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 |
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. |
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 |
(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.
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 °.
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.
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.
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).
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.
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.
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.
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.
take this product, according to the determination of moisture (General 0832 first method 1), the water content shall not exceed 5.0%.
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)
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)
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)
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)
measured by high performance liquid chromatography (General 0512).
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.
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.
B-lactam antibiotics, oxygen cephalosporins.
below 5°C, sealed storage.
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.
This product is white to light yellow powder or lumps; Odorless, with hygroscopicity.
take this product, according to the identification (2) or (3), (4), (6) test under the item of latamoxef sodium, show the same results.
The content under the item of loading amount difference was obtained by measuring according to the method of the item of sodium latamoxef.
Same as latamoxef sodium.
Based on C20H20N609S (1 )0.25g (2 )0.5g(3)1.0g
shade, seal, and store in a cool and dry place.