1-Ethyl-6,8-difluoro-1,4-dihydro-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid hydrochloride - Names and Identifiers
Name | Lomefloxacin hydrochloride
|
Synonyms | ny198 bareon Chimono sc-47111 LOMEFLOXACIN HCL Lomefloxacin hcl LOMEFLOXACIN HYDROCHLORIDE Lomefloxacin hydrochloride 1-ETHYL-6,8-DIFLUORO-1,4-DIHYDRO-7-[3-METHYL-1-PIPERAZINYL]-4-OXO-3-QUINOLINECARBOXYLIC ACID HYDROCHLORIDE 1-Ethyl-6,8-difluoro-1,4-dihydro-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid hydrochloride 1,4-dihydro-6,8-difluoro-1-ethyl-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylicacimonohydrochloride
|
CAS | 98079-52-8
|
EINECS | 627-337-1 |
InChI | InChI=1/C17H19F2N3O3.ClH/c1-3-21-8-11(17(24)25)16(23)10-6-12(18)15(13(19)14(10)21)22-5-4-20-9(2)7-22;/h6,8-9,20H,3-5,7H2,1-2H3,(H,24,25);1H |
1-Ethyl-6,8-difluoro-1,4-dihydro-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid hydrochloride - Physico-chemical Properties
Molecular Formula | C17H20ClF2N3O3
|
Molar Mass | 387.81 |
Melting Point | 290-3000C |
Boling Point | 542.7°C at 760 mmHg |
Flash Point | 282°C |
Solubility | 1 M NaOH: soluble50mg/mL |
Vapor Presure | 1.31E-12mmHg at 25°C |
Appearance | White Solid |
Color | white to off-white |
Merck | 14,5562 |
Storage Condition | Sealed in dry,Store in freezer, under -20°C |
MDL | MFCD00214312 |
1-Ethyl-6,8-difluoro-1,4-dihydro-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid hydrochloride - Risk and Safety
Hazard Symbols | Xn - Harmful
|
Risk Codes | 22 - Harmful if swallowed
|
WGK Germany | 3 |
RTECS | VB1997500 |
HS Code | 29339900 |
1-Ethyl-6,8-difluoro-1,4-dihydro-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid hydrochloride - Reference
Reference Show more | 1. [IF=6.057] Yukun Huang et al."A sensitive aptasensor based on rolling circle amplification and G-rich ssDNA/terbium (III) luminescence enhancement for ofloxacin detection in food."Talanta. 2021 Dec;235:122783 |
1-Ethyl-6,8-difluoro-1,4-dihydro-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid hydrochloride - Standard
Authoritative Data Verified Data
This product is (±)-l-ethyl-6, 8-difluoro-1, 4-dihydro-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid hydrochloride. Calculated as dry product, containing lomefloxacin (C17H19F2N303) shall not be less than 89.2%.
Last Update:2024-01-02 23:10:35
1-Ethyl-6,8-difluoro-1,4-dihydro-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid hydrochloride - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline powder; Almost odorless.
- This product is slightly soluble in water, almost insoluble in methanol and ethanol; Soluble in sodium hydroxide solution, very slightly soluble in dilute hydrochloric acid.
Last Update:2022-01-01 15:32:48
1-Ethyl-6,8-difluoro-1,4-dihydro-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid hydrochloride - 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.
- take this product, add 0.1 mol /L hydrochloric acid solution is prepared to contain about 5ug per 1 ml of solution, according to ultraviolet-visible spectrophotometry (General 0401) determination, has the maximum absorption at the wavelength of 287nm.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 650).
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
Last Update:2022-01-01 15:32:48
1-Ethyl-6,8-difluoro-1,4-dihydro-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid hydrochloride - Exam
Authoritative Data Verified Data
acidity
take this product, add water to make a solution containing 5mg per lml, according to the law (General 0631),pH value should be 3.5~4.5.
clarity of the solution
take 5 parts of this product and add water respectively to make a solution containing about 5mg per lml, and 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), the absorbance was measured at a wavelength of 450nm, and the absorbance was not over 0.25.
Related substances
take an appropriate amount of this product, and add the mobile phase under the content determination item to dissolve and dilute to make about l in each lml. 0 mg of the solution was used as a test solution; An appropriate amount was taken in a precise amount and quantitatively diluted with the mobile phase under the content measurement item to prepare a solution containing about 10ug per 1 ml as a control solution. An appropriate amount of the control solution was accurately measured and quantitatively diluted with the mobile phase under the content measurement item to prepare a solution containing about 0.2ug per 1 ml as a sensitivity solution. According to high performance liquid chromatography (General 0512) determination. With eighteen alkyl silane bonded silica gel as filler; With sodium pentane sulfonate solution (take sodium pentane sulfonate 1.5g, ammonium dihydrogen phosphate 3.5g, add water 950ml to dissolve, adjust the pH value to 3.0 with phosphoric acid, dilute to 1000ml with water) mobile phase A, methanol as mobile phase B. The linear gradient elution was performed as follows. The detection wavelength was 287mn and the flow rate was 1.2 per minute. Take about 25mg of lomefloxacin control, add 1 ml of 30% hydrogen peroxide solution to dissolve, dilute with the mobile phase under the content determination item to make a solution containing about 1 mg per 1 ml, water bath heating for 2 hours, cooling, A solution containing two impurities with a relative retention time of about 0.8 and 1.1 was prepared, and the solution 20u1 was injected into a human liquid chromatograph, and the chromatogram was recorded. The peak retention time of lomefloxacin was about 9 minutes, the separation degree between the impurity peak at the relative retention time of about 0.8 and the lomefloxacin peak should be greater than 2.0, and the separation degree between the impurity peak at the relative retention time of about 1.1 and the lomefloxacin peak should meet the requirements. The sensitivity solution 20m1 was injected into the liquid chromatograph, and the chromatogram was recorded. The signal-to-noise ratio of the peak of the main component should be greater than 10. Then 20 u1 of the test solution and the control solution are accurately measured, and the human liquid chromatograph is injected respectively, and the chromatogram is 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 0.5 times (0.5%) 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%). The peaks in the chromatogram of the test solution which are smaller than the main peak area of the sensitivity solution are ignored.
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, put the platinum crucible, 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 burning and flooding shall not contain more than 20 parts per million of heavy metals for examination by law (General rule 0821, Law II). The residual solvent is about 0.3g, precision weighed, placed in the top empty bottle, precision plus 0.8mol/L sodium hydroxide solution 3M l to dissolve, sealed, as a test solution. Accurately weigh the appropriate amount of ether, anhydrous ethanol and acetone, and quantitatively dilute with 0.8mol/L sodium hydroxide solution to make a mixed solution containing 0.5mg each in 1 ml, and accurately take 3ml, top empty bottle, sealed, as a control solution. Determined according to the residual solvent assay (General 0861 second method). A capillary column with 100% dimethylpolysiloxane (or similar polarity) as a stationary liquid is used as a chromatographic column; The initial temperature is 50 ° C., the temperature is maintained for 5 minutes, and then the temperature is raised to 150 ° C. At a rate of 10 ° C. Per minute; the inlet temperature was 200°C; The detector temperature was 250°C; The headspace bottle equilibrium temperature was 70°C and the equilibrium time was 30 minutes. Take the reference solution into the headspace, according to the ether, acetone, ethanol elution, ether peak and acetone peak separation should meet the requirements. Take the reference solution and the test solution into the headspace respectively, record the chromatogram, and calculate the peak area according to the external standard method. The residual amount of ether, ethanol and acetone shall be in accordance with the regulations.
Last Update:2022-01-01 15:32:49
1-Ethyl-6,8-difluoro-1,4-dihydro-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid hydrochloride - 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; Sodium pentanesulfonate solution (sodium pentanesulfonate 1.5g, ammonium dihydrogen phosphate 3.0g, water 950ml to dissolve, adjust pH to with phosphoric acid, dilute to 1000ml with water)-Methanol (65:35) as mobile phase, flow rate of 1.2ml per minute, detection wavelength of 287mn. Take the system applicable solution 20u1 under the item of related substances and inject it into the human Liquid Chromatograph. The retention time of lomefloxacin is about 9 minutes, and the separation degree between the impurity peak at the relative retention time of about 0.8 and the lomefloxacin peak should be greater than 2.0, the resolution between lomefloxacin peak and impurity peak at relative retention time 1.1 should meet the requirements.
assay
take the right amount of this product, precision weighing, plus mobile phase dissolution and quantitative dilution made in each lml containing about 0. The lmg solution was used as the test solution, and 20ul was injected into the liquid chromatograph with precision, and the chromatogram was recorded. Another lomefloxacin reference substance was taken and determined by the same method. The content of lomefloxacin (C17H19F2N303) in the sample was calculated by peak area according to external standard method.
Last Update:2022-01-01 15:32:50
1-Ethyl-6,8-difluoro-1,4-dihydro-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid hydrochloride - Category
Authoritative Data Verified Data
Last Update:2022-01-01 15:32:50
1-Ethyl-6,8-difluoro-1,4-dihydro-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid hydrochloride - Storage
Authoritative Data Verified Data
light-shielded, sealed, and stored in a dry place.
Last Update:2022-01-01 15:32:50
1-Ethyl-6,8-difluoro-1,4-dihydro-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid hydrochloride - Lomefloxacin hydrochloride
Authoritative Data Verified Data
This product contains lomefloxacin hydrochloride according to lomefloxacin (C17H19F2N303) calculation, should be 90.0% ~ 110.0% of the label amount.
trait
This product is white or white-like tablets or film-coated tablets, white or white-like after removing the coating.
identification
- take an appropriate amount of fine powder of this product and add 0.lmol/L hydrochloric acid solution was dissolved and diluted to prepare a solution containing 0.5mg of lomefloxacin per 1 ml. The solution was shaken, filtered, and the filtrate was taken as the test solution. A 1 mol/L hydrochloric acid solution was dissolved and diluted to give a solution containing 0.5mg per 1 ml as a control solution. According to the thin layer chromatography (General 0502) test, absorb 5 u1 of each of the above two solutions, respectively point on the same silica gel GF 254 thin layer plate, using chloroform-methanol-ammonium chloride chloride test solution (6:4:1) as the developing solvent, expand, dry, and put the UV lamp (254mn) under inspection, the position and color of the main spot displayed by the test solution should be the same as the position and color of the main spot of the control solution.
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
- take an appropriate amount of fine powder of this product and add 0.1 mol/L hydrochloric acid solution was dissolved and diluted to prepare a solution containing about 5ug of lomefloxacin per 1 ml, and the maximum absorption was measured by UV-visible spectrophotometry (General rule 0401) at a wavelength of Nm.
- Take appropriate amount of fine powder of this product, add water, shake, filter, filtrate chloride to identify (1) reaction (General rule 0301).
- two items (1) and (2) above can be selected as one item.
examination
- Related substances take the fine powder of this product, accurately weigh the appropriate amount, add the mobile phase under the content determination item to dissolve and dilute to make about lomefloxacin l per lml. 0 mg of the solution was filtered, and the subsequent filtrate was taken as a test solution; The measurement was performed according to the method of lomefloxacin hydrochloride. 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 1.5 times (1.5%) of the main peak area of the control solution.
- dissolution dissolution of this product, according to the dissolution and release determination method (General 0931 first method), hydrochloric acid solution (9-1000) as the dissolution medium, the rotation speed is 100 rpm, operate according to the law, after 30 minutes, take the appropriate amount of solution, filter, take the appropriate amount of filtrate, dilute quantitatively with dissolution medium to make a solution containing about 5ug of lomefloxacin per lml, according to UV-Vis spectrophotometry (General rule 0401), measure absorbance at 287nm wavelength; Another precision weigh appropriate amount of lomefloxacin reference, the dissolution medium was added to dissolve and quantitatively dilute to prepare a solution containing about 5ug 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 20 tablets of this product, precision weighing, fine grinding, precision weighing to take an appropriate amount (about equivalent to lomefloxacin 0.lg), and add mobile phase to dissolve and quantitatively dilute to make it contain about lomefloxacin 0 per lml. 1 mg of the solution was shaken, filtered, and the filtrate was taken as a test solution, which was obtained by measuring according to the method of lomefloxacin hydrochloride.
category
with lomefloxacin hydrochloride.
specification
calculated as C17H19F2N303 (1)0.lg (2)0.2g(3)0.3g (4)0.4g
storage
light-shielded, sealed, and stored in a dry place.
Last Update:2022-01-01 15:32:51
1-Ethyl-6,8-difluoro-1,4-dihydro-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid hydrochloride - Lomefloxacin hydrochloride capsules
Authoritative Data Verified Data
This product contains lomefloxacin hydrochloride according to lomefloxacin (C17H19F2N303) calculation, should be 90.0% ~ 110.0% of the label amount.
trait
The content of this product is white or white powder.
identification
- take an appropriate amount of the contents of this product and add O.lmol/L hydrochloric acid solution was dissolved and diluted to prepare a solution containing 0.5mg of lomefloxacin per 1 ml. The solution was shaken, filtered, and the filtrate was taken as the test solution. A 1 mol/L hydrochloric acid solution was dissolved and diluted to give a solution containing 0.5mg per 1 ml as a control solution. According to the thin layer chromatography (General 0502) test, absorb 5 u1 of each of the above two solutions, respectively point on the same silica gel GF254 thin layer plate, with chloroform-methanol-chloride ammonium chloride test solution (6:4:1) for the development of the opening agent, expand, dry, set the UV light (254mn) under the inspection, the position and color of the main spot displayed by the test solution should be the same as the position and color of the main spot of the reference solution.
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
- take an appropriate amount of the contents of this product and add 0.1 mol/L hydrochloric acid solution was dissolved and diluted to prepare a solution containing about 5ug of lomefloxacin per 1 ml, and the maximum absorption was measured by UV-visible spectrophotometry (General rule 0401) at a wavelength of Nm.
- Take appropriate amount of fine powder of this product, add water, shake, filter, filtrate chloride to identify (1) reaction (General rule 0301).
- two items (1) and (2) above can be selected as one item.
examination
- the contents under the item of difference in loading amount of related substances shall be accurately weighed and an appropriate amount shall be taken, and dissolved and diluted with the mobile phase under the item of content determination to prepare about lomefloxacin per 1 ml. 0 mg of the solution was filtered, and the subsequent filtrate was taken as a test solution; The measurement was performed according to the method of lomefloxacin hydrochloride. 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 1.5 times (1.5%) of the main peak area of the control solution.
- dissolution dissolution of this product, according to the dissolution and release determination method (General 0931 first method), hydrochloric acid solution (9-1000) as the dissolution medium, the rotation speed is 100 rpm, operate according to the law, after 30 minutes, take the appropriate amount of solution, filter, take the appropriate amount of filtrate, dilute quantitatively with dissolution medium to make a solution containing about 5ug of lomefloxacin per lml, shake, measure absorbance at the wavelength of 287mn according to UV-Vis spectrophotometry (General rule 0401); Take appropriate amount of lomefloxacin reference by precise weighing, the dissolution medium is added to dissolve and quantitatively dilute to prepare a solution containing about 5ug per lml, which is determined by the same method, and the dissolution amount of each particle is calculated, and the limit is 80% of the labeled amount, which shall be in accordance with the regulations.
- others should comply with the relevant provisions under the capsule (General 0103).
Content determination
take the contents under the item of difference in loading amount, mix evenly, grind finely, and accurately weigh an appropriate amount (about equivalent to 0.lg of lomefloxacin), add mobile phase to dissolve and quantitatively dilute to make lomefloxacin about 0.1 mg of the solution was shaken, filtered, and the filtrate was taken. As a test solution, it was obtained by measuring according to the method of lomefloxacin hydrochloride.
category
with lomefloxacin hydrochloride.
specification
calculated as C17H19F2N303 (1)0.lg (2)0.2g
storage
light-shielded, sealed, and stored in a dry place.
Last Update:2022-01-01 15:32:53