1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid hydrochloride monohydrate
Ciprofloxacin Monohydrochloride monohydrate
CAS: 86393-32-0
Molecular Formula: C17H21ClFN3O4
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid hydrochloride monohydrate - Names and Identifiers
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid hydrochloride monohydrate - Physico-chemical Properties
| Molecular Formula | C17H21ClFN3O4 |
| Molar Mass | 385.82 |
| Melting Point | 318-320 °C |
| Boling Point | 581.8°C at 760 mmHg |
| Flash Point | 305.6°C |
| Water Solubility | Soluble in water (35mg/ml). |
| Solubility | Easily soluble in water, slightly soluble in methanol, hardly soluble in ethanol. |
| Vapor Presure | 2.24E-14mmHg at 25°C |
| Appearance | White or yellowish crystal powder |
| Color | White to Light yellow |
| Merck | 14,2314 |
| PH | pH (25g/l, 25℃) 3.0～4.5 |
| Storage Condition | Inert atmosphere,Store in freezer, under -20°C |
| MDL | MFCD00242856 |
| Physical and Chemical Properties | White or yellowish crystalline powder. Soluble in water, methanol-soluble, difficult to dissolve in ethanol. |
| Use | Broad-spectrum antibacterial drugs, suitable for heavy mixed infection, mainly used for chronic respiratory tract, E. Coli drugs, Transmissibility rhinitis, fowl cholera, Fowl typhoid fever, etc |
| In vitro study | Ciprofloxacin (hydrochloride monohydrate) is a fluoroquinolone antibiotic, exhibiting potent antibacterial activity. Ciprofloxacin (hydrochloride monohydrate) (CIP) shows potent activity against Y. pestis with MIC 90 of 0.03 μg/mL. |
| In vivo study | Ciprofloxacin (hydrochloride monohydrate) (1 mg/L) induces glutathione-S-transferase (GST) activity, in contrast with inhibited GST and Catalase (CAT) of larvae exposed to enrofloxacin. Ciprofloxacin (hydrochloride monohydrate) (≥10 μg/L) is ecotoxic for development, growth, detoxifying, and oxidative stress enzymes in anuran amphibian larvae. In a murine model of pneumonic plague, Ciprofloxacin (hydrochloride monohydrate) (30 mg/kg, i.p.) results in a drug exposure which is similar to the drug exposure observed in human following a 500 mg dose of oral Ciprofloxacin (hydrochloride monohydrate). Intraperitoneal Ciprofloxacin (hydrochloride monohydrate) reduces the lung bacterial load compare to controls treated with intraperitoneal PBS. |
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid hydrochloride monohydrate - Risk and Safety
| WGK Germany | 3 |
| RTECS | VB1993800 |
| HS Code | 2933595960 |
| Hazard Class | IRRITANT |
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid hydrochloride monohydrate - Standard
Authoritative Data Verified Data
This product is 1-Cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid hydrochloride monohydrate. Calculated as anhydrous and solvent-free, the content of C17H18FN303 shall not be less than 88.5%.
Last Update：2024-01-02 23:10:35
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid hydrochloride monohydrate - Trait
Authoritative Data Verified Data
- This product is white to yellowish crystalline powder; Almost odorless.
- This product is dissolved in water, very slightly dissolved in methanol or ethanol; Almost insoluble in acetone, ethyl acetate or dichloromethane.
Last Update：2022-01-01 15:05:34
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid hydrochloride monohydrate - Introduction
Easily soluble in water, slightly soluble in methanol, hardly soluble in ethanol.
Last Update：2022-10-16 17:29:25
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid hydrochloride monohydrate - Differential diagnosis
Authoritative Data Verified Data
- take the appropriate amount of this product and ciprofloxacin control, respectively, plus 0.1 mol/L hydrochloric acid solution (every 5mg ciprofloxacin plus 0.1 mol/L hydrochloric acid solution 1 ml) to dissolve and dilute with ethanol to make a solution containing about 1 mg of ciprofloxacin per 1 ml as the test solution and the reference solution, add 0.1 mol/L hydrochloric acid solution (every 5mg ciprofloxacin plus 0.1 mol/L hydrochloric acid solution (1 ml) was dissolved and diluted with ethanol to prepare a mixed solution containing about 1 mg of ciprofloxacin and 1 mg of ofloxacin per 1 ml, which was used as a system applicable solution according to thin layer chromatography (General 0502). Test, draw 2M1 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, put UV light 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 is consistent with the retention time of the main peak of the control solution.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 647).
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
- two items (1) and (2) above can be selected as one item.
Last Update：2022-01-01 15:05:35
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid hydrochloride monohydrate - Exam
Authoritative Data Verified Data
acidity
take this product, add water to make a solution containing 25mg per lml, according to the law (General 0631),pH value should be 3.0~4.5.
clarity and color of solution
take this product O.lg, after dissolving by adding 10ml of water, the solution shall be clear and colorless; In case of color development, it shall not be deeper in comparison with yellow or yellow-green No. 4 standard colorimetric solution (General rule 0901 first method).
Related substances
take an appropriate amount of this product, accurately weigh, add mobile phase A to dissolve and quantitatively dilute to make A solution containing about 0.5mg per lml, as A test solution; Take an appropriate amount of precision, A solution containing about 1 ug per 1ml was prepared as A control solution by quantitative dilution with mobile phase A. An appropriate amount of the control solution was accurately taken and quantitatively diluted with mobile phase A to prepare A solution containing about 0.1g of ciprofloxacin per 1ml as A sensitivity solution. In addition, weigh about 15mg of the reference product of impurity A accurately, put it in A 100ml measuring flask, add 0.6ml of 6mol/L ammonia solution and an appropriate amount of water to dissolve, dilute it with water to the scale, shake well, and take 1ml accurately, in A 100ml measuring flask, dilute to the scale with mobile phase A, and shake to be used as A reference solution for impurity A. Silica gel bonded with eighteen alkyl silanes was used as filler, as determined by HPLC (General 0512); Mobile phase A was 0.025mol/L phosphoric acid solution-acetonitrile (87:13). (PH adjusted to 3.0±0.1 with triethylamine), mobile phase B was acetonitrile and eluted with a linear gradient at a flow rate of 1.5ml per minute. Take appropriate amounts of ofloxacin control, ciprofloxacin control and impurity I control, add mobile phase A to dissolve and dilute to prepare A mixed solution containing about 5ug of ofloxacin, 0.5mg of ciprofloxacin and 10ug of impurity I per 1 ml, 20u1 was injected into the liquid chromatograph, and the detection wavelength was 278mn. The chromatogram was recorded, and the retention time of ciprofloxacin was about 12 minutes. The resolution between the peak of ofloxacin and the peak of ciprofloxacin and the peak of ciprofloxacin and the peak of impurity I should meet the requirements. The sensitivity solution 20u1 was injected into the liquid chromatograph, and the detection wavelength was 278nm. The chromatogram was recorded. The signal to noise ratio of the peak height of the principal component chromatogram should be greater than 10. The sample solution, the control solution and the impurity A reference solution of 20 u1 were respectively injected into the human liquid chromatograph, with 278mn and 262mn as the detection wavelength, the chromatogram was recorded, impurity E, the relative retention times of the peaks of impurity B, impurity C, impurity I, and impurity D were about 0.3, 0.6, 0.7, 1.1, and 1.2, respectively. If there are impurity peaks in the chromatogram of the test solution, the impurity A ( 262nm detection) shall be calculated by the peak area according to the external standard method, and shall not exceed 0.3%. Impurities B, C, D and E (detected at 278nm) were calculated as corrected peak areas (multiplied by Correction Factors of 0.7,0.6,1.4 and 6.7, respectively), all shall not be greater than the main peak area of the control solution (0.2%); Other single impurities (278mn detection) shall not be greater than the main peak area of the control solution (0.2%); Impurities (278mn detection) the sum of peak areas after correction shall not be greater than 3.5 times (0.7%) the area of the main peak 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.
residual solvent
take about 0.2g of this product, weigh it accurately, place it in the top empty bottle, add 5ml of water accurately to dissolve it, seal it, and use it as a test solution. Accurately weigh appropriate amounts of toluene and ethanol, and quantitatively dilute with water to prepare 0.05mg toluene and 0 ethanol per 1 ml. 1 mg of the mixed solution was accurately weighed into 5ml, placed in a headspace bottle, and sealed as a reference solution. According to the determination method of residual solvent (General Principle 0861 first method), the capillary column with 5% phenyl-95% methyl polysiloxane (or similar polarity) as the stationary liquid is the column, and the column temperature is 50°C; the Headspace bottle equilibration temperature was 90°C and the equilibration time was 30 minutes. Take the reference solution into the headspace, record the chromatogram, and the separation degree between the ethanol peak and the toluene peak should meet the requirements. The test solution and the reference solution are injected in the headspace respectively, and the chromatogram is recorded. The residual amount of toluene and ethanol shall be calculated by the peak area according to the external standard method.
moisture
take this product, according to the moisture determination method (General 0832 first method 1), the moisture content should be 4.7% ~ 6.7%.
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 metals
The residue left under the item of taking the ignition residue shall not contain more than 20 parts per million of heavy metal when examined by law (General rule 0821, Law II).
Last Update：2022-01-01 15:05:35
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid hydrochloride monohydrate - 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 was used as a filler; 0.025mol/L phosphoric acid solution-acetonitrile (87:13)(pH adjusted to 3.0±0.1 with triethylamine) was used as a mobile phase; the flow rate was 1.5 per minute. The detection wavelength was 278nm; The ofloxacin control, ciprofloxacin control and impurity I control were taken in appropriate amounts, dissolved and diluted with mobile phase to prepare about 5ug of ofloxacin and ciprofloxacin per 1 ml. lmg and impurity I lOug mixed solution, take 20ul injection liquid chromatograph, record chromatogram, ciprofloxacin peak retention time is about 12 minutes, the resolution between the peak of ofloxacin and the peak of ciprofloxacin and the peak of ciprofloxacin and the peak of impurity I should meet the requirements.
assay
take an appropriate amount of this product, precision weighing, add mobile phase dissolution and quantitative dilution to make about 0. The lmg solution was used as the test solution, and 20 u1 was accurately measured. The human liquid chromatograph was injected, and the chromatogram was recorded. The content of C17H18FN3O3 in the sample was calculated by the peak area according to the external standard method.
Last Update：2022-01-01 15:05:36
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid hydrochloride monohydrate - Category
Authoritative Data Verified Data
quinolones.
Last Update：2022-01-01 15:05:36
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid hydrochloride monohydrate - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 15:05:36
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid hydrochloride monohydrate - Ciprofloxacin hydrochloride tablets
Authoritative Data Verified Data
This product contains ciprofloxacin hydrochloride by ciprofloxacin (C17H18FN303) calculated should be 90.0% to 110.0% of the label.
trait
This product is white or off-white or film-coated, white to yellowish after removal of the coating.
identification
- take an appropriate amount of fine powder of this product and add O. 1 mol/L hydrochloric acid solution (every 5mg ciprofloxacin plus 0.1 mol/L hydrochloric acid solution 1 ml) to dissolve, dilute with ethanol to make a solution containing about 1 mg of ciprofloxacin per 1 ml, filter, and take the continued filtrate as the test solution, the same results were shown in the identification (1) Test under the term ciprofloxacin hydrochloride.
- 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 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 precise weighing appropriate amount of fine powder of this product, dissolving with mobile phase A and quantitatively diluting it to make A solution containing about 0.5mg of ciprofloxacin per 1 ml, filtering, taking the continued filtrate as the test solution, according to the method of ciprofloxacin hydrochloride. Impurity A ( 262nm detection) shall be calculated by peak area according to external standard method, and shall not exceed 0.3% of the labeled amount. Impurity C ( 278nm detection) shall be calculated according to the corrected peak area (multiplied by the correction factor 0.6 ), and shall not be greater than 2.5 times (0.5%) of the main peak area of the control solution; Impurity B, D and E ( 278nm detection) shall be calculated according to the corrected peak area (multiplied by the correction factors 0.7, 1.4 and 6.7, respectively), and shall not be larger than the main peak area of the control solution (0.2%); other single impurities (278mn detection) Peak area shall not be greater than the control solution Main Peak area (0.2%); Each impurity (278mn detection) the sum of peak areas after correction shall not be greater than 3.5 times (0.7%) the area of the main peak of the control solution.
- dissolution of this product, according to the dissolution and release determination method (General 0931 second method), with 0.lmol/L hydrochloric acid solution 900ml as the dissolution medium, the rotation speed is 50 revolutions per minute, according to the operation, after 30 minutes, take the solution 10ml, filter, take the appropriate amount of filtrate, with 0. Quantitative dilution of 1 mol/L hydrochloric acid solution to make a solution containing 0401 ug of ciprofloxacin per 1 ml, according to UV-visible spectrophotometry (general), determine the absorbance at the wavelength of 277nm, the elution amount of each tablet was calculated as the absorption coefficient of C17H18FN303 was 1278. 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 fine powder appropriate amount (equivalent to ciprofloxacin 0.2g), put in 200ml measuring flask, add appropriate amount of mobile phase, shake to dissolve and dilute to scale, shake well, filter, Take 5ml of continuous filtrate precisely, put it in 50ml measuring flask, dilute to scale with mobile phase, shake well, the test solution was obtained by measurement according to the method described in the case of ciprofloxacin hydrochloride.
category
Same as ciprofloxacin hydrochloride.
specification
Based on C17H18FN303 (1)0.25g (2)0.5g
storage
light shielding, sealed storage.
Last Update：2022-01-01 15:05:37
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid hydrochloride monohydrate - Ciprofloxacin hydrochloride capsules
Authoritative Data Verified Data
This product contains ciprofloxacin hydrochloride calculated as ciprofloxacin (C17H18FN303), should be 90.0% to 110.0% of the label amount.
trait
The contents of this product are white to yellowish particles or powder.
identification
- weigh an appropriate amount of the contents of this product and add O. 1 mol/L hydrochloric acid solution (every 5mg ciprofloxacin plus 0.1 mol/L hydrochloric acid solution 1 ml) to dissolve, dilute with ethanol to make a solution containing about 1 mg of ciprofloxacin per 1 ml, filter, and take the continued filtrate as the test solution, the same results were shown in the identification (1) Test under the term ciprofloxacin hydrochloride.
- 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, add water, shake, filter, filtrate chloride identification (1) of the reaction (General 0301).
- two items (1) and (2) above can be selected as one item.
examination
- Related substances precise weighing appropriate amount of the contents of this product, adding mobile phase A to dissolve and quantitatively dilute to make A solution containing about 0.5mg of ciprofloxacin per 1 ml, filtering, taking the continued filtrate as the test solution, according to the method of ciprofloxacin hydrochloride. Impurity A(262nm detection) shall be calculated by peak area according to external standard method, and shall not exceed 0.3% of the labeled amount. Impurity C(278nm detection) shall be calculated according to the corrected peak area (multiplied by the correction factor 0.6), and shall not be greater than 2.5 times (0.5%) of the main peak area of the control solution; Impurity B, D and E(278mn test) shall be calculated according to the corrected peak area (multiplied by the correction factors 0.7, 1.4 and 6.7, respectively), and shall not be larger than the main peak area of the control solution (0.2%); other single impurities (278nm detection) Peak area shall not be greater than the main peak surface of the control solution (0.2%); Each impurity (278nm detection) the sum of peak areas after correction shall not be greater than 3.5 times (0.7%) the area of the main peak of the control solution.
- dissolution of this product, according to the dissolution and release determination method (General 0931 second method), with 0.900ml of 1 mol/L hydrochloric acid solution is the dissolution medium, and the rotation speed is 50 revolutions per minute. The operation is carried out according to law. After 30 minutes, 10ml of the solution is taken, filtered, and 2ml of the continued filtrate is taken in a precise amount, in a 100ml measuring flask, use 0.lmol/L hydrochloric acid solution diluted to the scale, shake, according to UV-visible spectrophotometry (General 0401), at the wavelength of 277nm absorbance, the amount of dissolution per pellet was calculated as an absorption coefficient of C17H18FN303 of 1278. 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 0.2g equivalent to ciprofloxacin) accurately, and put it in a 200ml measuring flask, add appropriate amount of mobile phase, shake to dissolve and dilute to scale, shake well, filter, Take 5ml of continuous filtrate accurately, put it in 50ml measuring flask, dilute to scale with mobile phase, shake well, the test solution was obtained by measurement according to the method described in the case of ciprofloxacin hydrochloride.
category
Same as ciprofloxacin hydrochloride.
specification
0.25g (based on C17H18FN3O3)
storage
light shielding, sealed storage.
Last Update：2022-01-01 15:05:38
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid hydrochloride monohydrate - Ciprofloxacin hydrochloride eye drops
Authoritative Data Verified Data
- This product contains ciprofloxacin hydrochloride calculated as ciprofloxacin (C17H18FN303), which should be 90.0% ~ 110.0% of the label amount.
- This product can be added with an appropriate amount of preservatives.
trait
This product is colorless to yellowish clear liquid.
identification
- take an appropriate amount of this product, and dilute it with ethanol to make a solution containing 1mg of ciprofloxacin per 1 ml, as a test solution, according to the identification (1) Test under the item of ciprofloxacin hydrochloride, 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).
- two items (1) and (2) above can be selected as one item.
examination
- the pH value should be 4.0 to 5.0 (General 0631).
- Related Substances: take 15ml of this product for precise measurement, and make A solution containing about 0.45mg of ciprofloxacin per lml by quantitative dilution with mobile phase A as the test solution; Take appropriate amount for precise measurement, A solution containing about 0.9ug per 1 ml was prepared as A control solution by quantitative dilution with mobile phase A. According to the method of ciprofloxacin hydrochloride. If there are impurity peaks in the chromatogram of the test solution [except for the peak with relative retention time less than 0.2 and the peak with relative retention time of about 2.75], impurity A (262nm detection) the peak area shall be calculated according to the external standard method, and 0.3% of the labeled amount shall not be exceeded. Impurity C ( 278nm detection) shall be calculated according to the corrected peak area (multiplied by the correction factor 0.6), and shall not be greater than 2.5 times (0.5%) of the main peak area of the control solution; Impurity B, D and E( 278nm detection) shall be calculated according to the corrected peak area (multiplied by the correction factors 0.7,1.4 and 6.7, respectively), and shall not be larger than the main peak area of the control solution (0.2%); other single impurities (278nm detection) Peak area shall not be greater than the control solution Main Peak area (0.2%); Each impurity (278nm detection) the sum of peak areas after correction shall not be greater than 3.5 times (0.7%) the area of the main peak of the control solution.
- benzalkonium bromide if benzalkonium bromide is used as a preservative, it is determined by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler. 005mol/L ammonium acetate solution (10ml of triethylamine per 1000ml, adjusted to pH 5.0±0.5 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. Measure 20 u1 of this product accurately, inject it into liquid chromatograph, record chromatogram; Accurately weigh appropriate amount of benzalkonium bromide reference substance, add water to dissolve and quantitatively dilute to make it contain about 0 in 1 ml. lmg solution, the same method for determination. The peak area shall be calculated according to the external standard method. If the sample contains benzalkonium bromide, it shall be 80.0% ~ 120.0% of the labeled amount. Ethylparaben, if ethylparaben is used as 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 (50:50) as mobile phase; Detection wavelength was 256Nm. Take appropriate amount of reference substance of methyl hydroxybenzoate, reference substance of ethyl hydroxybenzoate and reference substance of hydroxyphenyl propyl ester, add appropriate amount of water, heat and dissolve in water bath, let it cool, dilute with water to make mixed solution containing about 15 sides in each lml respectively, 20u1 is injected into the liquid chromatograph, and the chromatogram is recorded. The resolution between the peak of methyl hydroxybenzoate, the peak of ethyl hydroxybenzoate and the peak of propyl hydroxybenzoate shall meet the requirements.
- precision measurement: take 3ml of this product, quantitatively dilute with water to make a solution containing about 15ug of ethylparaben in each lml, take 20 u1 for precision measurement, inject human liquid chromatograph, record chromatogram; in addition, an appropriate amount of reference substance of ethylparaben was accurately weighed, added with an appropriate amount of water, heated and dissolved in a water bath, allowed to cool, and quantitatively diluted with water to prepare a solution containing about 15ug per lml, which was determined by the same method. The peak area shall be calculated according to the external standard method, and the sample containing ethylparaben shall be 80.0%-120.0% of the labeled amount.
- 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 3ml of this product (about 9mg equivalent to ciprofloxacin), put it in a 100ml measuring flask, dilute it to scale with mobile phase, shake well, and use it as a test solution, precision weighing, and mobile phase dissolved and quantitatively diluted into a solution containing 0.09mg per 1 ml, as a reference solution; According to the method under the item of ciprofloxacin hydrochloride, obtained.
category
Same as ciprofloxacin hydrochloride.
specification
by C17H18FN303 (l) 5ml:15mg(2)8ml:24Mg
storage
shade, seal, and store in a cool place.
Last Update：2022-01-01 15:05:39
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid hydrochloride monohydrate - Reference Information
| biological activity | Ciprofloxacin Hydrochloride (Ciloxan, Ceprimax, Oftacilox) is the Hydrochloride salt form of ciprofloxacin, which is an antibiotic, for the treatment of some bacterial infections. |
| purpose | This product is a broad-spectrum antibiotic. By inhibiting bacterial DNA gyrase, DNA synthesis and replication are blocked leading to bacterial death. It has strong antibacterial activity against Escherichia coli, Klebsiella and other Enterobacteriaceae. The antibacterial activity against Pseudomonas aeruginosa, Staphylococcus aureus and Pneumonia streptococcus is better than norfloxacin and pefloxacin. For sensitive bacteria caused by otitis media, otitis externa and tympanitis. Occasional middle ear pain and pruritus. broad-spectrum antibiotics, suitable for heavy mixed infection, mainly for chronic respiratory tract, E. Coli drugs, Transmissibility rhinitis, fowl cholera, Fowl typhoid, etc. The Taste of broad-spectrum antibiotics. By inhibiting bacterial DNA gyrase, DNA synthesis and replication are blocked leading to bacterial death. It has strong antibacterial activity against Escherichia coli, Klebsiella and other Enterobacteriaceae, and has better antibacterial activity against Pseudomonas aeruginosa, Staphylococcus aureus and Pneumonia Streptococcus than norfloxacin and pefloxacin. For sensitive bacteria caused by otitis media, otitis externa and periostitis. Occasional middle ear pain and pruritus. |
Last Update：2024-04-09 15:16:53
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CAS: 86393-32-0
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Product Name: Ciprofloxacin hydrochloride Visit Supplier Webpage Request for quotationCAS: 86393-32-0
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Product Name: Ciprofloxacin Monohydrochloride monohydrate Request for quotation
CAS: 86393-32-0
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: 86393-32-0
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 Specifications
Product Name: Ciprofloxacin hydrochloride Visit Supplier Webpage Request for quotationCAS: 86393-32-0
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
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