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 |
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 |
Hazard Symbols | Xn - Harmful |
Risk Codes | 22 - Harmful if swallowed |
WGK Germany | 3 |
RTECS | VB1997500 |
HS Code | 29339900 |
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 |
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%.
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.
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.
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.
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.
take this product, dry to constant weight at 105°C, weight loss shall not exceed 0.5% (General rule 0831).
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%.
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.
measured by high performance liquid chromatography (General 0512).
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.
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.
quinolones.
light-shielded, sealed, and stored in a dry place.
This product contains lomefloxacin hydrochloride according to lomefloxacin (C17H19F2N303) calculation, should be 90.0% ~ 110.0% of the label amount.
This product is white or white-like tablets or film-coated tablets, white or white-like after removing the coating.
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.
with lomefloxacin hydrochloride.
calculated as C17H19F2N303 (1)0.lg (2)0.2g(3)0.3g (4)0.4g
light-shielded, sealed, and stored in a dry place.
This product contains lomefloxacin hydrochloride according to lomefloxacin (C17H19F2N303) calculation, should be 90.0% ~ 110.0% of the label amount.
The content of this product is white or white powder.
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.
with lomefloxacin hydrochloride.
calculated as C17H19F2N303 (1)0.lg (2)0.2g
light-shielded, sealed, and stored in a dry place.