Prostaphlin sodium
Oxacillin sodium anhydrous
CAS: 1173-88-2;1773-88-2
Molecular Formula: C19H18N3NaO5S
Prostaphlin sodium - Names and Identifiers
Prostaphlin sodium - Physico-chemical Properties
| Molecular Formula | C19H18N3NaO5S |
| Molar Mass | 423.42 |
| Melting Point | 188°C |
| Boling Point | 686.8°C at 760 mmHg |
| Flash Point | 369.2°C |
| Solubility | H2O: soluble50mg/mL |
| Vapor Presure | 8.32E-20mmHg at 25°C |
| Appearance | crystalline |
| Color | colorless or white |
| BRN | 4098179 |
| Storage Condition | Inert atmosphere,2-8°C |
| Use | Bactericidal effect against penicillin-resistant Staphylococcus aureus |
Prostaphlin sodium - Risk and Safety
| Hazard Symbols | Xi - Irritant |
| Safety Description | S22 - Do not breathe dust. S24/25 - Avoid contact with skin and eyes. |
| WGK Germany | 2 |
| RTECS | XH9100000 |
Prostaphlin sodium - Upstream Downstream Industry
| Raw Materials | n-Butyl acetate Sulfuric acid Ethyl acetate |
Prostaphlin sodium - Standard
Authoritative Data Verified Data
(2S,5R,6R)-3, 3-dimethyl-6-(5-methyl-3-phenyl-4-isoxazolylamino)-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid sodium salt monohydrate. Oxacillin (C19H19N305S) shall not be less than 90.0%, calculated as anhydrous.
Last Update：2024-01-02 23:10:35
Prostaphlin sodium - Trait
Authoritative Data Verified Data
- This product is white powder or crystalline powder; Odorless or slightly odorless.
- This product is soluble in water, very slightly soluble in acetone or butanol, and almost insoluble in ethyl acetate or petroleum 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 195 ° to 214 °.
Last Update：2022-01-01 13:34:06
Prostaphlin sodium - Differential diagnosis
Authoritative Data Verified Data
- 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 239).
- This product shows the reaction of sodium salt identification (1) (General rule 0301).
Last Update：2022-01-01 13:34:06
Prostaphlin sodium - Exam
Authoritative Data Verified Data
acidity
take this product, add water to make a solution containing about 20mg per lml, according to the law (General 0631),pH value should be 5.0~7.0.
clarity and color of solution
take 5 parts of this product, each 0.6g, respectively, add water 5ml to dissolve, the solution should be clear and colorless (General rule 0901 first method); If it is turbid, compared with No. 1 turbidity standard solution (General Principles 0902 first method), shall not be more concentrated.
Related substances
take an appropriate amount of this product, precision weigh, add mobile phase to dissolve and dilute to make a solution containing about 1 mg of oxacillin per 1ml, as a test solution; Take 1ml for precision measurement, set in a 100ml measuring flask, dilute to the scale with the mobile phase, and shake to serve as a control solution. The appropriate amount of the control solution was accurately taken, and the solution containing about oxacillin lug per 1ml was prepared by quantitative dilution with the mobile phase as the sensitivity solution. According to the chromatographic conditions under the content determination item, take the sensitivity solution 20 u1, inject the human liquid chromatograph, record the chromatogram, and the signal-to-noise ratio of the main component peak height should be greater than 10. 20 u1 of the test solution and the control solution were respectively injected into the human liquid chromatograph, and the chromatogram was recorded to 7 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the sum of the peak areas of impurity B1 and impurity B2 shall not be greater than 1.5 times (1.5%) of the main peak area of the control solution; Impurity E) the peak area shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution; The peak area of cloxacillin shall not be greater than the main peak area of the control solution (1.0%); other single impurity peak area shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution; The sum of each impurity peak area shall not be greater than 3 times (3.0%) of the main peak area of the control solution.
oxacillin
polymers were determined by size exclusion chromatography (General 0514).
chromatographic conditions and system suitability test
dextran gel 010(40 to 1.0 um) was used as a filler, and the inner diameter of the glass column was 1.4cm to, and the column length was 30 to 40cm. Mobile phase A was 0 at pH 7.0. Olmol/L phosphate buffer [0.Olmol/L disodium hydrogen phosphate solution-O.Olmol/L sodium dihydrogen phosphate solution (61:39)], mobile phase B was water; The detection wavelength was 254nm. Take 2000~100 u1 of 200 Blue dextran solution (0. LMG/ml) and inject it into human liquid chromatograph (HPLC), and measure with mobile phase A and B respectively. The number of theoretical plates is not less than 2000 based on the Blue dextran 400 peak, the tailing factor should be less than 2.0. The ratio of the retention times 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 about 0.4g of oxacillin sodium, put it in a 10ml measuring flask, add 2000 mg/ml of Blue dextran solution to dissolve and dilute to the scale, shake well. Measure 100~200u1 and inject it into human liquid chromatograph, measure with mobile phase A, record chromatogram, and the peak height of high polymer and the valley height ratio between monomer and high polymer should be more than 2.0. The other mobile phase B as the mobile phase, the precision of the control solution 100~200 u1, continuous injection of 5 times, the relative standard deviation of peak area should not be greater than 5.0% .
preparation of control solution
a solution containing about 50ug per 1 ml was prepared by taking about 25mg of the reference substance of oxazole Bilin, precisely weighing it, dissolving it with water and quantitatively diluting it.
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, 100~200u1 is accurately weighed and injected into the human Liquid Chromatograph. The mobile phase A is used as the mobile phase for measurement, and the chromatogram is recorded. In addition, 100~200 u1 of the control solution was injected into the liquid chromatograph, and the mobile phase B was used as the mobile phase, and the same method was used for determination. The oxacillin peak area was calculated according to the external standard method, the amount of oxacillin-containing polymer should not exceed 0.10%.
residual solvent
take about lg of this product, put it in a 10ml Max bottle, add water to dissolve and dilute to the scale, shake well, use it as a stock solution for test, take lml and place it in the top empty bottle with precision, then add 1ml of water precisely, shake well, seal, and use as the test solution. Weigh 0.25g of ethanol, ethyl acetate, n-butanol and butyl acetate precisely, and place them in a 50ml measuring flask, dilute to the scale with water, shake, take 10ml accurately, put it in a 100ml measuring flask, dilute to the scale with water, shake well, as a reference stock solution; take the reference stock solution (lml) and place it in the top-empty bottle with precision, add water (1ml) with precision, shake well, seal, and use it as the system applicable solution; Take the reference stock solution (1ml) and place it in the top-empty bottle with precision, the sample stock solution (1ml) was added precisely, shaken, sealed, and used as a reference solution. According to the determination method of residual solvent (General 0861 second method), the capillary column with 100% dimethylpolysiloxane (or similar polarity) as the stationary liquid is used as the column; The initial temperature is 40°C, and the maintenance time is 8 minutes, then increase to 100°C at a rate of 30°C per minute for 5 minutes; The inlet temperature is 200°C; The detector temperature is 250°C; The equilibrium temperature of the headspace bottle is 70°C, the equilibrium time is 30 minutes; The system applicable solution is sampled at the head space, and the chromatogram is recorded. The order of peaks is ethanol, ethyl acetate, n-butanol and butyl acetate. The relative standard deviation shall not exceed 5.0% by taking the headspace injection of the reference solution and calculating the injection results for several times. The test solution and the reference solution were injected in the headspace respectively, the chromatogram was recorded, and the peak area was calculated by the standard addition method. Ethanol, ethyl acetate, n-butanol and butyl acetate residues shall be in accordance with the provisions.
2-ethylhexanoic acid
take this product, inspection according to law (General 0873), not over 0.8%.
moisture
take this product, according to the determination of moisture (General 0832-method 1), the water content shall not exceed 5.0%.
visible foreign body
take 5 parts of this product, each lg, 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 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 10um and more than lOum, 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 oxacillin should be less than 0.10EU. (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 13:34:08
Prostaphlin sodium - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
with eighteen alkyl silane bonded silica gel as filler, with potassium dihydrogen phosphate solution (take potassium dihydrogen phosphate 7G, add water 1000ml to dissolve, adjust pH value to 5.0 )-acetonitrile (75:25) as mobile phase; the detection wavelength was 225nm. Take 25mg of this product, put it in a 100ml measuring flask, add 1 ml of 0.05mol/L sodium hydroxide solution to dissolve it, place it for 3 minutes, dilute it with mobile phase to the scale, shake it well, prepare a mixed solution (1) containing about 0.25mg of oxacillin and its degradation impurities per 1 ml, and add an appropriate amount of cloxacillin reference substance, and add the mixed solution (1) dissolve and dilute to make cloxacillin in about 1 ml. lmg mixed solution (2), as the system applicable solution, take 20u1 injection liquid chromatograph, record chromatogram; Impurity B1, impurity B2, impurity D, the relative retention times of cloxacillin were 0.4,0.5,0.9 and 1.45, respectively. The resolution between impurity D peak and oxacillin peak should be greater than 1.5, the resolution between peak of oxacillin and peak of oxacillin should be more than 2.5.
assay
take the appropriate amount of this product, precision weighing, plus mobile phase dissolution and quantitative dilution made from each lml containing about oxacillin 0.lmg solution, as the test solution, the precision of 20ul injection liquid chromatograph, record the chromatogram; Take the oxacillin reference substance, the same method for determination. According to the external standard method, the content of cl9h19n305 s in the sample was calculated by the peak area.
Last Update：2022-01-01 13:34:08
Prostaphlin sodium - Category
Authoritative Data Verified Data
B-lactam antibiotics, penicillins.
Last Update：2022-01-01 13:34:08
Prostaphlin sodium - Storage
Authoritative Data Verified Data
sealed and stored in a dry place.
Last Update：2022-01-01 13:34:09
Prostaphlin sodium - Oxacillin sodium tablets
Authoritative Data Verified Data
This product contains oxacillin sodium by oxacillin (C19H19N305S) calculation, should be 90.0% ~ 110.0% of the label amount.
trait
This product is sugar-coated tablet or coated tablet, white or almost White after removing the coating.
identification
In the chromatogram recorded under the content determination, 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
- moisture the fine powder of this product shall be taken and determined according to the method for determination of moisture (General rule 0832, first method 1). The moisture content shall not exceed 6.0%.
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 second method), with water as the dissolution medium, the speed is 100 rpm, according to the law, after 45 minutes, take the appropriate amount of the solution, filter, take the appropriate amount of the filtrate, and dilute it quantitatively with water to make a solution containing about oxacillin 13 @ per 1 ml, measure absorbance at the wavelength of 225nm according to UV-Vis spectrophotometry (General rule 0401); Take appropriate amount of oxacillin reference substance by precise weighing, water was added to dissolve and quantitatively diluted to prepare a solution containing about 13ug per 1 ml, which was determined by the same method. Calculate the dissolution of each tablet, the limit is 75% of the label amount, should be consistent with the provisions.
- Take 10 tablets of this product, remove the coating, grind them finely, weigh an appropriate amount accurately, dissolve them with mobile phase and dilute them to make a solution containing about 1 mg of oxacillin per 1 ml, filter it, the filtrate was taken as the test solution, and determined according to the method under the item of oxacillin sodium. If there are impurity peaks in the chromatogram of the test solution, the sum of the peak areas of impurity B1 and impurity B2 shall not be greater than 1.5 times (1.5%) of the main peak area of the control solution; impurity D Peak area shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution; Cloxacillin peak area shall not be greater than the main peak area of the control solution (1.0%); other single impurity peak area shall not be greater than 0.8 times (0.8%) of the main peak area of the control solution; The sum of each impurity peak area shall not be greater than 3 times (3.0%) of the main peak area of the control solution.
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
Take 10 tablets of this product, remove the coating, grind it finely, weigh it accurately, take an appropriate amount (about 0.25g equivalent to oxacillin), and put it in a 250ml measuring flask, add the mobile phase to dissolve and dilute to the scale, shake, filter, take the filtrate 5ml accurately, put it in a 50ml measuring flask, dilute to the scale with the mobile phase, shake well, as a test solution, according to the method for determination of oxacillin sodium, that is obtained.
category
with oxacillin sodium.
specification
0.25g (based on C19H19N305S)
storage
sealed and stored in a dry place.
Last Update：2022-01-01 13:34:09
Prostaphlin sodium - Oxacillin sodium capsules
Authoritative Data Verified Data
This product contains oxacillin sodium by oxacillin (C19H19N305S) calculation, should be 90.0% ~ 110.0% of the label amount.
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
- moisture the contents of this product shall not contain more than 0832 of moisture as determined by the method for moisture determination (General rule 6.0%, Method 1).
- 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 45 minutes, take the appropriate amount of solution, filter, take the appropriate amount of filtrate, and dilute it quantitatively with water to make a solution containing about 13ug oxacillin per 1 ml, measure absorbance at the wavelength of 225nm according to UV-Vis spectrophotometry (General rule 0401); Take appropriate amount of oxacillin reference substance by precise weighing, water was added to dissolve and quantitatively diluted to prepare a solution containing about 13ug per 1 ml, which was determined by the same method. Calculate the amount of dissolution of each grain, the limit is 80% of the label amount, should be consistent with the provisions.
- appropriate amount of related substances shall be accurately weighed, dissolved and quantitatively diluted with mobile phase to make a solution containing about 1 mg of oxacillin per 1 ml, and filtered, take the continued filtrate as the test solution; According to the method of oxacillin sodium, if there is impurity peak, impurity B in the chromatogram of the test solution, the sum of the peak area with impurity B2 shall not be greater than 1.5 times (1.5%) of the main peak area of the control solution; The peak area of impurity D shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution; the Peak area of chlorazol two forests shall not be greater than the main peak area of the control solution (1.0%); The peak area of other individual impurities shall not be greater than 0.8 times (0.8%) of the main peak area of the control solution; the sum of each impurity peak area shall not be greater than 3 times (3.0%) of the main peak area of the control solution.
- others should comply with the relevant provisions under the capsule (General 0103).
Content determination
take the contents under the difference of loading amount, mix evenly, weigh an appropriate amount (about 0.25g equivalent to oxacillin) accurately, and put it in a 250ml measuring flask, add the mobile phase to dissolve and dilute to the scale, shake, filter, take the filtrate 5ml accurately, put it in a 50ml measuring flask, dilute to the scale with the mobile phase, shake well, as a test solution, according to the method for determination of oxacillin sodium, that is obtained.
category
with oxacillin sodium.
rule
0.25g (based on C19H19N305S)
storage
sealed and stored in a dry place.
Last Update：2022-01-01 13:34:10
Prostaphlin sodium - Oxacillin sodium for injection
Authoritative Data Verified Data
This product is a sterile powder of oxacillin sodium. Oxacillin (C19H19N305S) shall not be less than 90.0% calculated as anhydrous; Oxacillin (C19H19N3O5S) shall be 95.0% ~ 105.0% of label amount calculated as average loading.
trait
This product is white powder or crystalline powder.
identification
take this product, according to oxacillin sodium under the identification of (1), (3) test, showed the same results.
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 of solution, the solution should be clear and colorless (General rule 0901 first method); In case of turbidity, compared with No. 1 turbidity standard solution (General rule 0902 first method), shall not be more concentrated.
- the moisture content of this product shall not exceed 0832 as determined by the method for determination of moisture (General rule 5.5%, first method 1).
- insoluble particles this product is taken, and the labeled amount is added to the particle inspection water to make a solution containing 50mg 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 lOum and more than 10um and no more than 600 particles with 25um and more than 25um in the Og sample; The labeled amount is l.Og or more (including l. (Og) no more than 6000 particles of 10um and 10um in each test sample container, and no more than 600 particles of 25um and 25um.
- the acidity, related substances, oxacillin polymer, bacterial endotoxin and sterility should be checked according to the method of oxacillin sodium.
- except that the difference limit of loading capacity shall not exceed ± 7.0%, all other items shall comply with the relevant provisions under injection (General rule 0102).
Content determination
The content under the item of loading amount difference was obtained by measuring according to the method of oxacillin sodium under the item.
category
with oxacillin sodium.
specification
C19H19N305S (1)0.5g (2)1.0g
storage
sealed and stored in a dry place.
Last Update：2022-01-01 13:34:11
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Raw Materials for Prostaphlin sodium