Ofloxacin Otic
ofloxacin
CAS: 82419-36-1;100986-85-4;83380-47-6
Molecular Formula: C18H20FN3O4
Ofloxacin Otic - Names and Identifiers
Ofloxacin Otic - Physico-chemical Properties
| Molecular Formula | C18H20FN3O4 |
| Molar Mass | 361.37 |
| Density | 1.2688 (estimate) |
| Melting Point | 270-2750C |
| Boling Point | 571.5±50.0 °C(Predicted) |
| Flash Point | 299.4°C |
| Water Solubility | Soluble in acetic acid or water. Slightly soluble in methanol |
| Solubility | Slightly soluble in water or methanol. Soluble in glacial acetic acid or dichloromethane |
| Vapor Presure | 6.7E-14mmHg at 25°C |
| Appearance | off-white to light yellow crystals |
| Color | Colorless needles from ethanol |
| Maximum wavelength(λmax) | ['326nm(H2O)(lit.)'] |
| Merck | 14,6771 |
| pKa | 5.19±0.40(Predicted) |
| Storage Condition | Keep in dark place,Sealed in dry,Store in freezer, under -20°C |
| Refractive Index | 1.669 |
| MDL | MFCD00865049 |
| Physical and Chemical Properties | White or yellowish crystalline powder. |
| Use | For the treatment of respiratory tract, urinary tract, skin and soft tissue, typhoid and other bacterial infections and other infectious diseases |
Ofloxacin Otic - Risk and Safety
| Risk Codes | R22 - Harmful if swallowed R42/43 - May cause sensitization by inhalation and skin contact. R68 - Possible risk of irreversible effects R36/37/38 - Irritating to eyes, respiratory system and skin. |
| Safety Description | 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. S24/25 - Avoid contact with skin and eyes. S22 - Do not breathe dust. S37/39 - Wear suitable gloves and eye/face protection S60 - This material and its container must be disposed of as hazardous waste. |
| WGK Germany | 3 |
| RTECS | UU8815550 |
| HS Code | 29349990 |
| Toxicity | LD50 in male, female mice, male, female rats (mg/kg): 5450, 5290, 3590, 3750 orally; 208, 233, 273, 276 i.v.; >10000, >10000, 7070, 9000 s.c. (Ohno) |
Ofloxacin Otic - Upstream Downstream Industry
| Raw Materials | 2,3,4-Trifluoronitrobenzene 1-Methylpiperazine Acetone Methyl sulfoxide Potassium hydroxide Ethyl Alcohol |
Ofloxacin Otic - Reference
| Reference Show more | 1. Shi Qingxin, Yang Yang, Cai Yingying, Zhou tiili. Study on the characteristics and molecular mechanism of quinolone resistance in multi-drug resistant Mycobacterium tuberculosis [J]. Zhejiang Medical Journal, 2019,41(06):521-524 528. 2. [IF = 13.273] Yafei Hu et al."Facile preparation of sodium alginate-based gel spheres by droplet polymerization method for removal of levofloxacin from aquous solution." Chem Eng J. 2020 Jul;392:123718 3. Bolong Fang et al. [IF = 7.514]. "Glucose oxidase-induced colormetric immunization for quality detection of danofoxacin based on iron (II)." Food Chem. 2020 Oct;328:127099 4. [IF=5.455] Lu Lan et al."Quinic acid: a potential antibiofilm agent against clinical resistant Pseudomonas aeruginosa."Chin Med-Uk. 2021 Dec;16(1):1-17 5. [IF=3.368] Xiaoying Kong et al."Application of a novel thermo-sensitive injectable hydrogel in therapy in situ for drug accurate controlled release."J Biomed Mater Res B. 2020 Nov;108(8):3200-3216 6. [IF=2.363] Li Xie et al."A sensitive EZMTT method provides microscale, quantitative and high-throughput evaluation of drug efficacy in the treatment of Mycobacterium tuberculosis infectious diseases."J Microbiol Meth. 2021 Feb;181:106136 7. [IF=6.165] Shan Lu et al."Colorimetric and fluorescent dual-channel sensor array based on Eriochrome Black T/Eu3 complex for sensing of multiple tetracyclines."J Mol Liq. 2022 Apr;351:118371 8. [IF=6.331] Wei Guo et al."Cationic amphiphilic dendrons with effective antibacterial performance."J Mater Chem B. 2021 Dec;: 9. [IF=10.588] Juan Peng et al."Removal of levofloxacin by an oleaginous microalgae Chromochloris zofingiensis in the heterotrophic mode of cultivation: Removal performance and mechanism."J Hazard Mater. 2022 Mar;425:128036 |
Ofloxacin Otic - Nature
Open Data Verified Data
colorless needle-like crystals obtained from ethanol are odorless and bitter in taste. Melting point 250~257 °c (decomposition). Soluble in acetic acid, soluble in chloroform, difficult to dissolve in methanol, ethanol, acetone, chloroform or water, insoluble in ethyl acetate.
Last Update：2024-01-02 23:10:35
Ofloxacin Otic - Preparation Method
Open Data Verified Data
with 2,3, 4-trifluoro nitrobenzene as raw material, after selective alkali hydrolysis, etherification, reduction, condensation, cyclization, hydrolysis, the product was obtained by introducing V-methyl piperazine. Or phthalimide derivatives as raw materials, fluorinated to produce tetrafluorophthalimide, by hydrolysis, decarboxylation to produce 2,3,4,5 tetrafluorobenzoic acid, then chlorination, acylation, decarboxylation to produce 2,3,4,5 A four fluorine benzoyl ethyl acetate. Then, it reacts with triethyl orthoformate, 2 aminopropanol, and finally reacts with piperazine to produce ofloxacin. It is also possible to react ethyl 2,3,4,5-tetrafluorobenzoyl acetate obtained above with methylpiperazine first, introduce a piperazine group, and then introduce a side chain followed by cyclization, and then hydrolyze to ofloxacin.
Last Update：2022-01-01 09:08:58
Ofloxacin Otic - Standard
Authoritative Data Verified Data
This product is (±) -9-fluoro -2, 3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7h-pyrido [1,2, 3-de] -1, 4-benzoxazine-6-carboxylic acid. Calculated as dried product, the content of C18H20FN304 shall not be less than 97.5%.
Last Update：2024-01-02 23:10:35
Ofloxacin Otic - Trait
Authoritative Data Verified Data
- This product is white to yellowish crystalline powder; No odor; Light gradual color change.
- This product is slightly soluble in chloroform, slightly soluble or very slightly soluble in water or methanol; Soluble in glacial acetic acid or sodium hydroxide solution, dissolved in 0.lmol/L hydrochloric acid solution.
specific rotation
take this product, precision weighing, and chloroform dissolved and quantitative dilution of each lml solution containing about 10 mg, according to the law (General 0621), the specific rotation is from 1 ° to 1 °.
Last Update：2022-01-01 15:36:37
Ofloxacin Otic - Use
Open Data Verified Data
Japan's first pharmaceutical company and the joint development of qunma University, Japan Akita factory production, launched in April 1985. The third generation of quinolone synthetic antibacterial drugs, with broad antibacterial spectrum, strong antibacterial activity, good bioavailability, safe and effective, low toxicity, no drug resistance and other advantages. It has a good antibacterial effect on a variety of gram-positive and gram-negative bacteria, and also has a certain antibacterial effect on anaerobic bacteria. For sensitive bacteria caused by respiratory infections, intestinal infections, skin and soft tissue infections, urinary tract infections.
Last Update：2022-01-01 09:08:59
Ofloxacin Otic - Differential diagnosis
Authoritative Data Verified Data
- take an appropriate amount of this product and ofloxacin control, add 0.1 mol/L hydrochloric acid solution (5mg per 5mg of ofloxacin plus 0.1 mol/L hydrochloric acid solution lm l) to dissolve, diluted with ethanol to make a solution containing about 1 mg per 1 ml, as the test solution and the reference solution; Take the right amount of ofloxacin control and ciprofloxacin control, plus O. 1 mol/L hydrochloric acid solution (5mg per 5mg of ofloxacin plus 0.1 mol/L hydrochloric acid solution (1 ml) was dissolved and diluted with ethanol to prepare a solution containing about 1 mg of ofloxacin and 1 mg of ciprofloxacin per 1 ml, which was used as a system applicable solution according to thin layer chromatography (General 0502). Test, Draw 2 u1 of each of the above three solutions, respectively point on the same silica gel GF254 thin layer plate, with ethyl acetate-methanol-concentrated ammonia solution (5:6:2) as the developing agent, expand, take out, dry, set the UV lamp (254nm or 365nm) under the view. The system applicable solution should show two completely separated spots, and 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 1003).
- two items (1) and (2) above can be selected as one item.
Last Update：2022-01-01 15:36:38
Ofloxacin Otic - Safety
Open Data Verified Data
male and female mice, male and female rats oral LDs50(mg/kg); 5450, 5290, 3590, 3750; Male and female mice, male, female rats intravenous injection of LDso(mg/kg), 208,233,273,276; Male and female mice, male and female rats subcutaneous injection of LD50(mg/kg); 10000, >10000, 7070, 9000.
Last Update：2022-01-01 09:08:59
Ofloxacin Otic - Exam
Authoritative Data Verified Data
clarity of the solution
take 5 parts of this product, each 0.5g, respectively, with sodium hydroxide solution 10ml after dissolution, the solution should be clear; If it is turbid, compared with the No. 2 Turbidity standard solution (General rule 0902 first method), none should be more concentrated.
absorbance
take this product 0.lg, precision weighing, precision plus sodium hydroxide solution 10ml dissolved, according to UV-visible spectrophotometry (General rule 0401), determination of absorbance at the wavelength of 450nm, not more than 0.25.
Related substances
take the right amount of this product, precision weighing, plus O. 1 mol/L hydrochloric acid solution was dissolved and quantitatively diluted to prepare a solution containing about 1.2mg per 1 ml as a test solution; The amount of fine energy was taken to be 0.1 mol/L hydrochloric acid solution is quantitatively diluted to prepare a solution containing about 2.4ug per 1 ml as a control solution; The appropriate amount of the control solution is accurately measured, and 0.1 mol/L hydrochloric acid solution was quantitatively diluted to obtain a solution containing about 0.24ug per 1 ml as a sensitivity solution. In addition, weigh about 18mg 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 as A control solution for impurity A. According to the high performance liquid chromatography (General 0512) test, with eighteen alkyl silane bonded silica gel as filler; Ammonium acetate sodium perchlorate solution (take ammonium acetate 4.Og and sodium perchlorate 7.0g, added with water 1300ml to dissolve, adjusted to pH 2.2 with phosphoric acid)-acetonitrile (85:15) as mobile phase A, acetonitrile as mobile phase B; the linear gradient elution was performed as follows. The flow rate was 1.0 per minute; The column temperature was 40°C. Take the right amount of ofloxacin control, ciprofloxacin control and impurity E control, and add 0.1 mol/L hydrochloric acid solution was dissolved and diluted to make a mixed solution containing about 1.2mg of ofloxacin, 6ug of ciprofloxacin and impurity E per 1 ml, and 1u1 was injected into the liquid chromatograph at 294nm as the detection wavelength, the chromatogram was recorded and the retention time of the ofloxacin peak was approximately 15 minutes. The resolution between ofloxacin peak and impurity E peak and between ofloxacin peak and ciprofloxacin peak should be more than 2.0 and 2.5, respectively. The sensitivity solution lOul was injected into the liquid chromatograph, and the detection wavelength was 294nm. The chromatogram was recorded, and the signal to noise ratio of the main component peak height should be greater than 10. The sample solution, the control solution and the impurity A reference solution were respectively injected into the liquid chromatograph, and the chromatograms were recorded with the detection wavelengths of 294nm and 238nm. If there are impurity peaks in the chromatogram of the test solution, impurity A(238nm detection) shall be calculated by the peak area according to the external standard method, and shall not exceed 0.3%; Other single impurities (294nm detection) the peak area shall not be greater than the main peak area of the control solution (0.2% ), and the sum of other impurity peak areas (294nm detection) 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.
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 it in a platinum crucible, and check it according to law (General rule 0841). The residue left shall not exceed 0.2%.
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 Principles 0821, Law II).
bacterial endotoxin
take this product, check according to law (General rule 1143), the amount of endotoxin per 1 mg of ofloxacin should be less than 0.75EU. (For injection)
Last Update：2022-01-01 15:36:39
Ofloxacin Otic - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with octanoalkyl silane as filler; Ammonium acetate sodium perchlorate solution (ammonium acetate 7.0g and sodium perchlorate 2.2g were added with water to dissolve, and the pH value was adjusted to with phosphoric acid)-Acetonitrile (85:15) as mobile phase; The detection wavelength was 294nm. Take the right amount of ofloxacin control, ciprofloxacin control and impurity E control, and add 0.1 mol/L hydrochloric acid solution is dissolved and diluted to make a mixed solution containing about 0.12mg of ofloxacin, 6ug of ciprofloxacin and impurity E per 1 ml, and 10u1 is injected into the liquid chromatograph to record the chromatogram, the retention time of the ofloxacin peak is about 15 minutes, and the resolution between the ofloxacin peak and the impurity E peak and the ofloxacin peak and the ciprofloxacin peak should be greater than 2.0 and 2.5, respectively.
assay
take this product about 60mg, precision weighing, put 50ml measuring bottle, add 0.1 mol/L hydrochloric acid solution dissolved and diluted to the scale, shake, precision take 5ml, put 50ml flask, with 0.lmol/L hydrochloric acid solution was diluted to the scale, and then shaken, used as the test solution. Lol was injected into the liquid chromatograph accurately, and the chromatogram was recorded, according to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 15:36:40
Ofloxacin Otic - Category
Authoritative Data Verified Data
quinolones.
Last Update：2022-01-01 15:36:40
Ofloxacin Otic - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 15:36:40
Ofloxacin Otic - Ofloxacin tablets
Authoritative Data Verified Data
This product contains ofloxacin (C18H20FN304) should be labeled the amount of 90.0% to 110.0%.
trait
This product is a white-like to yellowish tablet or film-coated tablet, which appears white to yellowish after removing the coating.
identification
- take an appropriate amount of fine powder of this product and add O. 1 mol/L hydrochloric acid solution (5mg per 5mg of ofloxacin plus 0.1 mol/L hydrochloric acid solution (1 ml) to dissolve ofloxacin, diluted with ethanol to prepare a solution containing about 1 mg of ofloxacin per 1 ml, filtered, and the filtrate was taken as a test solution; the same results were shown in the identification (1) Test under ofloxacin.
- 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 is dissolved and diluted to prepare a solution containing about 6 tons of ofloxacin per 1 ml, filtered, and the filtrate is determined by UV-Vis spectrophotometry (General 0401), there is a maximum absorption at a wavelength of 294nm.
- two items (1) and (2) above can be selected as one item.
examination
- Related substances take an appropriate amount of fine powder of this product, weigh it accurately, add 0.1 mol/L hydrochloric acid solution was dissolved and quantitatively diluted to make a solution containing about 1.2mg of ofloxacin per 1 ml, filtered, and the filtrate was taken as the test solution, impurity A(238nm 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 (294nm detection) shall not exceed 1.5 times (0.3%) of the main peak area of the control solution, the sum of 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.
- 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 in accordance with 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 about 4.5ug solution containing ofloxacin per lml, shake, according to UV-visible spectrophotometry (General rule 0401 ) , determine the absorbance at the wavelength of 294nm, the dissolution medium was added to dissolve and quantitatively dilute to prepare a solution containing about 4.5ug per 1 ml, which was determined by the same method, and the dissolution amount of each tablet was calculated. 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 an appropriate amount (about 0.12g equivalent to ofloxacin), put it in a 100ml measuring flask, add 0.1 mol/L hydrochloric acid solution dissolved and diluted to the scale, shake, filter, precision take the remaining filtrate 5ml, 50ml flask, with 0. The 1 mol/L hydrochloric acid solution was diluted to the scale, and was shaken to obtain a test solution, which was measured according to the method of ofloxacin.
category
with ofloxacin.
specification
(1)0.lg (2)0.2g
storage
light shielding, sealed storage.
Last Update：2022-01-01 15:36:41
Ofloxacin Otic - Ofloxacin Capsules
Authoritative Data Verified Data
This product contains ofloxacin (C18H20FN304) should be 90.0% ~ 110.0% of the label.
trait
The contents of this product are white to yellowish powder or granules.
identification
- weigh the content of this product, add 0.1 mol/L hydrochloric acid solution (5mg per 5mg of ofloxacin plus 0.1 mol/L hydrochloric acid solution (1 ml) to dissolve ofloxacin, diluted with ethanol to prepare a solution containing about 1 mg of ofloxacin per 1 ml, filtered, and the filtrate was taken as a test solution; the same results were shown in the identification (1) Test under ofloxacin.
- 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 is dissolved and diluted to make a solution containing about 6ug of ofloxacin per 1 ml, filtered, and the filtrate is taken and determined by UV-Vis spectrophotometry (General 0401), there is a maximum absorption at a wavelength of 294nm.
- two items (1) and (2) above can be selected as one item.
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 make a solution containing about 1.2mg of ofloxacin per 1 ml, filtered, and the filtrate was taken as the test solution, impurity A(238nm 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 (294nm detection) shall not exceed 1.5 times (0.3%) of the main peak area of the control solution, the sum of 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.
- 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 the law, after 30 minutes, take the appropriate amount of solution, filter, take the filtrate 2ml, put it in a 50ml measuring flask, dilute to the scale with dissolution medium, shake well, according to UV-visible spectrophotometry (General rule 0401), determine the absorbance at the wavelength of 294nm, the dissolution medium was added to dissolve and quantitatively dilute to prepare a solution containing about 4.5ug per 1 ml, which was determined by the same method, and the dissolution amount of each particle was 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 (about 0.12g equivalent to ofloxacin) accurately, put it in a measuring flask, add 0.1 mol/L hydrochloric acid solution dissolved and diluted to the scale, shake, filter, precision take the remaining filtrate 5ml, 50ml flask, with 0. The 1 mol/L hydrochloric acid solution was diluted to the scale, and was shaken to obtain a test solution, which was measured according to the method of ofloxacin.
category
with ofloxacin.
specification
O.lg
storage
light shielding, sealed storage.
Last Update：2022-01-01 15:36:42
Ofloxacin Otic - Ofloxacin Eye Ointment
Authoritative Data Verified Data
This product contains ofloxacin (C18H20FN304) should be 90.0% ~ 110.0% of the label.
trait
This product is a white to yellow ointment or an almost colorless to yellowish gel-based ointment.
identification
- take an appropriate amount of this product and add O. 1 mol/L hydrochloric acid solution is made into a solution containing about 1 mg of ofloxacin per 1 ml, heated in a water bath for 2 minutes, fully shaken, filtered, and the continued filtrate is taken as a test solution; the same results were shown in the identification (1) Test under ofloxacin.
- 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 the appropriate amount of the test solution under the content determination item, and use 0.1 mol/L hydrochloric acid solution was diluted to prepare a solution containing about 6ug of ofloxacin per 1 ml, and the maximum absorption was determined by UV-visible spectrophotometry (General 0401) at the wavelength of 294nm.
- two items (1) and (2) above can be selected as one item.
examination
should comply with the relevant provisions under Ophthalmic Preparations (General rule 0105).
Content determination
take about 2g of this product, weigh it accurately, add 40ml of petroleum ether (60~90°C), shake it, use 0.lmol/L hydrochloric acid solution was extracted by shaking for 3 times, each time 15ml, combined with the extract, put 50ml flask, with 0.1 mol/L hydrochloric acid solution diluted to the scale, shake well (suitable for Vaseline matrix), or take about 2g of this product, precision weighing, put 50ml flask, add O. 1 mol/L hydrochloric acid solution 30ml, fully shake to dissolve, with 0.1 mol/L hydrochloric acid solution diluted to the scale, shake (suitable for gel matrix), filter, take the filtrate as the test solution, according to the method under the item of ofloxacin, then get.
category
with ofloxacin.
specification
0.3%
storage
light shielding, sealed storage.
Last Update：2022-01-01 15:36:43
Ofloxacin Otic - Ofloxacin and Sodium Chloride Injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of ofloxacin and sodium chloride. The content of ofloxacin (C18H20FN304) and sodium chloride (NaCl) should be 90.0% to 110.0% of the labeled amount.
trait
This product is a light yellow green clear liquid.
identification
- take an appropriate amount of this product and dilute it with ethanol to make a solution containing about 1 mg of ofloxacin per 1 ml, as a test solution, according to the identification (1) Test under the item of ofloxacin, the same results are shown.
- 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.
- This product chloride identification (1) of the reaction (General 0301).
- This product shows the reaction of sodium salt identification (1) (General rule 0301).
- two items (1) and (2) above can be selected as one item.
examination
- the pH value should be 3.5 to 7.5 (General 0631).
- absorbance this product, according to UV-visible spectrophotometry (General 0401), at the wavelength of 450nm absorbance measurement, not over 0.03.
- precision measurement of related substances take appropriate amount of this product, use O. Quantitative dilution of 1 mol/L hydrochloric acid solution to prepare a solution containing about 1.2mg of ofloxacin per 1 ml as a test solution; Determination according to the method under the item of ofloxacin, if there are impurity peaks in the chromatogram of the test solution, impurity A(238nm detection) shall be calculated by peak area according to the standard method, and shall not: 0.3% of the amount of ofloxacin; Other single impurities (294nm detection) the peak area shall not be greater than the main peak area of the control solution (0.2% ), and the sum of other impurity peak areas (294nm detection) shall not be greater than 2.5 times (0.5%) of the main peak area of the control solution.
- take 20ml of heavy metal, put it on a water bath to dry, and check the residue according to law (General rule 0821 second law), containing no more than of heavy metals. Osmolality the osmolality ratio should be 0.9 to 1.1 (General 0632).
- bacterial endotoxin this product, according to the law to check (General 1143), the amount of endotoxin per lml should be less than 0.50EU.
- sterile take this product, after membrane filtration treatment, with 0.1% sterile peptone aqueous solution washing (not less than 500ml per membrane), each tube of culture medium with 0.1 mol/L manganese sulfate solution 1ml, with Escherichia coli as the positive control bacteria, according to the law (General rule 1101), should comply with the provisions.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
take 15ml of this product for precise measurement of ofloxacin, put it in a 25ml measuring flask, and use O. Dilute the lmol/L hydrochloric acid solution to the scale, shake well, take 5ml accurately, put it in a 50ml measuring flask, use 0. The 1 mol/L hydrochloric acid solution was diluted to the scale, and was shaken to obtain a test solution, which was measured according to the method of ofloxacin. Take 10ml of sodium chloride, add 30ml of water, add 5ml of 2% dextrin solution and 3-5 drops of fluorescein indicator solution, and titrate with silver nitrate titration solution (0.lmol/L). Each l of silver nitrate titration solution (0.1 mol/L) corresponds to 5.844mg of NaCl.
category
with ofloxacin.
specification
100ml: ofloxacin 0.2g with sodium chloride 0.9g
storage
light shielding, closed storage.
Last Update：2022-01-01 15:36:44
Ofloxacin Otic - Ofloxacin ear drops
Authoritative Data Verified Data
This product contains ofloxacin (C18H20FN304) should be labeled the amount of 90.0% to 110.0%.
trait
This product is a light yellow green clear liquid.
identification
- take an appropriate amount of this product and dilute it with ethanol to prepare a solution containing about 1 mg of ofloxacin per 1 ml as a test solution; According to the identification (1) Test under the item of ofloxacin, the same results are shown.
- 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 and use 0.1 mol/L hydrochloric acid solution was diluted to prepare a solution containing about 6ug of ofloxacin per 1 ml, and the maximum absorption was determined by UV-visible spectrophotometry (General 0401) at the wavelength of 294nm.
- two items (1) and (2) above can be selected as one item.
examination
- the pH value should be 6.0 to 7.0 (General 0631).
- absorbance this product, according to UV-visible spectrophotometry (General 0401), at the wavelength of 450nm absorbance measurement, not over 0.04.
- precision measurement of related substances take appropriate amount of this product, use O. 1 mol/L hydrochloric acid solution is quantitatively diluted to prepare a solution containing about 1.2mg of ofloxacin per 1 ml as the test solution; The appropriate amount is taken for the precise amount, and 0.1 mol/L hydrochloric acid solution is quantitatively diluted to prepare a solution containing about 2.4ug of ofloxacin per 1 ml as a control solution. 1 mol/L hydrochloric acid solution is quantitatively diluted to make A solution containing about 0.24ug of ofloxacin per 1 ml, which is used as A sensitivity solution; Another 18mg of reference substance of impurity A is accurately weighed and placed in A 100ml measuring flask, add 6mol/L ammonia solution (lml) and appropriate amount of water to dissolve, dilute to scale with water, shake well, take 2ml accurately, put it in 50ml measuring flask, dilute to scale with water, shake well, as A control solution of impurity A. If there are impurity peaks in the chromatogram of the test solution [except for the peak of ethylenediamine tetraacetic acid (relative retention time is about 0.14)] and hydroxybenzyl Ester peak (relative retention time is about 1.7), impurity A(238nm detection) according to the external standard method to calculate the peak area, not over 0.6% of the amount of labeling; Other single impurities (294nm detection) the peak area shall not be more than 2 times (0.4%) of the main peak area of the control solution, and the sum of the peak areas of other impurities (294nm detection) shall not be more than 5 times (1.0%) of the main peak area of the control solution.
- others shall comply with the relevant provisions under the item of ear preparations (General rule 0126).
Content determination
take 2ml of this product (about 6mg equivalent to ofloxacin), put it in a 50ml measuring flask, and use 0. The 1 mol/L hydrochloric acid solution was diluted to the scale, and was shaken to obtain a test solution, which was measured according to the method of ofloxacin.
category
with ofloxacin.
specification
(l)5ml:15mg (2)8ml:24mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 15:36:44
Ofloxacin Otic - Ofloxacin Eye Drops
Authoritative Data Verified Data
This product contains ofloxacin (C18H20FN304) should be labeled the amount of 90.0% to 110.0%.
trait
This product is light yellow or light yellow green clear liquid.
identification
- take an appropriate amount of this product and dilute it with ethanol to make a solution containing about 1 mg of ofloxacin per 1 ml, as a test solution, according to the identification (1) Test under the item of ofloxacin, the same results are shown.
- 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 and use 0.1 mol/L hydrochloric acid solution was diluted to prepare a solution containing about 6ug of ofloxacin per 1 ml, and the maximum absorption was determined by UV-visible spectrophotometry (General 0401) at the wavelength of 294nm.
- two items (1) and (2) above can be selected as one item.
examination
- the pH value should be 6.0 to 7.0 (General 0631).
- absorbance this product, according to UV-visible spectrophotometry (General 0401), at the wavelength of 450nm absorbance measurement, not over 0.04. The precision of the amount of related substances take this product, with O. 1 mol/L hydrochloric acid solution is quantitatively diluted to prepare a solution containing about 1.2mg of ofloxacin per 1 ml, which is used as a test solution. Quantitative dilution of 1 mol/L hydrochloric acid solution is made to contain about 2 ofloxacin per 1 ml. ug of the solution, as a control solution; Precision take the appropriate amount of control solution, with 0. A 1 mol/L hydrochloric acid solution was quantitatively diluted to obtain a solution containing about 0.24ug of ofloxacin per 1 ml as a sensitivity solution. In addition, weigh about 12mg of the reference product of impurity A accurately, put it in A 100ml measuring flask, dissolve it with 0.6mL of 6mol/L ammonia solution and an appropriate amount of water, dilute it with water to the scale, shake well, and take 2ml accurately, in A 50ml measuring flask, dilute to the scale with water, shake well, and use as A reference solution for impurity A. If there are impurity peaks [except ethylenediamine tetraacetic acid peak (relative retention time is about 0.14)] in the chromatogram of the test solution, impurity A(238nm detection) according to the external standard method, the peak area shall not exceed 0.4% of the labeled amount; The peak area of other single 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 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, is determined by HPLC (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; 0.005mol/L ammonium acetate solution (containing 10ml of triethylamine per 5.0±0.5 ml, adjusted to pH with glacial acetic acid)-Acetonitrile (35:65) as mobile phase; The detection wavelength was 214nm. The tailing factor should be less than 1.5 based on the benzalkonium bromide peak.
- determination precision measure 20ul of this product, inject it into liquid chromatograph, record the chromatogram; Another precision weigh appropriate amount of benzalkonium bromide reference substance, add water to dissolve and quantitatively dilute to make about O per lml. lmg solution, the same method for 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 2ml of this product (about 6mg equivalent to ofloxacin), put it in a 50ml measuring flask, and use 0. The 1 mol/L hydrochloric acid solution was diluted to the scale, and was shaken to obtain a test solution, which was measured according to the method of ofloxacin.
category
with ofloxacin.
specification
(1 ) 5ml:15mg ( 2 ) 8ml:24mg(3)10ml:30mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 15:36:45
Ofloxacin Otic - Reference Information
| EPA chemical substance information | information provided by: ofmpeb.epa.gov (external link) |
| Introduction | Ofloxacin (OFL) is a third-generation quinolone, it is based on the basic skeleton of the molecular structure of quinolones are nitrogen (hetero) double and ring structure, in the X - 8 position is substituted by fluorine, and increase the ring, developed by Japan first Pharmaceutical Co., Ltd. in 1982, is a broad-spectrum antibacterial drug, effective against bacteria, Mycoplasma and some anaerobic bacteria, the chemical name is (±) -9-fluoro-2, 3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7h-pyrido [1,2,3-de]- [ 1,4] benzoxazine-6-carboxylic acid, ofloxacin is yellow or gray-yellow crystalline powder, odorless, bitter, slightly soluble in water, ethanol, acetone, methanol, very soluble in glacial acetic acid. |
| indication | clinically, it is mainly used for respiratory tract, throat, tonsil and urinary tract caused by sensitive bacteria, including prostate, skin and soft tissue, acute and chronic infections of the intestinal tract and other parts of the ear and nose. |
| drug interaction | ofloxacin and other antibiotics, antipyretic analgesic, antiviral, immunomodulators are widely used in combination or developed into compound preparations. According to the market survey, some provinces and cities have approved more compound ofloxacin preparations, such as ofloxacin diclofenac sodium injection, ofloxacin Levamisole HydrochJonide Tablets, etc., to expand the antibacterial spectrum for comprehensive prevention and control, especially for other antibiotics relatively poor efficacy of Streptococcus, Pneumonia cocci, Mycoplasma, anaerobic bacteria and so on have a good effect. Common compatibility drugs are: (1) with astragalus polysaccharide, Radix isatidis or Senecio and other antiviral drugs, for bacterial, viral infection; (2) with metamizole or diclofenac sodium, ketorolac and other antipyretic analgesics, for bacterial fever; ③ with houttuynia, Bupleurum and other traditional Chinese medicine compatibility, for summer fever; ④ with metronidazole, for severe anaerobic infection; (5) with doxycycline hydrochloride, sulfa drugs, for blood protozoan disease; (6) it can be used for intestinal diseases by compatibility with Xiongjun and berberine. |
| adverse reactions | Nausea, Vomit, Diarrhea, Abdominal Pain, dizziness, hallucination, Head Pain, tremor and restlessness, facial flushing, rash, photosensitivity and anaphylactic shock may also occur. Can cause renal dysfunction (BUN increased, serum creatinine values increased), elevated transaminase, leukopenia and thrombocytopenia, dizziness, Sleep Initiation and Maintenance Disorders. Pregnant women, nursing mothers and young children are not allowed. |
| preparation | with 2,3, 4-trifluoronitrobenzene (2) as the starting material, after alkali hydrolysis, ether ketone (5) was obtained by condensation with monochloroacetone in 75 ~ 78% yield. It was reduced by Raney nickel and condensed with diethyl ethoxymethylene malonate (EMME); then the carboxylic acid (9) was obtained by cyclization with ethyl polyphosphate ( PPE) or polyphosphoric acid as cyclic agent and hydrolysis with hydrochloric acid and glacial acetic acid. The yield was about 75%; 9 was condensed with N-methylpiperazine and refined to obtain ofloxacin in 85% yield and about 50% overall yield. |
| pharmacological action | This product has the third generation quinolone antibacterial activity against Staphylococcus, Streptococcus, Pneumonia Streptococcus, Neisseria gonorrhoeae, citric acid bacteria, Shigella, Pneumonia Klebsiella, Enterobacter, Serratia, Proteus, Haemophilus influenzae, Acinetobacter, Campylobacter, pseudomonas aeruginosa and Chlamydia trachomatis also have a certain antibacterial effect, there are anti-Mycobacterium tuberculosis role, with isoniazid, rifampicin and treatment of tuberculosis. Gram-positive bacteria, negative bacteria have a strong antibacterial effect. It also has a good effect on anaerobic bacteria and Pneumonia Mycoplasma. The antibacterial activity of Staphylococcus aureus and hemolytic Streptococcus was 4~8 times stronger than that of norfloxacin. |
| Use | The third generation of quinolone synthetic antibacterial drugs, with broad antibacterial spectrum, strong antibacterial activity, good bioavailability, oral safe and effective, low toxicity, no drug resistance and other advantages. It has good antibacterial effect on many Gram-positive and gram-negative bacteria, and also has antibacterial effect on Pseudomonas aeruginosa and chlamydia. The new penicillin, clindamycin, Gentamicin-resistant strains and norfloxacin-resistant strains, the goods good role, no cross-resistance. In addition, it also has a certain antibacterial effect on anaerobic bacteria. For sensitive bacteria caused by respiratory infections, intestinal infections, skin and soft tissue infections, urinary tract infections. Nalidixic acid analogs with broad-spectrum antibacterial activity |
| production method | Method 1: 2,3, 4-trifluoronitrobenzene as the starting material, selective alkaline hydrolysis, etherification, reduction, condensation, cyclization, hydrolysis with c2h5tch = C(COOEt)2 or (CH3)2NCH = C(COOEt)2, N-methyl piperazine was then introduced to give the product. Method 2: Using phthalimide derivatives as raw materials, by fluorination to produce tetrafluorophthalimide, hydrolysis, decarboxylation to produce 2,3,4, 5-tetrafluorobenzoic acid, then chlorination, acylation, decarboxylation to produce 2, ethyl 3,4, 5-tetrafluorobenzoyl acetate, followed by reaction with triethyl orthoformate, then with 2-aminopropanol, followed by cyclization to form pyrido [1,2,3-de][1,4] benzoxazine derivatives, and finally piperazine reaction to produce ofloxacin. Method 3: The ethyl tetrafluorobenzoyl acetate obtained above is reacted with methylpiperazine first, and after the introduction of the piperazinyl group, it is cyclized after the introduction of the side chain and then hydrolyzed to obtain ofloxacin. In the preparation of ofloxacin, the introduction of piperazine group is a research hotspot. The later introduced, the greater the effect on the yield. In this method, piperazine is introduced first, and the yield of introduction can reach 88%. However, in the case of cyclization, a strong base, such as sodium hydride, must be used for cyclization. |
| toxic substance data | information provided by: pubchem.ncbi.nlm.nih.gov (external link) |
Last Update：2024-04-09 19:55:45
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View History
Ofloxacin Otic
Triethoxy(hex-5-en-1-yl)silane
Oprea1_171421
2,2,2-TRIFLUOROETHYL TRIFLUOROMETHANESULPHONATE
2090-05-3
Triethoxy(hex-5-en-1-yl)silane
Oprea1_171421
2,2,2-TRIFLUOROETHYL TRIFLUOROMETHANESULPHONATE
2090-05-3
Raw Materials for Ofloxacin Otic
2,3,4-Trifluoronitrobenzene
1-Methylpiperazine
Acetone
Methyl sulfoxide
Potassium hydroxide
Ethyl Alcohol
1-Methylpiperazine
Acetone
Methyl sulfoxide
Potassium hydroxide
Ethyl Alcohol