1-(((6r,7r)-7-(((2z)-(2-amino-4-thiazolyl)((1-carboxy-1-methylethoxy)imino) acetyl) amino)-2-carboxy-8-oxo-5-thia-1-azabicyclo(4.2.0) oct-2-en-3-yl)methyl)pyridinum hydroxide inner salt
Ceftazidime
CAS: 72558-82-8
Molecular Formula: C22H22N6O7S2
1-(((6r,7r)-7-(((2z)-(2-amino-4-thiazolyl)((1-carboxy-1-methylethoxy)imino) acetyl) amino)-2-carboxy-8-oxo-5-thia-1-azabicyclo(4.2.0) oct-2-en-3-yl)methyl)pyridinum hydroxide inner salt - Names and Identifiers
1-(((6r,7r)-7-(((2z)-(2-amino-4-thiazolyl)((1-carboxy-1-methylethoxy)imino) acetyl) amino)-2-carboxy-8-oxo-5-thia-1-azabicyclo(4.2.0) oct-2-en-3-yl)methyl)pyridinum hydroxide inner salt - Physico-chemical Properties
| Molecular Formula | C22H22N6O7S2 |
| Molar Mass | 546.58 |
| Solubility | Slightly soluble in water or methanol, insoluble in acetone or chloroform |
| Appearance | Colorless crystal or white powder. |
| Merck | 14,1946 |
| Storage Condition | under inert gas (nitrogen or Argon) at 2–8 °C |
| Stability | Stable, but keep refrigerated. Incompatible with strong oxidizing agents, nitric acid, permanganates, peroxides. |
| MDL | MFCD00153936 |
| Physical and Chemical Properties | Colorless crystal or white powder. Pentahydrate: C22H22N6O7S2?5H2O. [78439-06-2]. Crystalline solid. UV maximum absorption (Ph = 6):257nm(E1cm148). |
| Use | Semi-synthetic broad-spectrum cephalosporins, mainly for sensitive bacteria caused by respiratory, urinary, soft tissue system infections |
1-(((6r,7r)-7-(((2z)-(2-amino-4-thiazolyl)((1-carboxy-1-methylethoxy)imino) acetyl) amino)-2-carboxy-8-oxo-5-thia-1-azabicyclo(4.2.0) oct-2-en-3-yl)methyl)pyridinum hydroxide inner salt - Risk and Safety
| Hazard Symbols | Xn - Harmful |
| Risk Codes | R20/21/22 - Harmful by inhalation, in contact with skin and if swallowed. 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 - Wear suitable protective clothing. |
| RTECS | UU2225000 |
| HS Code | 29419000 |
1-(((6r,7r)-7-(((2z)-(2-amino-4-thiazolyl)((1-carboxy-1-methylethoxy)imino) acetyl) amino)-2-carboxy-8-oxo-5-thia-1-azabicyclo(4.2.0) oct-2-en-3-yl)methyl)pyridinum hydroxide inner salt - Reference
| Reference Show more | 1. Liu Minfang, Cao mengrui, Li Rongxu, etc. Isolation, identification and drug sensitivity analysis of salmonella from waterfowl in some areas of Guangdong province [J]. Heilongjiang Journal of Animal Science and Veterinary Medicine, 2018(10). 2. Zhang Jipei, Wei Qinglan, Tan Hualong, etc. Detection of drug resistance and β-lactam and quinolone resistance genes in Escherichia coli isolated from waterfowl [J]. Chinese Journal of Preventive Veterinary Medicine, 2016, 38(009):751-754. 3. Wei Qinglan, Zhang Jipei, Ren Tao, et al. Drug Sensitivity Analysis of Escherichia coli from waterfowl in Guangdong province [J]. Heilongjiang Journal of Animal Husbandry and Veterinary Medicine, 2015, 000(012):180-181. 4. [IF = 2.861] can Cai et al."Two new kaurane-type diterpenoids from Wedelia chinensis (Osbeck.) merr." Nat Prod Res. 2017;31(21):2531-2536 5. [IF = 4.072] Joseph Sakah Kaunda et al."Previously undescribed pyridyl-steroidal glycoalkaloids and 23S,26R-hydroxylated spirostanoid saponin from the fruits of Solanum violaceum ortega and their bioactivities."Phytochemistry. 2021 Apr;184:112656 6. [IF=4.05] Fu-Cai Ren et al."Antibacterial Prenylated p-Hydroxybenzoic Acid Derivatives from Oberonia myosurus and Identification of Putative Prenyltransferases."J Nat Prod. 2021;84(2):417-426 7. [IF=2.457] Xue-Chun Jiang et al."4,5-Seco-18-nor-ent-clerodanoids and their derivatives: Structure elucidation, synthesis and resistant reversal activities against fluconazole-resistance Candida albicans."Tetrahedron. 2020 Apr;76:131043 |
1-(((6r,7r)-7-(((2z)-(2-amino-4-thiazolyl)((1-carboxy-1-methylethoxy)imino) acetyl) amino)-2-carboxy-8-oxo-5-thia-1-azabicyclo(4.2.0) oct-2-en-3-yl)methyl)pyridinum hydroxide inner salt - Nature
Open Data Verified Data
colorless crystal or white powder, odorless or slightly specific odor. Slightly soluble in phosphate buffer (pH 6.0), slightly soluble in water or methanol, insoluble in acetone or chloroform. The product is dissolved by adding water to generate a clear liquid medicine. Due to different concentrations, the liquid medicine can be light yellow to amber. The pH value of each new solution was 6 to 8.
pentahydrate (Ceftazidime pentahy-drate) CAS accession number [78439-06-2]. White or off-white crystalline powder, odorless or slightly odorless. Slightly soluble in phosphate buffer (pH = 6.0), slightly soluble in water or formic acid, insoluble in acetone or chloroform. UV maximum absorption (pH = 6):257nm
Last Update：2024-01-02 23:10:35
1-(((6r,7r)-7-(((2z)-(2-amino-4-thiazolyl)((1-carboxy-1-methylethoxy)imino) acetyl) amino)-2-carboxy-8-oxo-5-thia-1-azabicyclo(4.2.0) oct-2-en-3-yl)methyl)pyridinum hydroxide inner salt - Quality standards-Chinese Pharmacopoeia 2005 edition
Open Data Verified Data
The content of C2z H22 Na 07 Sz shall not be less than 95.0% based on the dry product; The clarity and color of the solution shall be in accordance with the regulations; PH value, the pH value should be 3.O ~ 4.O (containing 5mg per mL of water); Pyridine content should not exceed 0.12%; Loss on drying. It was dried under reduced pressure at 60 ℃ to reduce the weight loss by 13.0% ~ is. o%; Ignition residue should not exceed 0. 2%; Containing heavy metals should not exceed 0.002%; Bacterial endotoxin, the amount of endotoxin per 1 mg ceftazidime should be less than 0. 1EU; Sterility should be as specified.
Last Update：2022-01-01 08:52:25
1-(((6r,7r)-7-(((2z)-(2-amino-4-thiazolyl)((1-carboxy-1-methylethoxy)imino) acetyl) amino)-2-carboxy-8-oxo-5-thia-1-azabicyclo(4.2.0) oct-2-en-3-yl)methyl)pyridinum hydroxide inner salt - Standard
Authoritative Data Verified Data
This product is (6R,7R ) -7-[(2-amino-4-thiazolyl)- [(l-carboxy-1-methylethoxy) imino] acetyl] amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-en-3-methylpyridine anchor inner salt pentahydrate. Calculated as dry product, containing ceftazidime (C22H22N607S2) shall not be less than 95.0%.
Last Update：2024-01-02 23:10:35
1-(((6r,7r)-7-(((2z)-(2-amino-4-thiazolyl)((1-carboxy-1-methylethoxy)imino) acetyl) amino)-2-carboxy-8-oxo-5-thia-1-azabicyclo(4.2.0) oct-2-en-3-yl)methyl)pyridinum hydroxide inner salt - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline powder; Odorless or slightly odorous.
- This product is slightly soluble in water or methanol, insoluble in acetone, and slightly soluble in phosphate buffer (pH 6.0).
absorption coefficient
take this product, precision weighing, plus phosphate buffer solution (pH 6.0) dissolved and quantitatively diluted into about 10ug solution per lml, the absorbance was measured at a wavelength of 0401 NM according to ultraviolet-visible spectrophotometry (General Rule 400), and the absorption coefficient was 430.
Last Update：2022-01-01 11:39:30
1-(((6r,7r)-7-(((2z)-(2-amino-4-thiazolyl)((1-carboxy-1-methylethoxy)imino) acetyl) amino)-2-carboxy-8-oxo-5-thia-1-azabicyclo(4.2.0) oct-2-en-3-yl)methyl)pyridinum hydroxide inner salt - Preparation Method
Open Data Verified Data
(1) with ceftazidime as raw material, after Silylation with trimethylsilyl chloride, and phosphorus pentachloride at low temperature, after treatment with lower alcohol, amorphous solid is obtained, then the compound obtained by treatment with acetonitrile and other solvents containing hydrochloric acid and (z)~ 2 (2 tert-butyl
Reaction of oxycarbonylpropan-2-oxoimino)-2-(2-benzylaminothiazol-4-yl) acetyl chloride in methylene chloride solution, after washing with water and distilling off methylene chloride, the reaction solution is treated by adding a mixed solution of dimethylformamide, formic acid and hydrochloric acid, filtering to remove the precipitate, and then adding acetone or methanol to dissolve the treated compound in water, when the pH was adjusted to isoelectric point, ceftazidime pentahydrate was precipitated.
(2)(z) a 2 (2 a tert-butoxycarbonyl propan-2-oxy imino) one 2 One (2 one three benzyl amino thiazole -4-base) acetic acid and 3-acetoxymethyl -7-amino -3-ene -4 hydroxy acid tert-butyl ester dissolved in dimethylformamide, cooled to 0 ℃, 1-hydroxybenzotriazole and dicyclohexylcarbodiimide were added sequentially. It was warmed to room temperature and stirred at room temperature for 5h and then left overnight. Filter and wash the filter cake with a small amount of diethyl ether. The washings and the filtrate were combined, diluted with water, and extracted with ethyl acetate. The extract was washed successively with water, hydrochloric acid, sodium bicarbonate solution and saturated brine, dried and concentrated. The resulting material was subjected to column chromatography to obtain an amidated product, which was dissolved in anisole, added with trifluoroacetic acid at 0 ° C., and then concentrated with stirring for 2H at room temperature. The resulting material was dissolved in ethyl acetate and extracted with saturated sodium bicarbonate solution. The pH of the extract was adjusted to 6 and ethyl acetate was added. The aqueous layer was acidified to pH 1.5 and saturated with sodium chloride and then extracted with ethyl acetate. The extracts were combined, washed with saturated brine, dried and concentrated. The resulting material was dissolved in a hot 50% aqueous solution of formic acid and allowed to stand for 2H. Diluted with water, Filtration. The filtrate was concentrated and the resulting material was redissolved in water and filtered. Decompression frozen 3 acetoxymethyl -7-[(z) a 2 (2 amino thiazole-4-yl) -2-(2-carboxypropan-2-oxyimino) acetamido] cephalospor-3-en-4-carboxylic acid. The resulting hydrolysate was added with pyridine at 80 ° C. With stirring to an aqueous solution of sodium iodide. th was reacted at 80 °c, cooled and diluted with water. Adjust the
of the reaction solution with sodium hydroxide
The pH was to 6.0 and concentrated to remove pyridine. The remaining aqueous solution was diluted with water and two drops of methyl isobutyl ketone were added and then acidified to pH = 1 with hydrochloric acid. Filter and wash the filter cake with water. The filtrate and washing solution were combined, washed with ethyl acetate, and then adjusted to pH 6.0 with 2 mol/L sodium hydroxide. After concentration, column chromatography was performed to obtain ceftazidime.
Last Update：2022-01-01 08:52:26
1-(((6r,7r)-7-(((2z)-(2-amino-4-thiazolyl)((1-carboxy-1-methylethoxy)imino) acetyl) amino)-2-carboxy-8-oxo-5-thia-1-azabicyclo(4.2.0) oct-2-en-3-yl)methyl)pyridinum hydroxide inner salt - Differential diagnosis
Authoritative Data Verified Data
- 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 718).
Last Update：2022-01-01 11:39:30
1-(((6r,7r)-7-(((2z)-(2-amino-4-thiazolyl)((1-carboxy-1-methylethoxy)imino) acetyl) amino)-2-carboxy-8-oxo-5-thia-1-azabicyclo(4.2.0) oct-2-en-3-yl)methyl)pyridinum hydroxide inner salt - Use
Open Data Verified Data
ceftazidime on the stability of p-lactamase better, in clinical rational use of drug resistance probability is low, less side effects, the third generation of broad-spectrum cephalosporins, gram-positive bacteria and negative bacteria and anaerobic bacteria strains have a strong bactericidal effect, Pseudomonas aeruginosa has high efficiency, is the only cephalosporin antibiotics can replace the aminoglycoside, so some people called the fourth generation cephalosporin antibiotics. Clinically used for serious infections caused by sensitive bacteria (such as sepsis, meningitis, bacteremia, etc.), respiratory tract infections (such as Pneumonia, bronchitis, etc.), ear, nose and throat infections, skin and soft tissue infections, urinary tract infections, gastrointestinal, biliary and abdominal infections. Bone and Joint infection, etc.
Last Update：2022-01-01 08:52:26
1-(((6r,7r)-7-(((2z)-(2-amino-4-thiazolyl)((1-carboxy-1-methylethoxy)imino) acetyl) amino)-2-carboxy-8-oxo-5-thia-1-azabicyclo(4.2.0) oct-2-en-3-yl)methyl)pyridinum hydroxide inner salt - Exam
Authoritative Data Verified Data
acidity
take this product, add water to make a solution containing 5mg per lml, according to the law (General 0631),pH value should be 3.0~4.0. The clarity and color of the solution take this product 5, each 0.6g, respectively, add sodium carbonate solution (l-100)5ml to dissolve, the solution should be clear and colorless; If it is turbid, no one shall be more concentrated than the turbidity standard liquid No. 1 (General rule 0902 method 1), and no one shall be deeper than the yellow or yellow-green standard colorimetric liquid No. 6 (General rule 0901 method 1) in case of color development.
Related substances
take this product, add mobile phase A- mobile phase B(7:93) to dissolve and dilute to prepare A solution containing about 1.2m g per 1 ml as A test solution; 1 ml was accurately measured and placed in A 100ml measuring flask, diluted to the scale with mobile phase A- mobile phase B(7:93), and shaken to obtain A control solution. According to the determination of high performance liquid chromatography (General 0512), using eighteen alkyl silane bonded silica gel as filler; Mobile phase A is acetonitrile, mobile Phase B was phosphate buffer solution (22.6G of ammonium dihydrogen phosphate was dissolved in water and diluted to 10% ML, and the pH value was adjusted to 3.9 with phosphoric acid solution), and linear gradient elution was carried out according to the following table. The column temperature was 35 deg C; The detection wavelength was 255nm. Ceftazidime reference material 60mg, 50ml flask, add O.lmol/L hydrochloric acid solution 5ml dissolved, diluted with water to the scale, shake. In the boiling water bath for 20 minutes, take out, cool, as the system applicable solution, take 20ul injection liquid chromatography, record chromatogram. The resolution between ceftazidime and its former adjacent impurity peaks should not be less than 1.5. The test solution and the control solution are accurately sampled at 20 u1 respectively, and human liquid chromatograph is injected respectively, and the chromatogram is recorded. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than 0.5 times (0.5%) of the area of the main peak of the control solution, the sum of each impurity peak area shall not be greater than 2 times (2.0%) of the main peak area of the control solution, and the impurity peaks in the chromatogram of the test solution which are smaller than 0.05 times of the main peak area of the control solution are ignored.
ceftazidime polymer
measured by size exclusion chromatography (General 0514).
chromatographic conditions and system suitability test
A glass column having an inner diameter of 1.0 to 1.4 and a column length of G-10 was filled with dextran gel (40 to um). O at pH 7.0 with 3.5% ammonium sulfate. 1 mol/L phosphate buffer [O. 1 mol/L disodium hydrogen phosphate solution -0.1 mol/L sodium dihydrogen phosphate solution (61:39)] as mobile phase A, water as mobile Phase B, the flow rate was 0.8ml per minute, the detection wavelength was 254nm. 1.5-200ul of 2000 mg/ml Blue dextran 100 solution was injected into human liquid chromatograph, and the measurement was carried out with mobile phases A and B respectively, and the chromatogram was recorded. According to the Blue dextran 2000 peak, the number of theoretical plates is not less than 500, and the tailing factor should be less than 2.0. The retention time ratio of the Blue dextran 2000 peak in the two mobile phase systems should be between 0.93 and 1.07, the ratio of the retention time of the main peak of the control solution to the polymer peak in the test solution and the Blue dextran 2000 peak in the corresponding chromatography system should be between 0.93 and. Weigh about 0.2g of ceftazidime and 20mg of sodium carbonate into a 10ml measuring flask, dissolve in 1.5mg/ml of Blue dextran 2000 solution, dilute to the mark, and shake well. 100-200ul was injected into the liquid chromatograph, and the measurement was performed with the mobile phase A, and the chromatogram was recorded. The ratio of the peak height of the polymer to the valley height between the monomer and the polymer should be greater than 1.5. In addition, the mobile phase B is used as the mobile phase, and the relative standard deviation of the peak area should not be more than 100 when the control solution is 200-5.0% u1 for 5 consecutive injections.
preparation of control solution
an appropriate amount of ceftazidime reference substance was accurately weighed, dissolved by adding water and quantitatively made into a solution containing about 0.1 mg per 1 ml.
assay
accurately weigh about 0.2g and 20mg of sodium carbonate, put it in a 10ml measuring flask, add an appropriate amount of water to dissolve it, dilute it to the scale with water, and shake it well. Immediately, 100-200u1 is accurately weighed and injected into the liquid chromatograph. The mobile phase A is used as the mobile phase for measurement, and the chromatogram is recorded. In addition, 100 ~ 200ul of the control solution was injected into the human liquid chromatograph, and the mobile phase B was used as the mobile phase for measurement, and the chromatogram was recorded. According to the external standard method to calculate the peak area of ceftazidime, the amount of polymer containing ceftazidime shall not exceed 0.3%.
pyridine
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with octylsilane as filler; Acetonitrile -0.25mol/L ammonium dihydrogen phosphate solution (57.515g of ammonium dihydrogen phosphate, dissolved in water and diluted to 300)-Water (100:600) with ammonia solution to adjust the pH value to 7.0 as the mobile phase; The flow rate was 1.0ml per minute; The detection wavelength was 254nm. The number of theoretical plates is not less than 3000 based on the pyridine peak. Take the reference solution 20u1 injection liquid chromatograph, calculate several times injection results, the relative standard deviation shall not exceed 3.0%.
preparation of reference solution
weigh about lg of pyridine precisely, put it in a 100ml measuring flask, add water to dissolve and dilute to the scale, shake well, take 10ml precisely, put it in a 100ml measuring flask, dilute it to the scale with water, shake well and store at below 15°C. Immediately before use, take 2ml, put it in a 200ml measuring flask, and dilute it to the scale with phosphate buffer solution of pH 7.0 (weigh 5.68g of anhydrous disodium hydrogen phosphate and 3.63g of potassium dihydrogen phosphate, add water to dissolve and dilute to 1000ml), shake well as a control solution.
assay
accurately weigh about 0.66g of this product, put it in a 100ml measuring flask, add the above pH 7.0 phosphate buffer solution to dissolve and dilute to the scale (store below 15°C, after completion of injection within 1 hour), shake well, take 20u1 and inject human liquid chromatograph with precision, record chromatogram; Take another reference solution, and determine with the same method. The content of pyridine in the sample was calculated by peak area according to external standard method. Not more than 0.12%.
loss on drying
take this product, at 60°C under reduced pressure drying to constant weight (General 0831), loss weight should be 13.0% ~ 15.0%.
ignition residue
l.Og of this product shall be taken and inspected according to law (General rule 0841). Residual fish shall not pass 0.2%.
Heavy Gold
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).
visible foreign body
take 5 parts of this product, each 3.0g, respectively, plus 1% sodium carbonate solution (0.45um filter) to dissolve, according to law inspection (General 0904), should comply with the provisions. (For aseptic dispensing)
insoluble particles
Take 3 parts of this product, add 1% sodium carbonate solution (filtered by 0.45um filter) to dissolve the solution containing 30mg per lml, and check according to law (General rule 0903), each lg sample containing 10um and l0um above the particle shall not exceed 6000, containing 25um and 25um above the particle shall not exceed 600. (For aseptic dispensing)
bacterial endotoxin
take this product, check according to law (General rule 1143), each 1 mg ceftazidime (according to C22H22N6O7S2) in the amount of endotoxin should be less than 0.10EU (the test article is dissolved and diluted by adding 1% endotoxin-free sodium carbonate solution to make a solution containing 80mg per 1 ml, and then diluted to the desired concentration with endotoxin test water). (For injection)
sterile
take this product, dissolve and dilute with an appropriate amount of 1% sterile sodium carbonate solution, treat it by membrane filtration method, and check it according to law (General rule 1101). (For aseptic dispensing)
Last Update：2022-01-01 11:39:32
1-(((6r,7r)-7-(((2z)-(2-amino-4-thiazolyl)((1-carboxy-1-methylethoxy)imino) acetyl) amino)-2-carboxy-8-oxo-5-thia-1-azabicyclo(4.2.0) oct-2-en-3-yl)methyl)pyridinum hydroxide inner salt - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with OCTA alkyl silane as filler; Acetonitrile-pH 7.0 phosphate buffer (weigh anhydrous disodium hydrogen phosphate 42.59g, potassium dihydrogen phosphate 27.22g, add water to dissolve and dilute to 1000ml)-Water (40:200:1760) as mobile phase; Flow rate was 1.5ml per minute; Detection wavelength was 254nm. The reference solution 20u1 was injected into the liquid chromatograph, and the chromatogram was recorded. The separation degree between the ceftazidime peak and the adjacent impurity peak should meet the requirements.
assay
weigh 0.25g of this product accurately, put it in a 250ml measuring flask, add water to dissolve ceftazidime and dilute it to the scale, shake well, take l5ml accurately and put it in a 100ml measuring flask, dilute with water to the scale, shake, as a test solution, take 20ul injection into the liquid chromatograph, record the chromatogram; Another ceftazidime reference substance, the same method, according to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 11:39:32
1-(((6r,7r)-7-(((2z)-(2-amino-4-thiazolyl)((1-carboxy-1-methylethoxy)imino) acetyl) amino)-2-carboxy-8-oxo-5-thia-1-azabicyclo(4.2.0) oct-2-en-3-yl)methyl)pyridinum hydroxide inner salt - Category
Authoritative Data Verified Data
B-lactam antibiotics, cephalosporins.
Last Update：2022-01-01 11:39:32
1-(((6r,7r)-7-(((2z)-(2-amino-4-thiazolyl)((1-carboxy-1-methylethoxy)imino) acetyl) amino)-2-carboxy-8-oxo-5-thia-1-azabicyclo(4.2.0) oct-2-en-3-yl)methyl)pyridinum hydroxide inner salt - Storage
Authoritative Data Verified Data
sealed, stored in the cool dark.
Last Update：2022-01-01 11:39:33
1-(((6r,7r)-7-(((2z)-(2-amino-4-thiazolyl)((1-carboxy-1-methylethoxy)imino) acetyl) amino)-2-carboxy-8-oxo-5-thia-1-azabicyclo(4.2.0) oct-2-en-3-yl)methyl)pyridinum hydroxide inner salt - Ceftazidime for Injection
Authoritative Data Verified Data
This product is ceftazidime with appropriate sodium carbonate or arginine as cosolvent made of sterile powder. The content of ceftazidime (in terms of calculation) shall not be less than 95.0% based on dry product, no arginine or sodium carbonate, and the content of ceftazidime (in terms) shall be 90.0%-110.0% of the label amount based on the average content.
trait
This product is white or off-white crystalline powder.
identification
- in the chromatogram recorded under the content determination of ceftazidime, 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 an appropriate amount of this product, add dilute acid, that is, bubble boiling, carbon dioxide, lead to calcium hydroxide solution, that is, white precipitation.
- This product shows the reaction of sodium salt identification (1) (General rule 0301).
- take about 25mg of this product, add 2.0ml of water to dissolve, add about 10mg of ninhydrin, heat, the solution shows blue purple. The preparation using sodium carbonate as a cosolvent is selected as items (1), (2) and (3), and the preparation using arginine as a cosolvent is selected as items (1) and (4).
examination
- the pH value of this product is determined according to the law (General rule 0631), and the pH value should be 5.0~7.5.
- the clarity and color of the solution take 5 bottles of this product, and add water according to the labeled amount to make each lml containing 0.lg solution, the solution should be clear and colorless; If it is turbid, it should not be more concentrated than the 1# turbidity standard solution (General 0902 first method); If it is colored, no deeper color shall be compared with the yellow or yellow-green standard colorimetric solution No. 6 (General rule 0901, Method 1).
- Related substances take this product, add mobile phase A- mobile phase B(7:93) according to the labeled amount, dissolve and dilute to A solution containing about 1 mg per 1 ml as the test solution, according to ceftazidime under the determination of the method should be consistent with the provisions.
- pyridine this product is dissolved in water and diluted quantitatively according to the labeled amount to make a solution containing 6mg per 1 ml, and determined according to the method under ceftazidime, the pyridine content should not exceed 0.4% of the labeled amount of ceftazidime.
- ceftazidime polymer this product is dissolved in water and quantitatively diluted according to the labeled amount to prepare a solution containing 20mg per 1 ml, and determined according to the method under ceftazidime, the amount of ceftazidime-containing polymer should not exceed 1.0% of the labeled amount.
- loss on drying: dry the product to constant weight at 60 * * C/C, and lose no more than 12.5% (including arginine) and no more than 13.5% (including sodium carbonate). (General rule 0831).
- The content uniformity shall be calculated based on the content of ceftazidime in each bottle measured under the content determination item, and shall comply with the regulations (General rule 0941).
- insoluble particles take this product, add particles according to the labeled amount and check that the water is dissolved and made to contain 0 per 1 ml. lg of the solution, checked by law (General rule 0903), the label amount is l.O g or less is converted to each l. No more than 6000 particles with lOum and 10um or more in Og sample, no more than 600 particles with 25um or more; The labeled amount is more than G (including G). No more than 6000 particles of l0um and more than 10um and no more than 600 particles of 25um and more than 25um in each sample container.
- the bacterial endotoxin of this product shall be taken and checked according to law (General rule 1143). The amount of endotoxin contained in 1 mg ceftazidime (calculated) shall be less than 0.10EU.
- sterile take this product, dissolve and dilute with appropriate solvent, after the 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
- Take 10 bottles of ceftazidime, add water to dissolve and quantitatively dilute to prepare a solution containing about 1 mg per 1 ml. Take 15ml of ceftazidime and put it in a 100ml measuring flask, the sample solution was diluted with water to a scale, shaken well, and measured according to the method of ceftazidime, and the average content of 10 vials was determined. In addition, the appropriate amount of the contents of this product is accurately weighed, dissolved with water and quantitatively diluted to make a solution containing about 0.15mg of ceftazidime (calculated by C22H22N607S2) per 1 ml, which is determined by the same method and calculated by peak area according to external standard method.
- sodium carbonate an appropriate amount of a reference sample of sodium chloride dried at l10 °C for 2 hours was accurately weighed, dissolved with water and quantitatively diluted to prepare a solution containing about 2.8mg per 1 ml. 4.0ml, 5.0ml and 6.0ml of gasification sodium solution were accurately measured and respectively placed in a 100ml measuring flask, and nitric acid 10mU was added to dilute to the scale with water, and then shaken to be used as reference solution (1), (2), (3). Accurately weigh an appropriate amount of this product (about 13mg of sodium carbonate), put it in a 100ml measuring flask, add an appropriate amount of water to dissolve it, add 10ml of nitric acid, dilute it to the scale with water, and shake it well, as a test solution. Take 10ml of nitric acid in a 100ml measuring flask, dilute with water to the scale, shake, as a blank solution. The content of sodium carbonate was calculated by measuring the absorbance of the above solution at a wavelength of 0406 NM according to Atomic Absorption Spectrophotometry (the first method of general rule 4).
- arginine was measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using dihydroxypropyl silane bonded silica gel as filler; Using acetonitrile-pH 2.0 phosphate buffer (weigh 1.15g of ammonium dihydrogen phosphate, add water to dissolve, the pH value was adjusted to 2.0 with phosphoric acid, and then diluted to 750 ml with water, mixed well) (250:) as mobile phase; The detection wavelength was 206nm. The reference solution 20u1 was injected into the liquid chromatograph, and the chromatogram was recorded. The resolution between ceftazidime peak and arginine peak should be greater than 6.0, and the tailing factor of arginine peak should not be greater than 4.0.
- determination of precision weighing the appropriate amount of the content of this product, and the mobile phase is dissolved and quantitatively diluted to prepare a solution containing about 0.05mg of arginine per 1 ml. Injection of 20ul into the liquid chromatograph with precision and recording the chromatogram; Taking the reference substance of ceftazidime and arginine, precision weighing, and adding mobile phase to make solutions containing about 0.2mg and 0.05mg per lml respectively as the reference solution, same method determination. The content of C6H14N4O in the test sample was calculated by the peak area according to the external standard method.
category
Same as ceftazidime.
specification
(1) 0.75g (2) 1.Og (3)1.Og (4)1.5g (5)2.Og (6)3.Og as C22H22N607S2.
storage
sealed, stored in the cool dark.
Last Update：2022-01-01 11:39:34
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View History
1-(((6r,7r)-7-(((2z)-(2-amino-4-thiazolyl)((1-carboxy-1-methylethoxy)imino) acetyl) amino)-2-carboxy-8-oxo-5-thia-1-azabicyclo(4.2.0) oct-2-en-3-yl)methyl)pyridinum hydroxide inner salt
Einecs 240-017-2
BOC-RS-2-氨基辛二酸
5-溴-6-氧代-6H-吡喃-3-甲酸甲酯
Bicyclo[3.1.0]hex-2-ene,4-methylene-1-(1-methylethyl)-
OTAVA-BB 1133408
acetate kinase (diphosphate)
Einecs 240-017-2
BOC-RS-2-氨基辛二酸
5-溴-6-氧代-6H-吡喃-3-甲酸甲酯
Bicyclo[3.1.0]hex-2-ene,4-methylene-1-(1-methylethyl)-
OTAVA-BB 1133408
acetate kinase (diphosphate)