Levofloxacin Methylate
3-carboxy-1-ethyl-6-fluoro-1,4-dihydro-7-(4-methyl-1-piperazinyl)-4-oxoquinoline monomethanesulphonate
CAS: 70458-95-6
Molecular Formula: C18H24FN3O6S
Levofloxacin Methylate - Names and Identifiers
| Name | 3-carboxy-1-ethyl-6-fluoro-1,4-dihydro-7-(4-methyl-1-piperazinyl)-4-oxoquinoline monomethanesulphonate |
| Synonyms | AKOS 91194 Pefloxacin Mesylate Pefloxacin mesylate Pefloxacine Mesylate Levofloxacin Methylate Pefloxacin Methane Sulphonate PEFLOXACIN MESYLATE, HIGH PURITY 1-ETHYL-6-FLUORO-7-(4-METHYL-PIPERAZIN-1-YL)-4-OXO-1,4-DIHYDRO-QUINOLINE-3-CARBOXYLIC ACID 1-Ethyl-6-fluoro-7-(4-methylpiperazin-1-yl)-4-oxoquinoline-3-carboxylic acid monomethanesulfonate 3-carboxy-1-ethyl-6-fluoro-1,4-dihydro-7-(4-methyl-1-piperazinyl)-4-oxoquinoline monomethanesulphonate 3-quinolinecarboxylic acid,1,4-dihydro-1-ethyl-6-fluoro-7-(4-methyl-1-piperazinyl)-4-oxo-,monomethanesulfonate, dihydrate |
| CAS | 70458-95-6 |
| EINECS | 274-613-9 |
| InChI | InChI=1/C17H20FN3O3.CH4O3S/c1-3-20-10-12(17(23)24)16(22)11-8-13(18)15(9-14(11)20)21-6-4-19(2)5-7-21;1-5(2,3)4/h8-10H,3-7H2,1-2H3,(H,23,24);1H3,(H,2,3,4) |
Levofloxacin Methylate - Physico-chemical Properties
| Molecular Formula | C18H24FN3O6S |
| Molar Mass | 429.46 |
| Melting Point | >255°C (dec.) |
| Boling Point | 529.1°C at 760 mmHg |
| Flash Point | 273.8°C |
| Solubility | DMSO 14 mg/mL Water 67 mg/mL Ethanol <1 mg/mL |
| Vapor Presure | 5.05E-12mmHg at 25°C |
| Appearance | Solid |
| Color | Off-White to Pale Beige |
| Storage Condition | Refrigerator |
| MDL | MFCD09028102 |
Levofloxacin Methylate - Risk and Safety
| Risk Codes | R11 - Highly Flammable R34 - Causes burns |
| Safety Description | S16 - Keep away from sources of ignition. S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S36/37/39 - Wear suitable protective clothing, gloves and eye/face protection. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) |
Levofloxacin Methylate - Standard
Authoritative Data Verified Data
This product is 1-ethyl-6-fluoro-7-[4-methylpiperazine + YL] -4-oxo-1, 4-dihydroquinoline-3-carboxylic acid methanesulfonic acid dihydrate. Pefloxacin (07H20FN303) shall not be less than 76.4% calculated as anhydrous.
Last Update：2024-01-02 23:10:35
Levofloxacin Methylate - Trait
Authoritative Data Verified Data
- This product is white to yellowish crystalline powder.
- This product is soluble in water, slightly soluble in ethanol, and slightly soluble in dichloromethane.
Last Update：2022-01-01 11:38:51
Levofloxacin Methylate - Differential diagnosis
Authoritative Data Verified Data
- take about 30mg of this product, add 0.2g of sodium hydroxide, add a few drops of water, dissolve it and then put it on a small fire on an alcohol lamp to evaporate to carbonization, add a few drops of water and 2mol/L hydrochloric acid solution 3 ~ 4ml, slowly heat, that is, sulfur dioxide gas is generated, which can make the wet potassium iodate starch test paper (take the filter paper strip and soak it in the equal volume mixture of 5% potassium iodate solution and starch indicator solution, then take it out and dry it.) the color was blue.
- take an appropriate amount of this product and the pefloxacin reference substance, respectively add anhydrous ethanol to make a solution containing about 5mg of pefloxacin per 1 ml, stand still, and take the supernatant as the test solution and the reference solution; take pefloxacin control and ofloxacin control, add 0.1 mol/ L hydrochloric acid was dissolved, and anhydrous ethanol was added to prepare a solution containing about 0.5mg of pefloxacin and 0.5mg of ofloxacin per 1 ml as a system-applicable solution. According to the thin layer chromatography (General 0502) test, absorb the above three solutions each 2 u1, respectively, on the same silica gel GF254 thin layer plate, with ethyl acetate-methanol-concentrated ammonia solution (5:6:2.5) for the development of the solvent, expand, take out, dry, under the UV lamp (365nm) view, the system for the applicability of the solution should show two clear color blue-purple spots (the main spot) and light blue and green spots ^ 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.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 933).
- two items (2) and (3) above can be selected as one item.
Last Update：2022-01-01 11:38:52
Levofloxacin Methylate - Exam
Authoritative Data Verified Data
acidity
take this product, add water to make a solution containing about 10 mg per lml, and determine it according to law (General 0631). The pH value should be 3.5~4.5.
clarity and color of solution
take 5 parts of this product, each 0.58g, respectively, and add 0902 of water to dissolve the solution. The solution should be clear and colorless, shall not be more concentrated; If the color is developed, it shall not be deeper in comparison with the yellow-green No. 5 standard colorimetric solution (General Principles 0901 first method). (For injection)
Related substances
take an appropriate amount of this product, add the mobile phase to dissolve and dilute to prepare a solution containing about 0.2mg of pefloxacin per 1ml as a test solution; Take 1ml for precision measurement and put it in a 100ml measuring flask, dilute to the scale with the mobile phase, shake, and serve as a control solution. According to the chromatographic conditions under the content determination item, 20 u1 of each of the test solution and the control solution are accurately measured and injected into the human liquid chromatograph respectively, and the chromatogram is recorded to 3 times of the retention time of the main component peak. 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%).
moisture
take this product, add methanol-dichloromethane (1:5) mixed solution to dissolve, according to the moisture determination method (General 0832 first method 1) determination, moisture content should be 7.0% ~ 8.5%.
ignition residue
take l.Og of this product, put it in a platinum crucible, and check it according to law (General rule 0841). The residue left shall not exceed 0.1%.
Heavy Gold
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).
bacterial endotoxin
take this product, check according to law (General 1143), the amount of endotoxin per 1 mg pefloxacin should be less than 0.75EU. (For injection)
Last Update：2022-01-01 11:38:52
Levofloxacin Methylate - 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; 0.04mol/L potassium dihydrogen phosphate solution -0.05mol/L tetrabutylammonium aoxylate solution-acetonitrile (80:8:9) mobile phase (pH adjusted to 4.0 with phosphoric acid); Column temperature was 40°C; Detection wavelength was 273nm. Take the appropriate amount of pefloxacin and norfloxacin, add mobile phase to dissolve and dilute to make a mixed solution containing 20 μg of pefloxacin and norfloxacin in each lml, and inject 20u1 into human liquid chromatograph, the peak order is norfloxacin, pefloxacin, pefloxacin peak retention time is about 15 minutes, the separation between norfloxacin peak and pefloxacin peak should be greater than 6.0, the separation degree between pefloxacin peak and adjacent impurity peak should meet the requirements.
assay
take an appropriate amount of this product, accurately weigh it, add water to dissolve and quantitatively dilute it to prepare a solution containing about 20ug of pefloxacin per 1 ml as a test solution, accurately measure 20u1 injection liquid chromatograph, record the chromatogram; Take the pefloxacin reference substance, determine with the same method, calculate the content of C17H20FN3O3 in the test sample by peak area according to the external standard method.
Last Update：2022-01-01 11:38:53
Levofloxacin Methylate - Category
Authoritative Data Verified Data
quinolones.
Last Update：2022-01-01 11:38:53
Levofloxacin Methylate - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 11:38:53
Levofloxacin Methylate - Pefloxacin Mesylate Tablets
Authoritative Data Verified Data
This product contains pefloxacin mesylate according to pefloxacin (C17H20FN303), should be 93.0% ~ 107.0% of the label amount.
trait
This product is sugar-coated tablet or film-coated tablet, which shows off-white or yellowish after removing the coating.
identification
- take an appropriate amount of fine powder of this product (about 50mg equivalent to pefloxacin), add 10ml of water to dissolve, filter, take an appropriate amount of filtrate, evaporate on a water bath, and take about 30mg of residue, the same reaction was shown according to the Identification Test (1) under the item pefloxacin mesylate.
- take an appropriate amount of fine powder of this product and add anhydrous ethanol to make a solution containing about 5mg of pefloxacin per 1 ml, stand still, and take the supernatant as the test solution, the same results were shown in the identification (2) test under pefloxacin mesylate.
- 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.
- two items (2) and (3) above can be selected as one item.
examination
- after removing the coating, weigh 10 tablets accurately and finely, weigh an appropriate amount, dissolve and dilute with mobile phase to make a solution containing about 0.2mg of pefloxacin per 1 ml, filtration, take the filtrate, as a test solution; According to pefloxacin mesylate under the determination method, should comply with the provisions.
- dissolution of this product, according to the dissolution and release determination method (General 0931 second method), with 0.lmol/L hydrochloric acid solution 1000ml as the dissolution medium, the speed is 50 rpm, according to the operation, after 45 minutes, take 10ml solution, filtration, precision take the appropriate amount of filtrate, the solution containing about 4mg pefloxacin per 1 ml was prepared by quantitative dilution with dissolution medium, and the absorbance was measured at 277nm wavelength according to ultraviolet-visible spectrophotometry (General rule 0401), precision weighing, dissolution and quantitative dilution of dissolution medium solution containing about 4ug per lml, the same method to determine, calculate the dissolution of each tablet. The limit is 75% 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, remove the coating, precision weighing, fine, precision weighing an appropriate amount (about 0.lg equivalent to pefloxacin), put it in a 200ml measuring flask, add water to shake and dilute to the scale, shake, filter, take the appropriate amount of filtrate accurately, quantitatively dilute with mobile phase to make a solution containing about 2ug of pefloxacin per lml, as a test solution. According to pefloxacin mesylate under the determination of the method, that is obtained.
category
with pefloxacin mesylate.
specification
calculated as C17H20FN303 (1)0.lg (2)0.2g
storage
light shielding, sealed storage.
Last Update：2022-01-01 11:38:54
Levofloxacin Methylate - Pefloxacin mesylate injection
Authoritative Data Verified Data
This product is a sterilized aqueous solution of pefloxacin mesylate, containing pefloxacin (C17H20FN303) should be 90.0% ~ 110.0% of the label amount.
trait
This product is colorless to yellowish or yellowish green clear liquid.
identification
- 1ml of this product was taken and evaporated to dryness on a water bath, and about 30mg of the residue was taken to show the same reaction according to the Identification Test (1) under the item of pefloxacin mesylate.
- take this product, add anhydrous ethanol to make a solution containing 5mg pefloxacin per 1 ml, stand still, take the supernatant, as a test solution, according to the identification of pefloxacin mesylate (2) the same results were seen in one trial.
- 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.
- two items (2) and (3) above can be selected as one item.
examination
- the pH value should be 3.0 to 5.0 (General 0631).
- the color of this product, quantitative dilution of water made in each lml containing pefloxacin 40mg solution, and yellow or yellow-green 5 standard colorimetric liquid (General Principles 0901 The first method) comparison, not deeper.
- appropriate amount of related substances of this product is diluted with mobile phase to prepare a solution containing about 0.2mg of pefloxacin per 1 ml, which is used as a test solution; The determination shall be in accordance with the method for pefloxacin mesylate.
- the bacterial endotoxin of this product is taken and checked according to law (General rule 1143). The amount of endotoxin in pefloxacin per 1 mg should be less than 0.75EU.
- sterile take this product, diluted with appropriate solvent, treated by membrane filtration method, inspection according to law (General rule 1101), should comply with the provisions.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
an appropriate amount of this product is accurately measured, and a solution containing about 20ug of pefloxacin per 1 ml is prepared by quantitative dilution with mobile phase, which is used as a test solution and measured according to the method of pefloxacin mesylate.
category
with pefloxacin mesylate.
specification
by C17H20FN303 (l)2ml:0.2g (2)5ml:0.4g
storage
light shielding, closed storage.
Last Update：2022-01-01 11:38:55
Levofloxacin Methylate - Pefloxacin mesylate capsules
Authoritative Data Verified Data
This product contains pefloxacin mesylate according to pefloxacin (C17H20FN3O3) calculation, should be 93.0% ~ 107.0% of the label amount.
trait
The content of this product is white to yellowish powder.
identification
- take an appropriate amount of the contents of this product (about 50mg equivalent to pefloxacin), add 10ml of water to dissolve, filter, take an appropriate amount of filtrate, and evaporate on a water bath, about 30mg of the residue was taken and the same reaction was revealed by the test of identification (1) under the item of pefloxacin mesylate.
- take an appropriate amount of the contents of this product, add anhydrous ethanol to make a solution containing about 5mg of pefloxacin per 1 ml, stand still, and take the supernatant as the test solution, the same results were shown in the identification (2) test under pefloxacin mesylate.
- 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.
- two items <2) and (3) above can be selected as one item.
examination
- the contents under the item of difference in loading amount of related substances shall be mixed evenly, weighed and taken, dissolved and diluted with mobile phase to make a solution containing about 0.2mg of pefloxacin per 1 ml, and filtered, take the continued filtrate as the test solution; According to the method of pefloxacin mesylate, it should be in accordance with the provisions.
- dissolution of this product, according to the dissolution and release determination method (General 0931 second method), with 0.lmol/L hydrochloric acid solution 1000ml as the dissolution medium, the speed is 50 rpm, according to the operation, after 45 minutes, take 10ml solution, filtration, precision take the appropriate amount of filtrate, the solution containing about 4ug pefloxacin per 1 ml was prepared by quantitative dilution with dissolution medium, and the absorbance was measured at the wavelength of 277nm according to UV-visible spectrophotometry (General rule 0401), precision weighing, dissolution and quantitative dilution of dissolution medium to prepare about 1 mL solution, the same method to determine, calculate the 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 of pefloxacin) accurately, put it in a 200ml measuring flask, shake with water, dissolve it and dilute it to the scale, shake, filter, take appropriate amount of filtrate with precision, quantitatively dilute with mobile phase to make a solution containing about 20ug pefloxacin per 1 ml, and use it as a test solution for determination according to the method for pefloxacin mesylate, that's right.
category
with pefloxacin mesylate.
specification
calculated as C17H20FN303 (1)0.lg (2)0.2g
storage
light-shielded, sealed, and stored in a dry place.
Last Update：2022-01-01 11:38:56
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CAS: 70458-95-6
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Product Name: 3-carboxy-1-ethyl-6-fluoro-1,4-dihydro-7-(4-methyl-1-piperazinyl)-4-oxoquinoline monomethanesulphonate Request for quotation
CAS: 70458-95-6
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: 70458-95-6
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: Pefloxacin Mesylate Visit Supplier Webpage Request for quotationCAS: 70458-95-6
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
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