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), hydrochloric acid solution (9- 1000 )900ml as the dissolution medium, the rotation speed is 100 rpm, and the operation is carried out according to law. After 45 minutes, 10ml of the solution is taken, filtered, and the appropriate amount of the filtrate is taken, the solution containing about 5.5ug of levofloxacin (based on C18H20FN304) per 1 ml was prepared by quantitative dilution with dissolution medium, and the absorbance was measured at the wavelength of 294nm by ultraviolet-visible spectrophotometry (General rule 0401); in addition, an appropriate amount of levofloxacin reference substance was accurately weighed, dissolved and quantitatively diluted with dissolution medium to make a solution containing about 5.5ug per 1 ml, which was determined by the same method to calculate the dissolution amount of each tablet. 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 levofloxacin, 0.lg according to C18H20FN304), put it in a 100ml measuring flask, add 0 • lmol/L hydrochloric acid solution to dissolve and dilute to the scale, shake well, filter, Take 5ml of continuous filtrate accurately, put it in 50ml measuring flask, use 0.1 mol/L hydrochloric acid solution was diluted to the scale, and then shaken to obtain a test solution, which was measured according to the method of levofloxacin.
category
Same as levofloxacin.
specification
Based on C18H20FN304 (1) O.lg (2)0.5g
storage
light shielding, sealed storage.
Last Update：2022-01-01 11:35:49
177325-13-2 - Levofloxacin eye drops
Authoritative Data Verified Data
This product contains levofloxacin (based on C18H20FN304) should be 90.0% to 110.0% of the label.
trait
This product is a light yellow to light yellow or light yellow green clear liquid.
identification
- take an appropriate amount of this product and use 0.1 mol/L hydrochloric acid solution diluted to make about levofloxacin per 1 mL (based on C18H20FN304) 0.lmg solution, precise amount of appropriate amount, quantitative dilution with mobile phase made per lml containing about levofloxacin (by) 0.Olmg solution, as a test solution; Take an appropriate amount of ofloxacin control, plus 0.1 mol/L hydrochloric acid solution was dissolved and diluted to make about 0. An appropriate amount of 1 mg solution was quantitatively diluted with mobile phase to prepare a solution containing about 0.02mg per 1 ml as a reference solution. The test was performed according to the method in the item levofloxacin dexofloxacin. The retention time of the main peak of the test solution should be consistent with the retention time of the Levofloxacin peak (after) in the main peak of the control solution.
- take an appropriate amount of this product and use 0. Dilute 1 mol / L hydrochloric acid solution to make a solution containing about 5ug of levofloxacin (based on C18H20FN304) per 1 ml, and determine it by UV-Vis spectrophotometry (General 0401), there is maximum absorption at wavelengths of 226nm and 294nm.
examination
- the pH value should be 6.0 to 7.0 (General 0631).
- precision measurement of related substances take appropriate amount of this product, use 0.1 mol/L hydrochloric acid solution is quantitatively diluted to make a solution containing about 1.0mg of levofloxacin (calculated) per 1 ml, which is used as a test solution and determined according to the method under levofloxacin, impurity A(238mn detection) shall be calculated by the peak area according to the external standard method, and shall not exceed 0.3% of the labeled amount. The Peak area of other individual impurities (294nm detection) shall not be greater than 1.5 times (0.3%) of the main peak area of the control solution, the sum of the peak areas of other impurities (detected at 294nm) shall not be greater than 3.5 times (0.7%) the area of the main peak of the control solution.
- benzalkonium bromide if benzalkonium bromide is used as a preservative, it is determined by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Acetonitrile-triethylamine phosphoric acid solution (4ml of triethylamine and 7ml of phosphoric acid, diluted to 1000ml with water)(65:35) as mobile phase; The detection wavelength was 214nm.
- The determination method is to take an appropriate amount of this product and quantitatively dilute it with water to make a solution containing about 5ug of benzalkonium bromide per lml. Take 20u1 and inject it into human liquid chromatograph to record the chromatogram, same method determination. The sample containing benzalkonium bromide shall be 80.0% ~ 120.0% of the labeled amount calculated by peak area according to external standard method.
- osmolality the osmolality ratio should be 0.9 to 1.1 (General 0632).
- others shall comply with the relevant provisions under Ophthalmic Preparations (General rule 0105).
Content determination
take an appropriate amount of this product and use 0. Quantitative dilution of 1 mol/ L hydrochloric acid solution is made to contain about levofloxacin per 1 mL (based on C18H20FN304). A 1 mg solution was obtained as a test solution by measurement according to the method described in the case of levofloxacin.
category
quinolones.
specification
5ml:24.4mg (based on C18H20FN304)
storage
seal, shading, room temperature storage.
Last Update：2022-01-01 11:35:50
177325-13-2 - Levofloxacin Hydrochloride capsules
Authoritative Data Verified Data
This product contains Levofloxacin Hydrochloride and levofloxacin (based on C18H20FN304) should be 90.0% ~ 110.0% of the label children.
identification
- take an appropriate amount of the content of this product (about 10mg equivalent to levofloxacin, based on C18H20FN304), put it in a dry stopper, add about 10mg malonic acid and 0.5 of acetic anhydride, after heating in a water bath for 5-10 minutes, the solution was red-brown in color.
- take an appropriate amount of the contents of this product and add 0.1 mol/L hydrochloric acid solution dissolved and diluted to make about levofloxacin per 1 mL (based on C13H20FN304). 1mg of the solution was filtered, the appropriate amount of the filtrate was taken, and the solution containing 0.01mg of levofloxacin (calculated as C18H20FN304) per 1 ml was prepared by dilution with mobile phase as the test solution, plus O. 1 mol/L hydrochloric acid solution was dissolved and diluted to make about O. 1mg of the solution was diluted with mobile phase to prepare a solution containing 0.02mg per 1 ml as a reference solution. The test was carried out according to the method described in the item Levofloxacin Hydrochloride dexofloxacin. The retention time of the main peak of the test solution should be consistent with the retention time of the Levofloxacin peak (after) in the main peak of the control solution.
- take an appropriate amount of the contents of this product, add water to shake to dissolve Levofloxacin Hydrochloride, filter, and the filtrate shows chloride to identify the reaction of (1) (General 0301).
examination
- Related substances take an appropriate amount of the contents of this product, precision weighing, add 0.1 mol/L hydrochloric acid solution was dissolved and quantitatively diluted to prepare a solution containing about 1.0 mg of levofloxacin (according to C18H20FN304) per 1 ml as the test solution, impurity A (238mn detection) shall be calculated by peak area according to external standard method, and shall not exceed 0.3% of the labeled amount. Other single impurity (294mn detection) Peak area shall not be greater than 1.5 times (0.3%) of the main peak area of the control solution, and other impurities (294nm detection) the sum of peak areas shall not be greater than 3.5 times (0.7%) the area of the main peak of the control solution.
- dissolution dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), hydrochloric acid solution (9-1000)900ml as the dissolution medium, the rotation speed is 50 rpm, operate according to law, after 30 minutes, take 10ml of the solution, filter, take the appropriate amount of filtrate, dilute with hydrochloric acid solution (9-1000) to make about levofloxacin (based on C18H20FN304) per lml. 5.5ug of the solution, according to UV-visible spectrophotometry (General rule 0401), determination of absorbance at the wavelength of 294nm, another precision weighing levofloxacin reference standard appropriate amount, add hydrochloric acid solution (9-1000) dissolve and quantitatively dilute to make a solution containing about 5.5ug per 1 ml, and measure with the same method, and calculate the amount of dissolution of each particle. 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 (about 0.lg equivalent to levofloxacin, based on C18H20FN304), put it in a 100ml measuring flask, and add O. 1 mol/L hydrochloric acid solution dissolved and diluted to the scale, shake, filter, precision take the remaining filtrate 5ml, 50ml flask, with 0.1 mol/L hydrochloric acid solution was diluted to the scale, and then shaken, and as a test solution, it was obtained by measuring according to the method under the item of Levofloxacin Hydrochloride.
category
Same as Levofloxacin Hydrochloride.
specification
Based on C18H20FN3O4 (1 )0.lg (2)0.2g(3)0.25g
storage
light shielding, sealed storage.
Last Update：2022-01-01 14:21:13
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Spot supply
Product Name: Levofloxacin Hydrochloride Visit Supplier Webpage Request for quotationCAS: 177325-13-2
Tel: 0714-3999186
Email: 2853786052@qq.com
Mobile: 86+15671228036
QQ: 2853786052
Wechat: 15671228036
Product Name: Levofloxacin Hydrochloride Request for quotation
CAS: 177325-13-2
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: 177325-13-2
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: Levofloxacin Hydrochloride Visit Supplier Webpage Request for quotationCAS: 177325-13-2
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
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