uk49858
Fluconazole
CAS: 86386-73-4
Molecular Formula: C13H12F2N6O
uk49858 - Names and Identifiers
| Name | Fluconazole |
| Synonyms | uk49858 Fluconazole -1-ylmethyl)- 2,4-DIFLUORO-,1-BIS(1H-1,2,4-TRIAZOL-1-YLMETHYL)BENZYL ALCOHOL 2-(2,4-difluorophenyl)-1,3-bis(1h-1,2,4-triazol-1-yl)-2-propanol Fluconazole,2-(2,4-Difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol alpha-(2,4-difluorophenyl)-alpha-(1h-1,2,4-triazol-1-ylmethyl)-1h-1,2,4-tria 1h-1,2,4-triazole-1-ethanol,alpha-(2,4-difluorophenyl)-alpha-(1h-1,2,4-triazol A-(2,4-DIFLUOROPHENYL)-A-(1H-1,2,4-TRIAZOL-1-YLMETHYL)-1H-1,2,4-TRIAZOL-1-ETHANOL a.-(2,4-Difluorophenyl)-a-(1H-1,2,4,-triazol-1-ylmethyl)-1H-1,2 ,4-triazole-1-ethanol |
| CAS | 86386-73-4 |
| EINECS | 627-806-0 |
| InChI | InChI=1/C13H12F2N6O/c14-10-1-2-11(12(15)3-10)13(22,4-20-8-16-6-18-20)5-21-9-17-7-19-21/h1-3,6-9,22H,4-5H2 |
| InChIKey | RFHAOTPXVQNOHP-UHFFFAOYSA-N |
uk49858 - Physico-chemical Properties
| Molecular Formula | C13H12F2N6O |
| Molar Mass | 306.27 |
| Density | 1.05 |
| Melting Point | 138-140°C |
| Boling Point | 579.8±60.0 °C(Predicted) |
| Flash Point | 9℃ |
| Water Solubility | 1g/L(temperature not stated) |
| Solubility | Soluble in water (<1 mg/ml at 25 °C), ethanol (61 mg/ml at 25 °C), and DMSO (61 mg/ |
| Appearance | solid |
| Color | White to Off-White |
| Merck | 14,4122 |
| pKa | pKa 1.76±0.1(H2O t=24 I=0.1(NaCl)) (Uncertain) |
| Storage Condition | 2-8°C |
| MDL | MFCD00274549 |
| Physical and Chemical Properties | Melting point 138-140°C |
| Use | Belongs to the third generation of imidazole antifungal drugs |
uk49858 - Risk and Safety
| Risk Codes | R22 - Harmful if swallowed R36/37/38 - Irritating to eyes, respiratory system and skin. R20/21/22 - Harmful by inhalation, in contact with skin and if swallowed. R39/23/24/25 - R23/24/25 - Toxic by inhalation, in contact with skin and if swallowed. R11 - Highly Flammable |
| Safety Description | S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S36 - Wear suitable protective clothing. S36/37/39 - Wear suitable protective clothing, gloves and eye/face protection. S24/25 - Avoid contact with skin and eyes. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) S36/37 - Wear suitable protective clothing and gloves. S16 - Keep away from sources of ignition. S7 - Keep container tightly closed. |
| UN IDs | UN1230 - class 3 - PG 2 - Methanol, solution |
| WGK Germany | 3 |
| RTECS | XZ4810000 |
| HS Code | 29336990 |
uk49858 - Upstream Downstream Industry
uk49858 - Reference
| Reference Show more | 1. Ying zeqian, Zhou Lijuan, Zhao Shijing, Wang Linxiao, Wu Yajuan, He Xiaowen. Study on stability and antifungal activity of volatile oil from papaya seeds in Hainan [J]. Shi-zhen, National Medicine, 2017,28(06):1323-1325. 2. Chen Jinping, he Haichao, Cai hang, et al. Study on the correlation between the constituents of the volatile oil from the leaves and bark of yellow skin and its antifungal activity against Candida albicans in Hainan [J]. Food Research and Development, 2019(18). 3. Li-Jun Yan, Fu-Yan Zhang, Xin-Yan Lu, et al. Extraction of effective components from Huanglian Jiedu decoction and its scavenging effect on Candida albicans [J]. Journal of Animal Science and Veterinary Medicine, 2019, 046(011):3414-3421. 4. Wang Tianming, di Lei, Shi Gaoxiang, etc. Inhibitory effect of n-butanol extract from Phellinus igniarius on Candida albicans biofilm formation [J]. Journal of Anhui University of Traditional Chinese Medicine, 2019, 038(006):P.52-57. 5. [IF = 2.211] Weifeng Hao et al."Activity of chlorhexidine acid in combination with flaconazole against suspects and biofilms of Candida auris." J Infect chemotherapy. 2022 Jan;28:29 6. [IF=2.211] Weifeng Hao et al."Identification of disulfiram as a potential antifungal drug by screening small molecular libraries."J Infect Chemother. 2021 May;27:696 7. [IF=3.361] Qiang Li et al."Phosphonium-based ionic liquids as antifungal agents for conservation of heritage sandstone."Rsc Adv. 2022 Jan;12(4):1922-1931 |
uk49858 - Nature
Open Data Verified Data
white to yellowish white crystalline powder, slightly odorous, bitter. Soluble in glacial acetic acid, methanol or ethanol, insoluble in water, almost insoluble in ether. The melting point was 137-141.6 °c.
Last Update：2024-01-02 23:10:35
uk49858 - Preparation Method
Open Data Verified Data
1H-1,2,4 triazole can be obtained from formamide, hydrazine hydrate and formic acid. M-difluorobenzene can be obtained from M-phenylenediamine, followed by bromination to 2,4-= fluorobromobenzene. The magnesium was dissolved in anhydrous diethyl ether and a solution of 2,4-= fluorobromobenzene in diethyl ether was added dropwise under Ultrasonic irradiation. A solution of 1,3-= chloroacetone in diethyl ether was then added dropwise, stirred for a certain time, and glacial acetic acid and water were added. The separated organic layer was dried and concentrated. The concentrate and triazole, potassium carbonate, PEG600 were dissolved in dry ethyl acetate, refluxed, filtered, washed with water until neutral, and dried. The solvent was distilled off, and ethyl acetate-cyclohexane (1:1) was recrystallized to obtain fluconazole. Alternatively, fluconazole can be obtained by hydrolysis by reacting methyl 2, 4-= fluorobenzoate with a Grignard reagent of 1,2, 4-chloromethyl to 1,2, 4-azole.
Last Update：2022-01-01 09:08:34
uk49858 - Standard
Authoritative Data Verified Data
This product is 1 (2, 4-difluorophenyl)-a -(lH-l,2, 4-triazol-1-ylmethyl)-1H-1,2, triazol-1-yl ethanol. Calculated as the dried product, including not less than 98.5%.
Last Update：2024-01-02 23:10:35
uk49858 - Standard
Authoritative Data Verified Data
This product is 1 (2, 4-difluorophenyl)-a -(lH-l,2, 4-triazol-1-ylmethyl)-1H-1,2, triazol-1-yl ethanol. Calculated as the dried product, including not less than 98.5%.
Last Update：2024-01-02 23:10:35
uk49858 - Trait
Authoritative Data Verified Data
- This product is white or off-white crystal or crystalline powder; Odorless or microstrip specific odor.
- This product is soluble in methanol, soluble in ethanol, slightly soluble in dichloromethane, water or acetic acid, insoluble in ether.
melting point
The melting point of this product (General 0612) is 137~141°C.
Last Update：2022-01-01 13:41:03
uk49858 - Introduction
Fluconazole is a lanosterol 14 alpha demethylase inhibitor that inhibits ergosterol formation and is used to treat and prevent superficial and systemic fungal infections.
Last Update：2022-10-16 17:29:24
uk49858 - Use
Open Data Verified Data
Pfizer was developed in 1980 and was first launched in the UK in 1988. Fluorotriazole broad-spectrum antifungal agents. The antibacterial spectrum and ketoconazole are similar, long-acting, effective for deep infection fungi, strong antifungal effect, and good oral absorption. Its mechanism is to inhibit the fungal cell membrane essential components of ergosterol synthase, so that ergosterol synthesis is blocked, damage the integrity of the fungal cell wall, thereby affecting the growth and reproduction of fungi. To Candida albicans, Trichophyton, small dog, Enterococcus epinea flocculus, mouse Coccidioides, capsular histoplasmosis, Cryptococcus neoformans, aspergillus fumigatus and other fungi have a strong antibacterial effect. It can replace amphotericin B as a long-term treatment for Cryptococcus infection in AIDS patients and may be used as a therapeutic drug for pulmonary fungal infection.
Last Update：2022-01-01 09:08:35
uk49858 - Differential diagnosis
Authoritative Data Verified Data
- take an appropriate amount of this product, add the mobile phase to dissolve and dilute to prepare a solution containing about 1 mg per 1 ml as a test solution; Take an appropriate amount of fluconazole reference, add the mobile phase to dissolve and dilute to prepare a solution containing about 1 mg per 1 ml as a reference solution, and test according to the chromatographic conditions under the item of related substances, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the control solution.
- take this product, dissolve and dilute with ethanol to make a solution containing about 0401 mg per 1 ml, and measure by UV-Vis spectrophotometry (general rule), there is a maximum absorption at the wavelength of 261nm and 267nm, and a minimum absorption at the wavelength of 264nm.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 893).
Last Update：2022-01-01 13:41:04
uk49858 - Exam
Authoritative Data Verified Data
clarity of the solution
Take 20mg of this product, add water 0902 to dissolve, the solution should be clear; If it is turbid, compared with No. 1 turbidity standard solution (General rule first method), not more concentrated. (For injection)
Related substances
take an appropriate amount of this product, add the mobile phase to dissolve and dilute to make a solution containing about 10 mg per lml, as a test solution; Take an appropriate amount for precision measurement, A solution containing about 50ug per 1 ml was prepared by quantitative dilution with the mobile phase as a control solution; An appropriate amount of the control solution was taken and diluted with the mobile phase to prepare a solution containing about 5ug per 1 ml as a sensitivity solution. According to the test of high performance liquid chromatography (General rule 0512), silica gel bonded with eighteen alkyl silane was used as the filler (4.6 x 0.063%, 5um or equivalent column); Acetonitrile-ammonium formate solution (20:80) as mobile phase; The detection wavelength was 260nm; The column temperature was 40 degrees C. Take the appropriate amount of fluconazole and impurity I control, and add the mobile phase to dissolve and dilute to make each 1 ml containing about 1 mg and 0. The solution of lmg is used as the system applicable solution, and 20ul is injected into the liquid chromatograph to record the chromatogram. The retention time of fluconazole peak is about 10 minutes, and the impurity I Peak (relative retention time is about 0.9) the degree of separation from the fluconazole peak should be met. The sensitivity solution 20u1 is injected into the human liquid chromatograph, and the signal-to-noise ratio of the peak of the main component should be greater than 5; The sample solution and the control solution should be accurately measured at 20 u1 respectively, and the human liquid chromatograph should be injected respectively, the chromatogram was 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 the area of the main peak of the control solution (0.5% ) , and the sum of each impurity peak area shall not be greater than 2 times the area of the main peak of the control solution (1.0%).
chlorine-containing compounds
take about 20mg of this product, precision weighing, according to the oxygen bottle combustion method (General 0703) for organic destruction, 0.4% sodium hydroxide solution 20ml as the absorption liquid, once the absorption is complete, shake vigorously for 5 minutes, Add 10ml of dilute nitric acid and move to 50ml Nessler's colorimetric tube, and check with the control solution (same method as the test sample) according to the chloride inspection method (General 0801), however, the test article is not contained in the filter paper during combustion, and compared with standard sodium chloride solution 6.oml), it should not be more concentrated (0.3%).
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 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 13:41:05
uk49858 - Content determination
Authoritative Data Verified Data
take this product about O.lg, precision weighing, add 50ml of glacial acetic acid to dissolve, according to the potentiometric titration method (General 0701), with perchloric acid titration solution (O. 1 mol/L) titration, and the results of the titration were corrected with a blank test. Each 1 ml of the high acid titration solution (0.1 mol/L) corresponds to 15.31mg of C13H12F2N60.
Last Update：2022-01-01 13:41:06
uk49858 - Category
Authoritative Data Verified Data
antifungal drugs.
Last Update：2022-01-01 13:41:06
uk49858 - Storage
Authoritative Data Verified Data
sealed and stored in a dry place.
Last Update：2022-01-01 13:41:06
uk49858 - Fluconazole tablets
Authoritative Data Verified Data
This product contains fluconazole (C13H12F2N60) should be labeled the amount of 90.0% to 110.0%.
trait
This product is white or white-like tablets or film-coated tablets, white or white-like after removing the coating.
identification
- 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, dissolve it with ethanol and dilute it to make a solution containing 0401 mg of fluconazole per lml, filter it, and take the filtrate according to UV-Vis spectrophotometry (general rule). It was determined that there was a maximum absorption at a wavelength of 261nm and 267mn, and a minimum absorption at a wavelength of 264nm.
examination
- relevant substances: take an appropriate amount of the fine powder of this product, add the mobile phase to dissolve and dilute to prepare a solution containing about 1 mg of fluconazole per 1 ml, filter, and take the continued filtrate as the test solution; an appropriate amount was taken in a precise amount and quantitatively diluted with the mobile phase to prepare a solution containing about 10ug per 1 ml as a control solution. According to the chromatographic conditions under the content determination item, 20 u1 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 2 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%).
- dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), hydrochloric acid solution (9-1000)500ml(50mg specification) or 1000ml (Mg, 100mg specification) as the dissolution medium, speed of 0401 rpm, according to the operation, after 45 minutes, take the solution filtration, take the filtrate, according to UV-visible spectrophotometry (general rule) determine the absorbance at 261mn wavelength; Take an appropriate amount of fukangwa reference product, weigh it precisely, add dissolution medium to dissolve and quantitatively dilute it to make it contain about 0 in 1 ml. The solution of 1 mg was measured 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
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Methanol-phosphate buffer (pH 7.0 x 45:55) as mobile phase; The detection wavelength was 261nm. The number of theoretical plates shall not be less than 1500o calculated from the fluconazole peak.
- determination of 20 tablets of this product, precision weighing, fine grinding, precision weighing take appropriate amount (about 50mg equivalent to Fu Kang WA), put in a 100ml measuring flask, adding mobile phase to shake to dissolve fluconazole and dilute to the scale, shake well, filter, take the filtrate as a test solution, take 20 u1 accurately, inject human liquid chromatograph, record the chromatogram; another fluconazole reference substance was precision weighed, dissolved and quantitatively diluted with mobile phase to make a solution containing about 0.5mg per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.
category
Same as fluconazole.
specification
(l)50mg (2)100mg (3)150mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 13:41:07
uk49858 - Fluconazole injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of fluconazole. The fluconazole content (C13H12F2N60) shall be between 90.0% and 110.0% of the labeled amount.
trait
This product is a clear colorless liquid.
identification
- 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 this product and dilute it with water to make a solution containing about 0401 mg of fluconazole per 1 ml, and measure it by UV-Vis spectrophotometry (general rule), maximum absorption at 261nm and 267nm, minimum absorption at 264nm
examination
- the pH value should be 4.0 to 8.0 (General 0631).
- appropriate amount of related substances should be taken and diluted with mobile phase to prepare a solution containing 10 mg of fluconazole per 1 ml as a sample solution, A solution containing about 50ug of fluconazole per 1 ml was prepared by quantitative dilution with mobile phase as a control solution; An appropriate amount of the control solution was taken and diluted with mobile phase to prepare a solution containing about 5ug of fluconazole per 1 ml as a sensitivity solution. According to the chromatographic conditions under the content determination item, the sensitivity solution 20u1 is injected into the liquid chromatograph, and the signal-to-noise ratio of the main component peak height should be greater than 5; then 20ul of the test solution and the control solution are accurately measured, and the human liquid chromatograph is injected 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 the area of the main peak of the control solution (0.5%), and the sum of each impurity peak area shall not be greater than 2 times the area of the main peak of the control solution (1.0%).
- the bacterial endotoxin of this product is taken and checked according to law (General rule 1143). The amount of endotoxin in fluconazole per 1 mg should be less than 0.37EU.
- sterile take this product, dilute with 0.1% sterile peptone aqueous solution to prepare a solution containing about 20mg of fluconazole per 1 ml, and treat it by membrane filtration. The drug loading of fluconazole per membrane is not more than 2g, wash with 0.1% sterile peptone aqueous solution (not less than 500ml per membrane), use Candida albicans as positive control bacteria, check according to law (General rule 1101), should comply with the regulations.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica as filler 4.6mm X 25Omm,5um or equivalent chromatographic column); Acetonitrile-0.063% ammonium formate solution (20:80) as mobile phase; The detection wavelength was 260nm; Column temperature 40°C. Take appropriate amount of fluconazole and impurity I control, add mobile phase to dissolve and dilute to make about 1 mg and 0 respectively per 1 ml. The solution of lmg is used as the system applicable solution, and 20ul is injected into the human liquid chromatograph, and the chromatogram is recorded. The retention time of fluconazole peak is about 10 minutes, and the impurity I Peak (relative retention time is about 0.9) the degree of separation from the fluconazole peak should be met.
- determination precision: take an appropriate amount of this product and quantitatively dilute it with mobile phase to make a solution containing about 1 mg of fluconazole per 1 ml. As a test solution, take 20u1 injection of human liquid chromatograph for precision measurement, record the chromatogram; Accurately weigh the appropriate amount of fluconazole reference substance, add mobile phase to dissolve and quantitatively dilute to prepare a solution containing about 1 mg per 1 ml. According to the external standard method to calculate the peak area, that is.
category
Same as fluconazole.
specification
(l)5ml:0.lg (2)5ml:0.2g (3) 10ml:O.lg
storage
light shielding, closed storage.
Last Update：2022-01-01 13:41:08
uk49858 - Fluconazole Capsules
Authoritative Data Verified Data
The fluorine-containing Kangwa (C13H12F2N60) should be 90.0% ~ 110.0% of the labeled amount.
trait
The content of this product is white or off-white powder.
identification
- take an appropriate amount of this product (about 0.1g of ziconazole), add 10ml of methanol, shake to dissolve fluconazole, filter, and take the filtrate as the test solution; another fluconazole control substance (0.1g) was dissolved in methanol (10ml) as a control solution. According to the thin layer chromatography (General 0502) test, absorb the above two solutions of 10 u1, respectively, on the same silica gel GF 254 thin layer plate, with dichloromethane-methanol-concentrated ammonia solution (80:20:1) for the development of the agent, expand, dry, set the UV light (254mn) under the inspection. The position and color of the main spot displayed by the test solution should be the same as that of the reference solution.
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
- take an appropriate amount of the contents of this product, add ethanol to dissolve and dilute to make a solution containing about 0401 mg of fluconazole per lml, filter, take the filtrate, according to UV-visible spectrophotometry (general rule) it was determined that there was a maximum absorption at the wavelengths of 261mn and 267mn and a minimum absorption at the wavelength of 264nm.
- two items (1) and (2) above can be selected as one item.
examination
- the contents under the item of difference in loading amount of related substances should be extracted finely, weighed accurately, dissolved and diluted with mobile phase to prepare a solution containing about 1 mg of fluconazole per 1 ml, filtered, the filtrate was taken as the test solution, and an appropriate amount was quantitatively diluted with the mobile phase to prepare a solution containing about 10% per 1 ml as a control solution. According to the chromatographic conditions under the content determination item, 20ul of each of the test solution and the control solution is accurately measured and injected into the liquid chromatograph respectively, and the chromatogram is recorded to 2 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%).
- dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), hydrochloric acid solution (9-1000)500ml(50mg specification) or 1000ml (Mg, 100mg specification) for the dissolution medium, speed of 0401 rpm, according to the law, after 45 minutes, take the solution filtration, take the filtrate, according to UV-visible spectrophotometry (general), the absorbance was measured at the wavelength of 261mn, and an appropriate amount of fluconazole control was taken, precisely weighed, dissolved and quantitatively diluted with dissolution medium to make about 0 in 1 ml. The solution of 1 mg was measured 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
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Methanol-phosphate buffer (pH 7.0x 45:55) as mobile phase; The detection wavelength was 261mn. The number of theoretical plates is not less than 2000 based on the fluconazole peak.
- the content under the item of difference in loading amount was measured, ground finely, and the appropriate amount (about 50mg equivalent to fluconazole) was accurately weighed and placed in a 100ml measuring flask, add mobile phase shaking to dissolve fluconazole and dilute to the scale, shake, filter, take the filtrate as a test solution, take 20ul precision, inject into the liquid chromatograph, record the chromatogram; another fluconazole reference substance was precision weighed, dissolved with mobile phase and quantitatively diluted to make a solution containing about 0.5mg per 1 ml, which was determined by the same method and calculated by peak area according to external standard method.
category
Same as fluconazole.
specification
(l)50mg (2)100mg (3)150mg
storage
sealed and stored in a dry place.
Last Update：2022-01-01 13:41:09
uk49858 - Fluconazole and Sodium Chloride Injection
Authoritative Data Verified Data
This product is an isotonic sterile aqueous solution of fluconazole and sodium chloride. The contents of fluconazole (C13H12F2N60) and sodium chloride (NaCl) shall be 95.0% to 105.0% of the labeled amount.
trait
This product is a clear colorless liquid.
identification
- 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 this product and dilute it with water to make a solution containing about 0401 mg of fluconazole per 1 ml, and measure it by UV-Vis spectrophotometry (general rule), there is a maximum absorption at the wavelength of 261nm and 267nm, and a minimum absorption at the wavelength of 264nm.
- This product sodium salt identification (1) reaction and chloride identification (1) reaction (General rule 0301).
examination
- the pH value should be 4.0 to 6.0 (General 0631).
- Related substances take this product and dilute it with mobile phase to make a solution containing 1 mg of fluconazole per 1 ml, which is used as a test solution, and take an appropriate amount with precision, A solution containing 10ug of fluconazole per 1 ml was prepared as a control solution by quantitative dilution with mobile phase. According to the chromatographic conditions under the content determination item, 20 u1 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 2 times of the retention time of the main component peak. If there are impurity peaks (except sodium chloride peaks) in the chromatogram of the test solution, the sum of the peak areas of each impurity shall not be greater than the main peak surface of the control solution (1.0%).
- take 50ml of heavy metal, evaporate to about 3.5, let it cool, add 2ml of acetate buffer (pH 0821) and an appropriate amount of water to make 25ml, and check it according to law (General rule first law), heavy metals should not exceed three million.
- 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, 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
- fluconazole was measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Methanol-phosphate buffer solution (pH 7.0X45:55) as mobile phase; The detection wavelength was 260nm. The number of theoretical plates is not less than 2000 based on the fluconazole peak.
- determination of precision take appropriate amount of this product, quantitative dilution with mobile phase to make a solution containing fluconazole 0.5mg per 1 ml, as a test solution, take 20 u1, note human liquid chromatograph, record chromatogram; Take the right amount of fluconazole reference substance, precision weighing, and mobile phase dissolution and quantitative dilution of 0.5mg per lml solution, the same method for determination. According to the external standard method to calculate the peak area, that is.
- sodium chloride precision take 10ml of this product, add water to 50ml, 2% dextrin solution 5ml, calcium carbonate 0.lg and fluorescent yellow indicator solution 5~8 drops, with silver nitrate titration solution (O.lmol/L) titration. Each 1 ml of silver nitrate titration solution (0.1 mol/L) corresponds to 5.844mg of NaCl.
category
Same as fluconazole.
specification
- 50ml: fluconazole O.lg with sodium chloride 0.45g
- 100ml fluconazole 0.lg with sodium chloride 0.9g
- 100ml: fluconazole 0.2g and sodium chloride 0.9g
storage
light shielding, closed storage.
Last Update：2022-01-01 13:41:11
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