T-1551
Cefoperazone sodium
CAS: 62893-20-3
Molecular Formula: C25H28N9NaO8S2
T-1551 - Names and Identifiers
T-1551 - Physico-chemical Properties
| Molecular Formula | C25H28N9NaO8S2 |
| Molar Mass | 669.66 |
| Melting Point | 200-202°C |
| Water Solubility | Soluble in water. Slightly soluble in alcohol. |
| Solubility | H2O: 50mg/mL, clear, faintly yellow |
| Appearance | powder |
| Color | White to Off-White |
| Merck | 13,1943 |
| BRN | 4902135 |
| Storage Condition | Inert atmosphere,2-8°C |
| Stability | Hygroscopic |
| Use | This product is for scientific research only and shall not be used for other purposes. |
T-1551 - Risk and Safety
| Hazard Symbols | Xn - Harmful |
| Risk Codes | 42/43 - May cause sensitization by inhalation and skin contact. |
| Safety Description | S22 - Do not breathe dust. S36/37 - Wear suitable protective clothing and gloves. |
| WGK Germany | 2 |
| RTECS | XI0374000 |
| HS Code | 29419000 |
T-1551 - Reference
| Reference Show more | 1. [IF=5.396] Na Li et al."Human milk and infant formula modulate the intestinal microbiota and immune systems of human microbiota-associated mice."Food Funct. 2021 Mar;12(6):2784-2798 2. [IF=5.279] Na Li et al."Cow, Goat, and Mare Milk Diets Differentially Modulated the Immune System and Gut Microbiota of Mice Colonized by Healthy Infant Feces."J Agr Food Chem. 2020;68(51):15345–15357 3. [IF=2.629] Xu Wenfeng et al."Arsenic Accumulation of Realgar Altered by Disruption of Gut Microbiota in Mice."Evid-Based Compl Alt. 2020;2020:8380473 |
T-1551 - Standard
Authoritative Data Verified Data
This product is (6R,7R)-3-[(l-methyl -1, tetrazol-5-yl) thio] methyl]-7-[(R)-2-(4-ethyl-2, 3-dioxo-1-piperazinecarylamino)-2-(p-hydroxyphenyl)-acetamido]-8-oxo-5-thia-1-azabicyclo [4.2.0] octyl-2-alkyl-2-carboxylate sodium salt. Calculated as anhydrous, containing cefoperazone (C25H27N9O8S2) shall not be less than 88.0%.
Last Update：2024-01-02 23:10:35
T-1551 - Trait
Authoritative Data Verified Data
- This product is a white to yellowish powder or crystalline powder; Odorless; With hygroscopicity.
- This product is soluble in water, slightly soluble in methanol, very slightly soluble in ethanol, insoluble in acetone or ethyl acetate.
specific rotation
take this product, precision weighing, add water to dissolve and quantitatively dilute to make a solution containing about 10 mg per lml, and determine according to law (General 0621), the specific rotation is -15 ° to -25 °.
Last Update：2022-01-01 11:40:54
T-1551 - Differential diagnosis
Authoritative Data Verified Data
- take about 0.5g of this product, add 5ml of water to shake to dissolve it, and dilute it with 75% ethanol to prepare a solution containing 10 mg of cefoperazone per 1 ml as a test solution; another appropriate amount of cefoperazone reference substance was dissolved by adding an appropriate amount of pH 7.0 phosphate buffer solution, and diluted with 75% ethanol to prepare a solution containing 10 mg of cefoperazone per 1 ml as a reference solution; the cefoperazone control and cefazolin control were dissolved in appropriate amount by adding pH 7.0 phosphate buffer solution and diluted with 75% ethanol to prepare a solution containing 10 mg of each of cefoperazone and cefazolin per 1 ml, as a system suitability solution. According to the thin layer chromatography (General 0502) test, absorb the above three solutions each 2 u1, respectively, on the same silica gel GF254 thin layer plate, with ethyl acetate-acetone-acetic acid-water (5:2:2:1) for the development of the solvent, expand, dry, first set the UV lamp 254nm, then set the iodine vapor color. The system suitability solution should show two clearly separated spots; The position and color of the main spot displayed by the test solution should be the same as the main spot of the control solution.
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 1089).
- This product shows the reaction of sodium salt identification (1) (General rule 0301).
- above (1), (2> two items can be done.
Last Update：2022-01-01 11:40:55
T-1551 - Exam
Authoritative Data Verified Data
acidity
take this product, add water to make a solution containing about 0.25g of cefoperazone per lml, and determine it according to law (General rule 0631). The pH value should be 4.5~6.5.
clarity of the solution
take 5 parts of this product, each 0.6g, respectively, add water 0902 to dissolve, the solution should be clear; If it is turbid, compare with No. 1 turbidity standard solution (General rule first method), none should be more concentrated.
absorbance
take about lg of this product, weigh it accurately, put it in a 10ml measuring flask, add water to dissolve it and dilute it to the scale, shake it well, and use UV-Vis spectrophotometry (General rule 0401), the absorbance was measured at a wavelength of 430nm and should not exceed 0.15.
Related substances
take this product, precision weighing, adding mobile phase to dissolve and quantitatively dilute to make a solution containing about 0.5mg per lml, as a test solution; Take lml with precision, in A 100ml measuring flask, dilute to the scale with mobile phase, shake well, and use as A control solution, the mobile phase was added to dissolve and quantitatively dilute to prepare a solution containing 15ug per 1 ml as an impurity control solution. According to the chromatographic conditions under the content determination item, the sample solution, the impurity reference solution and the control solution are accurately measured to 20 u1 respectively, and the human liquid chromatograph is injected respectively, the chromatogram was recorded to 4 times the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the peak area of impurity A shall not exceed 3.0% based on the external standard method, and the peak area of other individual impurities shall not be greater than 2 times (2.0%) of the main peak area of the control solution, the sum of other impurity peak areas shall not be greater than 3 times (3.0%) of the main peak area of the control solution, and the peaks in the chromatogram of the test solution which are smaller than 0.1 times of the main peak area of the control solution are ignored.
cefoperazone polymer
measured by size exclusion chromatography (General 0514).
chromatographic conditions and system suitability test
A glass column having an inner diameter of 120 to 1.0 and a column length of 30 to 40cm was filled with dextran gel G-10(40 to 1.4/Lon). At pH 7.0 0.lmol/L phosphate buffer [0.1 mol/L disodium hydrogen phosphate solution-O. 1 mol/L sodium dihydrogen phosphate solution (61:39)] as mobile phase A, water as mobile Phase B, the flow rate was about 1.5ml per minute; The detection wavelength was 254nm. Take 2000~100 u1 of 1 mg/ml Blue dextran 200 solution and inject it into human liquid chromatograph. Determine with mobile phase A and B respectively, and record chromatogram. According to the calculation of Blue dextran 2000 peak, the number of theoretical plates is not less than 300, and the tailing factor should be less than 2.0. The ratio of the retention time 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 1.07. Weigh cefoperazone sodium about 0.2g, put it in a 10ml measuring flask, add 1 mg/ml Blue dextran 2000 solution to dissolve and dilute to the scale, shake well. Measure 100-200ul and inject it into human liquid chromatograph, measure with mobile phase A, and record chromatogram. The ratio of the peak height of the polymer to the valley height between the monomer and the polymer should be greater than 2.0. 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 cefoperazone reference substance was precisely weighed, dissolved with water and quantitatively diluted to prepare a solution containing about 0.1 mg of cefoperazone per 1 ml.
assay
take about 0.2g of this product, weigh it accurately, put it in a 10ml measuring flask, add water to dissolve and dilute it to the scale, shake it well. Immediately, 100-200ul was injected into the human liquid chromatograph, and the mobile phase A was used as the mobile phase for measurement, and the chromatogram was 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 to record the chromatogram. According to the external standard method to calculate the peak area of cefoperazone, the amount of polymer containing cefoperazone should not exceed 0.4%.
residual solvent
determined as residual solvent assay (General 0861).
chromatographic conditions and system suitability test
A capillary column with 100% dimethyl polysiloxane (or similar polar) as the stationary liquid was used as the chromatographic column, and the column temperature was 40°C for 15 minutes, and the inlet temperature was 200°C, the detector temperature was 250°C, the headspace bottle equilibration temperature was 70°C, and the equilibration time was 30 minutes. The applicable solution of the system is injected in the headspace, and the peaks are obtained in the order of acetonitrile, acetone, isopropanol and butanone (internal standard>). The resolution between the peaks of acetonitrile, acetone and isopropanol shall meet the requirements. Preparation of internal standard solution the appropriate amount of methyl ethyl ketone was weighed and diluted with water to prepare a solution containing about 200ug per 1 ml as the internal standard solution.
System suitability solution preparation
the appropriate amount of acetonitrile, acetone and isopropyl alcohol was weighed and diluted with internal standard solution to prepare a solution containing 500ug of acetone, isopropyl alcohol and 40ug of acetonitrile per 1 ml; 5ml for precise measurement, top empty bottle, sealed, as the system applicable solution.
preparation of test solution
take this product about l. Add internal standard solution to dissolve and dilute to the scale. Shake well to be used as test solution (1). 2ml of each of the test solution (1) and the internal standard solution were accurately measured, placed in a headspace bottle, and sealed to serve as a test solution.
preparation of reference solution
a control solution was prepared according to the specific test object determined by the experiment. The appropriate amount of each solvent is accurately weighed and diluted quantitatively with the internal standard solution to prepare the solution of the specified concentration as the mixed reference solution, the concentration of each solvent in the mixed reference solution was 2mg of acetone per 1 ml, 0.5mg of ethanol, isopropyl alcohol, n-butyl alcohol, ethyl acetate, methyl isobutyl ketone, methanol, 0.3mg each of cyclohexane, 70Hg of tetrahydrofuran, 60ug of dichloromethane, and 41g of acetonitrile; 2ml each of the mixed reference solution and the test solution (1) were accurately measured and placed in an empty bottle at the top and sealed, as a control solution.
assay
first take the methane gas headspace injection, record the retention time of methane as the dead time (to) of the chromatographic system; Then take the test solution headspace injection, record the chromatogram, if there are chromatographic peaks in the chromatogram of the test solution, calculate the relative adjusted retention time (RART) of retention time (tR) of each chromatographic peak with respect to butanone retention time [(tr)] According to the following formula: compare the obtained RART value with the attached RART value to determine the type of residual solvent in the test sample; Prepare the corresponding reference solution, take the headspace injection of the reference solution, record the chromatogram, according to the standard addition method, the residual amount of acetone shall not exceed 2.0%, ethanol, isopropanol, n-propanol, n-butanol, ethyl acetate, methyl isobutyl ketone, methanol, cyclohexane, Tetrahydrofuran, the residual amount of two gas methane and acetonitrile shall be in accordance with the regulations.
moisture
take this product, according to the determination of moisture (General 0832 first method 1), the water content shall not exceed 5.0%.
Heavy metals
This product l.Og, inspection according to law (General Principles 0821 second law), containing heavy metals shall not exceed 10 parts per million.
visible foreign body
take 5 parts of this product, each 3.0g, plus particle inspection water dissolution, inspection according to law (General 0904), should comply with the provisions. (For aseptic dispensing)
insoluble particles
Take 3 parts of this product, and add the particle inspection water to make a solution containing 30mg per 1 ml, and check according to law (General rule 0903), no more than 6000 particles per lg of particles containing lOum and more than 10um, and no more than 600 particles containing 25um and more than 25um. (For aseptic dispensing)
bacterial endotoxin
take this product, check according to law (General rule 1143), each 1 mg of cefoperazone containing endotoxin amount should be less than 0.050EU. (For injection)
sterile
take this product, dissolve and dilute with appropriate solvent, after membrane filtration treatment, inspection according to law (General rule 1101), should comply with the provisions. (For aseptic dispensing)
Last Update：2022-01-01 11:40:56
T-1551 - Content determination
Authoritative Data Verified Data
take this product, according to cefoperazone under the method of determination, that is obtained.
Last Update：2022-01-01 11:40:57
T-1551 - Category
Authoritative Data Verified Data
B-lactam antibiotics, cephalosporins.
Last Update：2022-01-01 11:40:57
T-1551 - Storage
Authoritative Data Verified Data
seal, cold preservation.
Last Update：2022-01-01 11:40:57
T-1551 - Cefoperazone sodium for injection
Authoritative Data Verified Data
This product is sterile powder or sterile lyophilized product of cefoperazone sodium. Calculated as anhydrous, containing cefoperazone (C25H27N908S2) shall not be less than 88.0%; Calculated as the average loading, containing cefoperazone (C25H27N9O8S2) should be 95.0% ~ 105.0% of the label amount.
trait
This product is white to yellowish crystalline powder or freeze-dried block or powder; Odorless; Crystalline powder has hygroscopicity, freeze-dried product is easy to wet.
identification
According to the identification test of cefoperazone sodium, the same results were obtained.
examination
- clarity of solution take 5 bottles of this product, and add water separately according to the label. lg of the solution, the solution should be clear; If it is turbid, compared with No. 1 turbidity standard solution (General 0902 first method), shall not be more concentrated.
- absorbance: take an appropriate amount of this product (about equivalent to lg of cefoperazone), weigh it accurately, put it in a 10ml measuring flask, dissolve it with water, dilute it to the scale, and shake it well. UV-visible spectrophotometry (General rule 0401), measured at a wavelength of 430nm absorbance, not more than 0.15.
- Related substances take this product and check it according to the method under cefoperazone sodium. The content of impurity A shall be calculated by external standard method based on peak area, and shall not exceed 3.5% of the labeled amount, other single impurity peak area shall not be greater than 2.5 times (2.5%) of the main peak area of the control solution, and the sum of other impurity peak areas shall not be greater than 3.5 times (3.5%) of the main peak area of the control solution.
- the content of cefoperazone polymer under the difference item is appropriate, precision weighing, according to the method of cefoperazone sodium, according to the standard method to calculate the peak area of cefoperazone, the amount of the polymer containing cefoperazone should not exceed 0.8% of the labeled amount.
- insoluble particles take this product, and add the particle inspection water to prepare a solution containing about 30mg per 1 ml according to the label amount, and check according to law (General rule 0903), and the label amount is l. The conversion below Og is per l. No more than 6000 particles with lOum or more and no more than 600 particles with 25um or more than 25um1 in the Og sample; The labeled amount is l.O g or more (including l.Og) no more than 6000 particles of 10um and lOum in each sample container, and no more than 600 particles of 25um and 25um.
- acidity, moisture, fine endotoxin and sterility take this product, according to the method under the item of cefoperazone sodium inspection, should comply with the provisions.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
The contents under the item of loading amount difference were accurately weighed and the appropriate amount was measured according to the method under the item of cefoperazone.
category
with cefoperazone sodium.
specification
Based on C25H27N908S2 (l)0.5g (2) 1.og (3)1.5g (4)2.Og (5) 3.og
storage
closed, cold preservation.
Last Update：2022-01-01 11:40:58
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Product Name: Cefoperazone sodium Request for quotation
CAS: 62893-20-3
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