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3-dimethyl-7-oxo-henyl)-5-methyl-4-isoxazolyl)carbonyl)amino)-monosodiums

flucloxacillin sodium

CAS: 1847-24-1

Molecular Formula: C19H16ClFN3NaO5S

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3-dimethyl-7-oxo-henyl)-5-methyl-4-isoxazolyl)carbonyl)amino)-monosodiums - Names and Identifiers

Name flucloxacillin sodium
Synonyms MFI-PC
NSC 277175
floxapensodium
Floxapen sodium
floxacillinsodium
Floxacillin sodium
Floxacillin Na salt
Stafopen sodium salt
Sodium flucloxacillin
Staphylex Sodium salt
flucloxacillin sodium
Monosodium flucloxacillin
Flucloxacillin sodium salt
Flucloxacillin sodium BP98
(2s-(2-alpha,5-alpha,6-beta))-al
5-methyl-3-(2-chloro-6-fluorophenyl)-4-isoxazolylpenicillinsodium
5-Methyl-3-(2-chloro-6-fluorophenyl)-4-isoxazolylpenicillin sodium
3-dimethyl-7-oxo-henyl)-5-methyl-4-isoxazolyl)carbonyl)amino)-monosodiums
4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylicacid,6-(((3-(2-chloro-6-fluorop
sodium 6-({[3-(2-chloro-6-fluorophenyl)-5-methylisoxazol-4-yl]carbonyl}amino)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate
6-({[3-(2-chloro-6-fluorophenyl)-5-methyl-1,2-oxazol-4-yl]carbonyl}amino)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid
(2S,5R,6R)-6-({[3-(2-chloro-6-fluorophenyl)-5-methyl-1,2-oxazol-4-yl]carbonyl}amino)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid
sodium (2S,5R,6R)-6-({[3-(2-chloro-6-fluorophenyl)-5-methyl-1,2-oxazol-4-yl]carbonyl}amino)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate
sodium [2S-(2alpha,5alpha,6beta)]-6-[[[3-(2-chloro-6-fluorophenyl)-5-methylisoxazol-4-yl]carbonyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate
Sodium (2S-(2alpha,5alpha,6beta))-6-(((3-(2-chloro-6-fluorophenyl)-5-methylisoxazol-4-yl)carbonyl)amino)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylate
4-Thia-1-azabicyclo(3.2.0)heptane-2-carboxylic acid, 6-(((3-(2-chloro-6-fluorophenyl)-5-methyl-4-isoxazolyl)carbonyl)amino)-3,3-dimethyl-7-oxo-, monosodium salt, (2S,5R,6R)-
4-Thia-1-azabicyclo(3.2.0)heptane-2-carboxylic acid, 6-(((3-(2-chloro-6-fluorophenyl)-5-methyl-4-isoxazolyl)carbonyl)amino)-3,3-dimethyl-7-oxo-, monosodium salt, (2S-(2-alpha,5-alpha,6-beta))-
CAS 1847-24-1
EINECS 217-428-0
InChI InChI=1/C19H17ClFN3O5S.Na/c1-7-10(12(23-29-7)11-8(20)5-4-6-9(11)21)15(25)22-13-16(26)24-14(18(27)28)19(2,3)30-17(13)24;/h4-6,13-14,17H,1-3H3,(H,22,25)(H,27,28);/q;+1/p-1
InChIKey OTEANHMVDHZOPB-SLINCCQESA-M

3-dimethyl-7-oxo-henyl)-5-methyl-4-isoxazolyl)carbonyl)amino)-monosodiums - Physico-chemical Properties

Molecular FormulaC19H16ClFN3NaO5S
Molar Mass475.85
Melting Point176-178°C
Boling Point677℃
Flash Point>110°(230°F)
Water SolubilitySoluble in water
Solubility H2O: soluble20mg/mL, clear
Vapor Presure2.86E-19mmHg at 25°C
AppearanceWhite powder
Colorwhite to beige
Storage Condition2-8°C
SensitiveLight Sensitive
Physical and Chemical PropertiesWhite or almost white crystalline powder, soluble in water (1:1), soluble in ethanol (1:12) or acetone (1:12).
UseThis product is for scientific research only and shall not be used for other purposes.
In vivo study The serum elimination half-life of flucloxacillin is 1.31-1.39 hours, and six hours after administration of a single 250 mg dose the serum concentration of flucloxacillin is 0.46 micrograms/mL. Oral flucloxacillin does not affect sweat electrolytes and is not a contraindication to sweat testing. Flucloxacillin has been reported to be metabolized in man to the penicilloic acid, the antibacterially active 5'-hydroxymethyl derivative and the penicilloic acid of the 5'-hydroxymethyl derivative. The metabolism of flucloxacillin in the rat is similar.

3-dimethyl-7-oxo-henyl)-5-methyl-4-isoxazolyl)carbonyl)amino)-monosodiums - Risk and Safety

WGK Germany3
RTECSXH8680000
ToxicityLD50 oral in rabbit: > 8gm/kg

3-dimethyl-7-oxo-henyl)-5-methyl-4-isoxazolyl)carbonyl)amino)-monosodiums - Standard

Authoritative Data Verified Data

(2S ,5R,6R)-6-[[[3-(2-chloro-6-chlorophenyl)]-5-methylisoxazol-4-yl] carbonyl] amino] -3, 3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-sodium formate monohydrate. Cloxacillin fluoride (C19H17C1FN3O5S) shall not be less than 91.0% calculated as anhydrous.

Last Update：2024-01-02 23:10:35

3-dimethyl-7-oxo-henyl)-5-methyl-4-isoxazolyl)carbonyl)amino)-monosodiums - Trait

Authoritative Data Verified Data
  • This product is white or off-white crystalline powder; There is hygroscopicity.
  • This product is very soluble in water, soluble in methanol, soluble in ethanol.

specific rotation

take an appropriate amount of this product, accurately weigh it, add water to dissolve and quantitatively dilute it to make a solution containing about 10 mg per lml, and determine it according to law (General rule 0621), the specific rotation was 158 ° to 168 °.

Last Update：2022-01-01 13:41:12

3-dimethyl-7-oxo-henyl)-5-methyl-4-isoxazolyl)carbonyl)amino)-monosodiums - Differential diagnosis

Authoritative Data Verified Data
  1. take about 2mg of this product, add 0.05ml of water and 2ml of sulfuric acid-formaldehyde test solution (take 2ml of formaldehyde solution, add 100ml of sulfuric acid, mix well), mix well, the solution appears yellow-green, after heating in a water bath for 1 min, the solution turned yellow.
  2. 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.
  3. The infrared absorption spectrum of this product should be consistent with that of the reference product (General rule 0402).
  4. This product shows the reaction of sodium salt identification (1) (General rule 0301).
Last Update：2022-01-01 13:41:13

3-dimethyl-7-oxo-henyl)-5-methyl-4-isoxazolyl)carbonyl)amino)-monosodiums - Exam

Authoritative Data Verified Data

crystallinity

take a small amount of this product, according to the law inspection (General 0981), should comply with the provisions.

acidity

take this product, add water to make about 0.lg of fluorine-containing cloxacillin solution per 1 ml, and determine it according to law (General rule 0631). The pH value should be 5.0~7.0.

clarity of the solution

take 5 parts of this product, each 0.6g, respectively, after adding water 5ml to dissolve, the solution should be clear; If it is turbid, compare with No. 1 turbidity standard solution (General rule 0902 second method), none should be more concentrated.

absorbance

take this product and add water to make about fluorine-containing cloxacillin O per lml. lg of the solution, measured by UV-Vis spectrophotometry (General rule 0401) at a wavelength of 430nm, the absorbance should not be greater than 0.04.

Related substances

take an appropriate amount of this product, accurately weigh it, add mobile phase to dissolve and dilute to prepare a solution containing about fluorine-containing cloxacillin lmg per lml, as a test solution; Take 1ml for precision measurement, in a 100ml measuring flask, dilute to the scale with mobile phase, shake well, and use as a control solution; Take an appropriate amount of the control solution precisely, and quantitatively dilute with the mobile phase to make about 0.5ug of fluorine-containing gas-penicillin per 1ml, as a sensitivity solution. According to the chromatographic condition test under the content determination item, the sensitivity solution 20u1 is injected into the liquid chromatograph, and the signal-to-noise ratio of the main component peak peak is greater than 10. 20 u1 of the test solution and the control solution were respectively injected into the liquid chromatograph, and the chromatogram was recorded to 6 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 the area of the main peak of the control solution (1.0%), the sum of each impurity peak area shall not be greater than 5 times (5.0%) of the main peak area of the control solution. The peaks in the chromatogram of the test solution which are smaller than the main peak area of the sensitivity solution are ignored.

residual solvent

acetone, ethyl acetate, ethanol and methanol take this product about 0.3g, precision weighing, top empty bottle, precision add water 3ml to dissolve, sealed, as a test solution; precision weighing appropriate amount of acetone, ethyl acetate, ethanol and methanol respectively, and quantitative dilution with water to make acetone 0.5mg, acetic acid 0.5mg, A mixed solution of 0.5mg of ethanol and 0.3mg of methanol was accurately weighed into 3ml, placed in a headspace bottle, sealed, and used as a reference solution. According to the test for determination of residual solvents (General rule 0861, second method), the capillary column with 100% dimethylpolysiloxane (or similar polarity) as stationary liquid is used as the chromatographic column, the initial temperature is 40°C, and the retention time is 6 minutes, then the temperature is increased to 120°C at a rate of 20°C per minute for 5 minutes; The inlet temperature is 200°C and the detector temperature is 250°C; The equilibrium temperature of the headspace bottle is 80°C, the equilibration time was 30 minutes. The reference solution is injected in the headspace, and the chromatogram is recorded. The peaks are obtained in the order of methanol, ethanol, acetone and ethyl acetate, and the separation degree between the peaks of each component shall meet the requirements. Then the test solution and the reference solution are injected by Headspace, and the chromatogram is recorded. The residual amount of acetone, ethyl acetate, ethanol and methanol shall be calculated by peak area according to external standard method.

N ,N-dimethylformamide

take this product about 0.3g, precision weighing, and dimethyl sulfoxide dissolved and quantitatively diluted into about 30mg solution per 1 ml, shake, as a test solution; an appropriate amount of N,N-dimethylformamide control was accurately weighed and quantitatively diluted with dimethyl sulfoxide to prepare a solution containing 26ug per 1 ml as a control solution. According to the test for determination of residual solvents (General Principle 0861 third method), the capillary column with 5% phenyl-95% dimethyl polysiloxane (or similar polarity) as stationary liquid is used as the column, and the column temperature is 10°C; the inlet temperature is 200°C; The detector temperature is 250°C, and the lul of the sample solution and the reference solution are accurately measured, and the human gas chromatograph is injected respectively, and the chromatogram is recorded, according to the external standard method to calculate the peak area, N,N-dimethylformamide residues should comply with the provisions.

2-ethylhexanoic acid

take this product, determination according to law (General Principles 0873), not over 0.8%.

moisture

take this product about 0.3g, according to the moisture determination method (General 0832 first method 1), the moisture content should be 3.0% ~ 4.5%.

Heavy metals

This product l.Og, inspection according to law (General Principles 0821 The first law), containing heavy metals shall not exceed 20 parts per million.

visible foreign body

take 5 parts of this product, each 1.0g, 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 about 50mg per 1 ml, and check according to law (General 0903), per l. In the Og sample, no more than 6000 particles with lOum and lOum, and no more than 600 particles with 25um and 25um. (For aseptic dispensing)

bacterial endotoxin

take this product, according to the detection (General 1143), the amount of endotoxin in flucloxacillin per 1 mg should be less than 0.35EU. (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 13:41:14

3-dimethyl-7-oxo-henyl)-5-methyl-4-isoxazolyl)carbonyl)amino)-monosodiums - 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 as filler; Acetonitrile -2.7g/ L potassium dihydrogen phosphate solution (adjusted to pH 5.0 with 1 mol/L sodium hydroxide solution)(25:75) as mobile phase, the detection wavelength was 225nm. Take about 5mg of each of the fluticillin control and cloxacillin control, put them in 50ml measuring flask, dissolve with mobile phase and dilute to the scale, shake well, take 20u1 and inject human liquid chromatograph, record chromatogram, the resolution between the peak of flucloxillin and the peak of chlorazoxillin should be greater than 2.5.

assay

Take appropriate amount of this product, precision weighing, add mobile phase to dissolve and dilute to make about fluorine-containing cloxacillin 0.lmg solution, shake, as a test solution, the precision of 20u1 injection into the liquid chromatograph, record the chromatogram; Take the right amount of flucloxacillin reference, the same method for determination, the content of c19h17c1fn305 s in the sample was calculated by the peak area according to the external standard method.

Last Update：2022-01-01 13:41:15

3-dimethyl-7-oxo-henyl)-5-methyl-4-isoxazolyl)carbonyl)amino)-monosodiums - Category

Authoritative Data Verified Data

B-lactam antibiotics, penicillins.

Last Update：2022-01-01 13:41:15

3-dimethyl-7-oxo-henyl)-5-methyl-4-isoxazolyl)carbonyl)amino)-monosodiums - Storage

Authoritative Data Verified Data

sealed and stored in a cool dark dry place.

Last Update：2022-01-01 13:41:15

3-dimethyl-7-oxo-henyl)-5-methyl-4-isoxazolyl)carbonyl)amino)-monosodiums - Flucloxacillin sodium capsules

Authoritative Data Verified Data

The fluorine-containing cloxacillin sodium of this product shall be calculated as flucloxacillin (C19H17C1FN305S), and shall be 92.5% ~ 107.5% of the labeled amount.

trait

The content of this product is white or white crystalline powder.

identification

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 control solution.

examination

  • appropriate amount of contents under the item of difference in loading amount of related substances, add mobile phase to dissolve and dilute Flucloxacillin sodium to prepare a solution containing about 1 mg of fluorine-containing aerocillin per 1 ml, filter, take the filtrate as the test solution, according to the method under the Flucloxacillin sodium determination, should comply with the provisions.
  • moisture the contents of this product shall not contain more than 0832 of moisture as determined by the method for determination of moisture (General rule 5.0%, first method).
  • the dissolution of this product, according to the dissolution and release determination method (General rule 0931 first method), with water as the dissolution medium, the speed is 100 rpm, according to the law, after 20 minutes, take the appropriate amount of solution, filter, take the appropriate amount of filtrate, dilute quantitatively with the dissolution medium to prepare the solution containing about 140ug of fluorine-containing cloxacillin per lml, according to UV-visible spectrophotometry (General rule 0401), determine the absorbance at the wavelength of 273nm; Take an appropriate amount of fluoracillin reference substance, the dissolution medium was added to dissolve and quantitatively dilute to prepare a solution containing about 140ug per 1 ml, which was determined by the same method, and the dissolution amount of each particle was calculated. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
  • others should comply with the relevant provisions under the capsule (General 0103).

Content determination

take the contents under the item of difference in loading amount, mix well, weigh accurately and take appropriate amount (about 0.25g equivalent to flucloxacillin), cloxacillin sodium was dissolved by adding mobile phase and diluted to make about fluorine-containing cloxacillin per 1 ml. 1 mg of the solution was filtered, and the filtrate was taken as a test solution, which was obtained by measuring according to the method under the item of Flucloxacillin sodium.

category

with Flucloxacillin sodium.

specification

0.258 (based on C19H17C1FN305S)

storage

sealed and stored in a cool dark dry place.

Last Update：2022-01-01 13:41:16

3-dimethyl-7-oxo-henyl)-5-methyl-4-isoxazolyl)carbonyl)amino)-monosodiums - Flucloxacillin sodium for injection

Authoritative Data Verified Data

This product is a sterile powder of Flucloxacillin sodium. The fluorine-containing cloxacillin (C19H17C1FN305S) shall not be less than 91.0% based on the water-free material; The fluorine-containing cloxacillin (C19H17C1FN305S) shall be 95.0% ~ 105.0% of the label amount based on the average loading.

trait

This product is white or off-white crystalline powder.

identification

The same results were obtained when tested according to the method under the identification of flucillin sodium.

examination

  • the clarity and color of the solution take 5 bottles of this product, and add water 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 No. 2 Standard Colorimetric solution (General rule 0901 method 1).
  • insoluble particles this product is taken, and the solution containing about 50mg per 1 ml of water is prepared by adding particles to the labeled amount and checking according to law (General rule 0903), no more than 6000 particles of 10um and 10um or more and no more than 600 particles of 25um and 25um or more per l. No more than 6000 particles with lOum and 10um or more and no more than 600 particles with 25um and 25um or more in each container of test article above Og (including l.0g).
  • the acidity, related substances, moisture, endotoxin and sterility of the seedlings shall be checked according to the method under the item of fluticillin 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 the item of Flucloxacillin sodium.

category

with Flucloxacillin sodium.

specification

calculated as C19H17C1FN305S (1)0.25g (2)0.5g(3)1.0g

storage

sealed and stored in a cool dark dry place.

Last Update：2022-01-01 13:41:17
3-dimethyl-7-oxo-henyl)-5-methyl-4-isoxazolyl)carbonyl)amino)-monosodiums
Supplier List
Hubei YoungXin Pharmaceutical Tech Co.,Ltd.
Spot supply
Product Name: Flucloxacillin Impurity 11 Visit Supplier Webpage Request for quotation
CAS: 1847-24-1
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Hefei TNJ Chemical Industry Co.,Ltd.
Product Name: flucloxacillin sodium Request for quotation
CAS: 1847-24-1
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Shanghai Yuanye Bio-Technology Co., Ltd.
Spot supply
Product Name: Flucloxacillin Sodium Visit Supplier Webpage Request for quotation
CAS: 1847-24-1
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409 Click to send a QQ message
Wechat: 18301782025
Hubei YoungXin Pharmaceutical Tech Co.,Ltd.
Spot supply
Product Name: Flucloxacillin Impurity 11 Visit Supplier Webpage Request for quotation
CAS: 1847-24-1
Tel: 0714-3999186
Email: 2853786052@qq.com
Mobile: 86+15671228036
QQ: 2853786052 Click to send a QQ message
Wechat: 15671228036
Hefei TNJ Chemical Industry Co.,Ltd.
Product Name: flucloxacillin sodium Request for quotation
CAS: 1847-24-1
Tel: 0086-551-65418684
Email: sales@tnjchem.com
　　　　 info@tnjchem.com
Mobile: 0086 189 4982 3763
QQ: 2881500840 Click to send a QQ message
Wechat: 0086 189 4982 3763
WhatsApp: 0086 189 4982 3763
Product List: View Catalog
Shanghai Yuanye Bio-Technology Co., Ltd.
Spot supply
Product Name: Flucloxacillin Sodium Visit Supplier Webpage Request for quotation
CAS: 1847-24-1
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409 Click to send a QQ message
Wechat: 18301782025
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3-dimethyl-7-oxo-henyl)-5-methyl-4-isoxazolyl)carbonyl)amino)-monosodiums
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