mixture of isomers
moxalactam sodium salt
CAS: 64953-12-4
Molecular Formula: C20H21N6NaO9S
mixture of isomers - Names and Identifiers
| Name | moxalactam sodium salt |
| Synonyms | 6059s ly127935 latamoxefsodium antibiotic6059-s Latamoxef sodium disodiumlatamoxef moxalactam sodium moxalactamdisodium mixture of isomers Moxalactam Disodium moxalactam sodium salt MOXALACTAM SODIUM SALT 5-oxa-1-azabicyclo(4.2.o)oct-2-ene-2-carboxylicacid,7-((carboxy(4-hydroxyphen disodium 7-{[carboxylato(4-hydroxyphenyl)acetyl]amino}-7-methoxy-3-{[(1-methyl-1H-tetrazol-5-yl)sulfanyl]methyl}-8-oxo-5-oxa-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate disodium (6R,7R)-7-{[carboxylato(4-hydroxyphenyl)acetyl]amino}-7-methoxy-3-{[(1-methyl-1H-tetrazol-5-yl)sulfanyl]methyl}-8-oxo-5-oxa-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate |
| CAS | 64953-12-4 |
| EINECS | 265-288-4 |
| InChI | InChI=1/C20H20N6O9S.2Na/c1-25-19(22-23-24-25)36-8-10-7-35-18-20(34-2,17(33)26(18)13(10)16(31)32)21-14(28)12(15(29)30)9-3-5-11(27)6-4-9;;/h3-6,12,18,27H,7-8H2,1-2H3,(H,21,28)(H,29,30)(H,31,32);;/q;2*+1/p-2/t12?,18-,20+;;/m1../s1 |
| InChIKey | GRIXGZQULWMCLU-GDUWRUPCSA-L |
mixture of isomers - Physico-chemical Properties
| Molecular Formula | C20H21N6NaO9S |
| Molar Mass | 544.47 |
| Melting Point | >156oC (dec.) |
| Specific Rotation(α) | D22 -45° (water) |
| Solubility | Methanol (Slightly) |
| Appearance | White to Pale Yellow |
| Merck | 13,6311 |
| Storage Condition | Inert atmosphere,2-8°C |
| Stability | Unstable in solution (DMSO or Methanol) |
| Use | This product is for scientific research only and shall not be used for other purposes. |
mixture of isomers - 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. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) |
| WGK Germany | 2 |
| RTECS | RN6824000 |
mixture of isomers - Standard
Authoritative Data Verified Data
(6R,7R)-7-[2-carboxy 2-(4-hydroxyphenyl)] acetamido] -7-methoxy-3-[(l-methyltetrathiazole-5-yl) thiomethyl]-8-oxo-5-oxa-1-azabicyclo [4.2.0] oct-2-dilute-2-carboxylic acid disodium salt. The content of C20H20N609S shall not be less than 83.0% calculated as anhydrous.
Last Update：2024-01-02 23:10:35
mixture of isomers - Trait
Authoritative Data Verified Data
- This product is white to light yellow powder or block; Odorless, with hygroscopicity.
- This product is soluble in water and methanol; Slightly soluble in ethanol, almost insoluble in ether.
specific rotation
take this product, precision weighing, plus phosphate buffer solution (pH 7.0) dissolved and quantitative dilution of about 10 mg per 1 mL solution, according to the law (General 0621), the specific rotation is from one to 32 ° to one to 40 °.
absorption coefficient
take this product, precision weighing, add water to dissolve and quantitatively dilute to make a solution containing about 20ug per lml, according to UV-visible spectrophotometry (General 0401), the absorbance was measured at a wavelength of 270nm, and the absorption coefficient was 200 to 230.
Last Update：2022-01-01 13:34:45
mixture of isomers - Differential diagnosis
Authoritative Data Verified Data
- take about 20mg of this product, add 15ml of water to dissolve, add 2ml of hydrochloric acid sodium acetate solution and 2ml of sodium hydroxide solution, place it for 5 minutes, add 3ml of lmol/L hydrochloric acid solution and 1ml of ferric chloride solution, after shaking, the solution was Tan.
- an appropriate amount of this product and the reference product of latroxobin were dissolved by adding water respectively to prepare a solution containing lOmg of latroxobin per 1 ml, which was used as the test solution and the reference solution. According to the thin layer chromatography (General 0502) test, absorb the above two solutions of 10 u1, respectively, on the same silica gel G thin layer plate, with ethyl acetate-water-acetonitrile-glacial acetic acid (21:9:7:7) for developing solvent, expand, take out, blow dry, set iodine vapor color. The position and color of the main spot displayed by the test solution should be the same as the position and color of the main spot of the reference solution.
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
- take an appropriate amount of this product, add water to dissolve and dilute it to make a solution containing about 20ug of latoxocephrin per lml, and measure it by UV-Vis spectrophotometry (General rule 0401), there should be maximum absorption at wavelengths of 226NM and 270Nm.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 1161).
- (6) This product shows the reaction of sodium salt identification (1) (General rule 0301).
- two items (2) and (3) above can be selected as one item.
Last Update：2022-01-01 13:34:46
mixture of isomers - Exam
Authoritative Data Verified Data
acidity
take this product and add water to make a solution containing about 0.lg of latamoxef per lml, and determine it according to law (General rule 0631). The pH value should be 5.0~7.0.
clarity and color of solution
take 5 parts of this product, respectively, add water to make each lml containing la Oxy cefo. 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).
isomer
In the chromatogram recorded under the content determination item, the ratio of the peak area of the latamoxef K isomer to the peak area of the latamoxef R isomer should be 0.8 to 1.4.
Related substances
take an appropriate amount of this product, add water to dissolve and dilute it regularly to make about each lml containing l. 0 mg of the solution was used as a test solution; 1 ml was accurately measured, placed in a 100ml measuring flask, diluted with water to a scale, and shaken to obtain a control solution. According to high performance liquid chromatography (General 0512) determination, with eighteen alkyl silane bonded silica gel as filler; Mobile phase A is O.Olmol/L ammonium acetate solution-methanol (99:1 ), mobile phase B is O.Olmol/L ammonium acetate solution-methanol (70:30), linear gradient elution was carried out according to the following table; The detection wavelength was 254nm. Take appropriate amount of test solution, heat in 80°C water bath for 30 minutes, cool, take 10u1 injection human liquid chromatograph, record chromatogram, the separation degree between the two main peaks of S isomer should be greater than 3.0, and the separation degree between the two main peaks and the adjacent impurity peaks should meet the requirements. l0ul of the test solution and the control solution were injected into the liquid chromatograph respectively, and the chromatograms were 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 2 times (2.0%) of the sum of the areas of the two main peaks of the control solution, the sum of each impurity peak area shall not be greater than 5 times (5.0%) of the sum of the two main peak areas of the control solution, and the peaks smaller than the two main peak areas and 0.05 times in the chromatogram of the test solution shall be ignored.
residual solvent
ethyl acetate, methyl ethyl ketone, acetone, methylene chloride and methanol take about 0.2g of this product, precision weigh it, place it in the top empty bottle, Precision Add internal standard solution (take the right amount of N-propanol, dilute with water to make a solution containing about 200ug per 1 ml) 5ml to dissolve, seal, as a test solution; Accurately weigh the appropriate amount of ethyl acetate, methyl ethyl ketone, acetone, methanol, dilute the flask to the scale with internal standard solution, shake well, and accurately weigh methylene chloride to about O.lg, put it in a 50m l measuring flask, Add 10ml of dimethyl sulfoxide to dissolve, dilute it to the scale with internal standard solution, shake well, and then accurately measure the appropriate amount of each of the above solutions, A solution (1) containing 200ug of ethyl acetate, 200ug of butanone, 200ug of acetone and 24ug of dichloromethane per 1 ml and a solution (2) containing 120ug of methanol per 1 ml were prepared by quantitative dilution with an internal standard solution. 5ml of each of the solution (1) and the solution (2) were accurately measured, respectively placed in two headspace bottles, sealed, and used as the control solution (1) and the control solution (2). Weigh the appropriate amount of nitromethane, methyl ethyl ketone and ethyl acetate, add the appropriate amount of dimethyl sulfoxide to dissolve, and dilute with internal standard solution to prepare a mixed solution containing about 200ug of nitromethane, 200ug of methyl ethyl ketone and 200ug of ethyl acetate per 1 ml, children take 5ml, in the top empty bottle, sealed, as the system applicable solution. According to the determination method of residual solvent (General Principle 0861 second method), the capillary column with 6% cyanopropyl phenyl-94% dimethyl polysiloxane (or similar polar) as stationary liquid is used as the column, and the initial temperature is 30°C, maintained for 15 minutes; Ran rose to 120°C at a rate of 8°C per minute, maintained for 8 minutes; The inlet temperature was 150°C, the detector temperature was 170°C; the Headspace bottle equilibration temperature was 80°C (ethyl acetate, butanone, acetone) or 60°C (methanol) and the equilibration time was 30 minutes. The applicable solution of the system is sampled by Headspace injection, and the peaks are sequentially extracted according to N-propanol, nitromethane, methyl ethyl ketone and ethyl acetate, and the separation degree between peaks shall meet the requirements. Take the sample solution, the reference solution (1) and the reference solution (2) into the headspace respectively, record the chromatogram, according to the internal standard method to calculate the peak area ratio, ethyl acetate, methyl ethyl ketone, acetone, dichloromethane and methanol residues shall be in accordance with the provisions.
pyridine and nitromethane
take this product about 0.5g, precision weighing, top empty bottle, precision plus internal standard solution (take the right amount of N-propanol, diluted with water to make a solution containing about 200ug per 1 ml) 5ml to dissolve, sealed, as a test solution; Precision weighing pyridine, nitromethane each about 0.2g, respectively, put 100ml of Dong bottle, add dimethyl sulfoxide 10ml to dissolve, dilute to the scale with internal standard solution, shake well, take an appropriate amount with precision, and dilute quantitatively with internal standard solution to make a stewed solution containing 20ug nitromethane 5 of pyridine per 1 ml. Precision children take 5ml, top empty bottle, sealed, as a reference solution. Under the chromatographic conditions of ethyl acetate, methyl ethyl ketone, acetone, methylene chloride and methanol, the equilibrium temperature of the headspace bottle was 80 ° C. And the equilibrium time was 30 minutes. The test solution and the reference solution are injected in Headspace respectively, the chromatogram is recorded, and the ratio of peak area is calculated according to the internal standard method. The residual amount of pyridine and nitromethane 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%.
visible foreign body
take 5 parts of this product, each part is the maximum specification of the preparation, and the particle inspection water is dissolved, and the inspection is carried out according to law (General rule 0904 ), and the requirements shall be met. (For aseptic dispensing)
insoluble particles
Take 3 parts of this product, and make a solution containing 50mg per lml of water for particle inspection, and check it according to law (General rule 0903). In each lg sample, no more than 6000 particles containing lOum or more, and no more than 600 particles containing 25um or more. (For aseptic dispensing)
bacterial endotoxin
take this product, check according to the law (General rule 1143), the amount of endotoxin in each lmg of la-oxy cephalosporin should be less than 0.050ELL (for injection)
sterile
take this product, dissolve and dilute with 0.1% sterile peptone aqueous solution, treat it by membrane filtration method, and check it according to law (General rule 1101). (For aseptic dispensing)
Last Update：2022-01-01 13:34:47
mixture of isomers - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with decylsilane was used as a filler; 0.01 mol/L ammonium acetate solution-methanol (19:1) was used as a mobile phase; And the detection wavelength was 254mn. Take an appropriate amount of the reference product of lacholine, add water to dissolve and dilute to a solution containing about 0.25mg per 1 ml, take the above solution, heat it in a water bath at 80°C for 30 minutes, and cool it, 10u1 was injected into the human liquid chromatograph, and the chromatogram was recorded. The isomer of latanocephalosporin and the isomer of latanocephalosporin S were eluted sequentially; the resolution between the R isomer peak of latxocephalosporin and the S isomer peak of latxocephalosporin should be greater than 4.0, and the resolution between the two main peaks and the adjacent impurity peaks should meet the requirements.
assay
take an appropriate amount of this product (about 25mg of latamoxef), accurately weigh it, put it in a 100ml measuring flask, add water to dissolve and dilute to the scale, shake well as a test solution; take 10u1 injection liquid chromatograph, record the chromatogram; Take the appropriate amount of the reference product of the La Oxy cephalosporin, and determine by the same method. Calculate the content of C20H20N609S in the test sample by the peak area according to the external standard method.
Last Update：2022-01-01 13:34:48
mixture of isomers - Category
Authoritative Data Verified Data
B-lactam antibiotics, oxygen cephalosporins.
Last Update：2022-01-01 13:34:48
mixture of isomers - Storage
Authoritative Data Verified Data
below 5°C, sealed storage.
Last Update：2022-01-01 13:34:49
mixture of isomers - Latamoxef Sodium for Injection
Authoritative Data Verified Data
This product is sterile powder or sterile lyophilized product of latamoxef sodium. Based on the average loading, the amount of the labido-containing cephalosporin (C20H20N609S) shall be 90.0% to 110.0% of the labeled amount.
trait
This product is white to light yellow powder or lumps; Odorless, with hygroscopicity.
identification
take this product, according to the identification (2) or (3), (4), (6) test under the item of latamoxef sodium, show the same results.
examination
- the clarity and color of the solution are 5 parts of this product, and the water is added according to the labeled amount to make about 0 per 1 ml. 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 No. 7 (general rule 0901, Method 1).
- appropriate amount of related substances shall be taken and determined according to the method for sodium latamoxef. The area of single impurity peak shall not be greater than 4 times (4.0%) of the area of the two main peaks of the control solution, the sum of each impurity peak area shall not be greater than 7 times (7.0%) of the sum of the two main peak areas of the control solution.
- the moisture content of this product shall not exceed 0832 (sterile powder) or 5.0% (sterile lyophilized product) as determined by the moisture determination method (General rule 2.0%, first method 1).
- insoluble particles this product is taken, and the solution containing 50mg per 1 ml of water is prepared by adding particles according to the labeled amount and checking according to law (General rule 0903 ), A labeled amount of 1.0g or less is converted per l. No more than 6000 particles of 10um and lOum in the Og sample, no more than 600 particles of 25um and 25um; The labeled amount is l.Og or more (including l.Og) no more than 6000 particles with loum and more than lOum and no more than 600 particles with 25um and more than 25um in each sample container.
- the acidity, isomer, bacterial endotoxin and sterility shall be checked according to the method under the item of sodium latamoxef.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
The content under the item of loading amount difference was obtained by measuring according to the method of the item of sodium latamoxef.
category
Same as latamoxef sodium.
specification
Based on C20H20N609S (1 )0.25g (2 )0.5g(3)1.0g
storage
shade, seal, and store in a cool and dry place.
Last Update：2022-01-01 13:34:49
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