59798-30-0
Mezlocillin sodium
CAS: 59798-30-0
Molecular Formula: C22H27N6NaO9S2
59798-30-0 - Names and Identifiers
59798-30-0 - Physico-chemical Properties
| Molecular Formula | C22H27N6NaO9S2 |
| Molar Mass | 606.6 |
| Melting Point | 197-201°C (dec.) |
| Boling Point | 655.5°C at 760 mmHg |
| Specific Rotation(α) | ＋175°～＋195° |
| Water Solubility | Soluble in water or DMSO |
| Solubility | Soluble in water or methanol, slightly soluble in ethanol, slightly soluble in acetone, almost insoluble in isopropanol, ethyl acetate or ether. |
| Appearance | White or white-like powder or crystal |
| Color | White to Off-White |
| Storage Condition | Refrigerator |
| MDL | MFCD07793332 |
59798-30-0 - Standard
Authoritative Data Verified Data
(2S,5R,6R)-3, 3-dimethyl-6-[(2R)-[3-(methylsulfonyl)]-2-oxo-1-imidazolidinylcarboxamido]-2-phenylacetamido]-7-oxo-4-thia-1-azabicyclo [3. 2.0] heptane-2-carboxylic acid sodium salt. Mezlocillin (C21 H25N508S2) should be 91.0% ~ 97.8% based on the calculation of anhydrous.
Last Update：2024-01-02 23:10:35
59798-30-0 - Trait
Authoritative Data Verified Data
- This product is white or off-white powder or crystal; Odorless or slightly with specific odor; With hygroscopicity.
- This product is soluble in water or methanol, slightly soluble in ethanol, very slightly soluble in acetone, almost insoluble in isopropanol, ethyl acetate or ether.
specific rotation
take this product, precision weighing, adding water to dissolve and quantitatively dilute to make a solution containing about 10 mg per lml, and determine according to law (General rule 0621). The specific rotation is 175 ° to 195 °.
Last Update：2022-01-01 14:19:06
59798-30-0 - Differential diagnosis
Authoritative Data Verified Data
- take the product and Mezlocillin reference, respectively, dissolved in water and diluted into 4mg per 1 mL solution, according to thin layer chromatography (General 0502) test, 5 u1 of each of the above two solutions were absorbed within 10 minutes, respectively, on the same silica gel G thin layer plate, with methanol-chloroform-water-pyridine (90:80:30:10) as the developing solvent, after deployment, take out, dry, set iodine vapor in the color, the test solution shows the main spot position and color should be the same as the reference solution main spot position and color.
- 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 627).
- This product shows the reaction of sodium salt identification (1) (General rule 0301).
- two items (1) and (2) above can be selected as one item.
Last Update：2022-01-01 14:19:07
59798-30-0 - Exam
Authoritative Data Verified Data
pH
take this product, add water to make a solution containing O.lg per lml, and determine it according to law (General 0631). The pH value should be 4.5~7.5.
clarity and color of solution
take 5 parts of this product, each G, respectively, after adding water 5ml dissolved, the solution should be clear and colorless; If it is turbid, compare it with No. 1 turbidity standard solution (General rule 0902 first method), shall not be more concentrated; If the color is developed, it shall not be deeper in comparison with the yellow No. 2 Standard Colorimetric solution (General Principles 0901 first method).
Related substances
take an appropriate amount of this product, add water to dissolve and dilute to make a solution containing about 0.6mg per lml as a test solution; Take 1ml for precision measurement and put it in a 100ml measuring flask, dilute with water to the scale, shake, as a control solution, according to the chromatographic conditions under the content determination item, take the sample solution and the control solution of 20 u1, human liquid chromatograph was injected respectively, and the chromatogram was recorded to 1.5 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 1.5 times (1.5%) of the area of the main peak of the control solution, the sum of each impurity peak area shall not be greater than 4 times (4.0%) of the main peak area of the control solution.
Mezlocillin polymer
measured by size exclusion chromatography (General 0514).
chromatographic conditions and system suitability test
with dextran gel G-10(40 ~ 120um) as the filler, the inner diameter of the glass column is 1.0~1.4, the length of the column is 30 ~ 40cm, mobile phase A was 8.0 mol/L phosphate buffer (pH 0.05) [0.05mol/L disodium hydrogen phosphate solution -0.05mol/L sodium dihydrogen phosphate solution (95:5)]; Mobile phase B was water, the flow rate was 1.5ml per minute, and the detection wavelength was 254nm. Take 0.2~2000 u1 of 100 mg/ml Blue dextran 200 solution and inject it into human liquid chromatograph, measure with mobile phase A and B respectively, and record chromatogram. The number of theoretical plates is not less than 2000 calculated by the Blue dextran 400 peak, 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 and the polymer peak in the test solution to the Blue dextran 2000 peak in the corresponding chromatography system should be between 0.93 and 1.07. 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 5 when the control solution is 100 ~ 200ul for 5 consecutive injections. Preparation of control solution about 20mg of Mezlocillin control was precisely weighed, dissolved with water and quantitatively diluted to make a solution containing about 0.2mg per 1 ml.
assay
take 0.2g of this product, accurately weigh it, put it in a 10ml measuring flask, add water to dissolve and dilute to the scale, shake well, immediately take 100~200u1 and inject it into the liquid chromatograph, the mobile phase A was used as the mobile phase, and the chromatogram was recorded. In addition, 100~200u1 of the control solution was injected into the human liquid chromatograph, and the mobile phase B was used as the mobile phase for the same measurement, and the chromatogram was recorded. Mezlocillin-containing polymers shall not exceed 0.3% as calculated by the peak area of Mezlocillin as external standard method.
residual solvent
take 0.3g of this product, precision weighing, top empty bottle, precision add water 3ml to dissolve, seal, as a test solution; Respectively, precision weighing methanol, ethanol, acetone, isopropyl alcohol, ethyl acetate, pyridine and toluene are Diluted quantitatively with water to make methanol 300ug, ethanol 500ug, acetone 500ug, isopropyl alcohol 500ug, ethyl acetate 500ug, pyridine 20ug, 89ug of toluene solution, take 3ml of precision, top empty bottle, sealed, as a reference solution. Test as residual solvent assay (General 0861 second method). The capillary column with 100% dimethylpolysiloxane (or similar polarity) as the stationary liquid was used as the chromatographic column; The inlet temperature was 150°C; The detector temperature was 250°C; The initial temperature was 40°C, and maintained for 6 minutes, then the temperature was increased to 150°C at a rate of 20°C per minute for 8 minutes; The headspace sample was injected, and the equilibrium temperature of the headspace bottle was 80°C, and the equilibrium time was 30 minutes, take the reference solution into the headspace, according to the order of methanol, ethanol, acetone, isopropanol, ethyl acetate, pyridine, toluene peaks, the separation between the peaks should meet the requirements. Then take the sample solution and the reference solution into the headspace respectively, record the chromatogram, according to the external standard method to calculate the peak area, methanol, ethanol, acetone, isopropanol, ethyl acetate, the residues of pyridine and toluene shall be in accordance with the regulations.
moisture
take this product, according to the moisture determination method (General 0832 first method 1), the water content shall not exceed 6.0%.
visible foreign body
take 5 parts of this product, each 4g, 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 20mg per lml, and check according to law (General rule 0903), in each lg sample, no more than 6000 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), the amount of endotoxin per 1 mg Mezlocillin should be less than 0.060EU. (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 14:19:08
59798-30-0 - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with eighteen alkyl silane was used as filler; Phosphate buffer solution (4.9g of potassium dihydrogen phosphate and 0.45g of Dipotassium hydrogen phosphate, dissolved in water and diluted to ML)-acetonitrile (80:20) was used as mobile phase; the detection wavelength was 210mn. Take an appropriate amount of this product, add water to dissolve and dilute the solution containing 0.6mg per lml, water bath heating for 5~8 minutes, take 20u1 injection human liquid chromatograph, the separation degree between Mezlocillin peak and its impurity peak at relative retention time 0.93 should meet the requirements.
assay
take an appropriate amount of this product, accurately weigh, add water to dissolve and quantitatively dilute to make a solution containing about 0.15mg per lml, as a test solution, take 20u1 injection of human liquid chromatograph for precision measurement, the chromatogram was recorded, and Mezlocillin reference substance was used in the same method. The content of C21H25N5O8S2 in the test sample was calculated by the peak area according to the external standard method.
Last Update：2022-01-01 14:19:09
59798-30-0 - Category
Authoritative Data Verified Data
antibiotics.
Last Update：2022-01-01 14:19:09
59798-30-0 - Storage
Authoritative Data Verified Data
sealed and stored in a cool dark dry place.
Last Update：2022-01-01 14:19:09
59798-30-0 - Mezlocillin sodium for injection
Authoritative Data Verified Data
This product is sterile powder or sterile lyophilized product of Mezlocillin sodium. The content of Mezlocillin (C21H25N508S2) shall not be less than 91.0% calculated as anhydrous; The content of Mezlocillin (C21H25N508S2) shall be 90.0% ~ 110.0% of the label amount calculated as the average loading.
trait
This product is white or off-white powder or crystalline or loose lumps.
identification
take this product, according to Mezlocillin sodium under the identification of (1), (2), (4) test, showed the same results. The above (1), (2) two items can be done one.
examination
- 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 than the yellow No. 3 Standard Colorimetric solution (General rule 0901 first method).
- insoluble particles this product is taken, and the labeled amount is added to the particle inspection water to make a solution containing 20mg per 1 ml, which is inspected according to law (General rule 0903), and the labeled amount is 1. The conversion below Og is per l. No more than 6000 particles with 10um and lOum in Og sample, no more than 600 particles with 25um and 25um; The labeled amount is more than l.0g (including l.0g). No more than 6000 particles of 10um or more and no more than 600 particles of 25um or more should be contained in each sample container.
- the pH value, related substances, Mezlocillin polymer, moisture, bacterial endotoxin and sterility shall be checked according to the method of Mezlocillin sodium.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
The contents under the item of loading amount difference were obtained by measuring according to the method of Mezlocillin sodium.
category
with Mezlocillin sodium.
specification
Based on C21H25N508S2 (1)0.5g (2)1.0g(3)1.5g (4)2.Og (5)2.5g (6)3.Og (7)3.5g (8) 4.og
storage
sealed and stored in a cool dark dry place.
Last Update：2022-01-01 14:19:10
Supplier List
Multiple Specifications
Product Name: Mezlocillin sodium Visit Supplier Webpage Request for quotationCAS: 59798-30-0
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
Multiple Specifications
Product Name: Mezlocillin sodium Visit Supplier Webpage Request for quotationCAS: 59798-30-0
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
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