111696-23-2
Cefetamet Pivoxil HCl
CAS: 111696-23-2
Molecular Formula: C20H26ClN5O7S2
111696-23-2 - Names and Identifiers
111696-23-2 - Physico-chemical Properties
| Molecular Formula | C20H26ClN5O7S2 |
| Molar Mass | 548.03 |
| Boling Point | 732.3°C at 760 mmHg |
| Flash Point | 396.7°C |
| Vapor Presure | 9.78E-22mmHg at 25°C |
| Storage Condition | under inert gas (nitrogen or Argon) at 2-8°C |
111696-23-2 - Standard
Authoritative Data Verified Data
(6R,7R) -3-methyl -7-[ (Z)-2-(2-amino-4-thiazolyl)-2-(methoxyimino) acetamido]-8-oxo-5-thia-1-azabicyclo [4,2, oct-2-ene-2-carboxylic acid pivalyloxymethyl Ester hydrochloride. The content of cefetamet (C14H15N505S2) shall not be less than 69.0% calculated as anhydrous.
Last Update：2024-01-02 23:10:35
111696-23-2 - Trait
Authoritative Data Verified Data
- This product is white to light yellow crystalline powder; Odorless.
- This product is easily soluble in methanol, soluble in ethanol, and almost insoluble in water or ether.
specific rotation
take this product, precision weighing, plus ethanol dissolution and quantitative dilution of the solution containing about 10 mg per 1 ml, according to the law (General 0621), the specific rotation was 78 ° to 86 °.
absorption coefficient
take this product, precision weighing, plus O. 1 mol/L hydrochloric acid solution is dissolved and quantitatively diluted to prepare a solution containing about 14ug per 1 ml, and the absorbance is measured at the wavelength of 263nm by ultraviolet-visible spectrophotometry (General rule 0401), the absorption coefficient is 327 to 347.
Last Update：2022-01-01 14:22:00
111696-23-2 - Preparation solution concentration reference
| 1mg | 5mg | 10mg | |
|---|---|---|---|
| 1 mM | 1.825 ml | 9.124 ml | 18.247 ml |
| 5 mM | 0.365 ml | 1.825 ml | 3.649 ml |
| 10 mM | 0.182 ml | 0.912 ml | 1.825 ml |
| 5 mM | 0.036 ml | 0.182 ml | 0.365 ml |
Last Update：2024-01-02 23:10:35
111696-23-2 - 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 reference product (General rule 0402).
- take 50mg of this product and add 2ml of methanol to dissolve it, and identify the reaction of (1) with chloride (General rule 0301).
Last Update：2022-01-01 14:22:00
111696-23-2 - Exam
Authoritative Data Verified Data
acidity
take this product, add water to make a suspension containing about 10 mg per lml, and determine it according to law (General rule 0631). The pH value should be 2.0~4 .0.
Related substances
take an appropriate amount of this product, add acetonitrile solution (9-20) to dissolve and quantitatively dilute to make a solution containing about 1.4mg per lml as a test solution; Take an appropriate amount for precision measurement, A solution containing about 21ug per 1 ml was prepared as a control solution by quantitative dilution with acetonitrile solution (9-20). According to the chromatographic conditions under the content determination item, take 10ul of the test solution and the control solution respectively, inject the human liquid chromatograph, record the chromatogram to 4 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 (1.5% ) , and the sum of each impurity peak area shall not be greater than 2 times the area of the main peak of the control solution (3.0%).
residual solvent
isopropyl alcohol, ethyl acetate and acetone take about 0.2g of this product, accurately weigh it, place it in the top empty bottle, accurately add 5ml of dimethyl sulfoxide to dissolve it, seal it, and use it as a test solution; accurately weigh the appropriate amount of isopropyl alcohol, ethyl acetate and acetone, and quantitatively dilute with dimethyl sulfoxide to make a mixed solution containing about 0.2mg each in 1 ml. Accurately weigh 5ml, place in a top empty bottle, and seal, as a control solution. According to the determination method of residual solvent (General 0861 second method), the capillary column with polyethylene glycol (PEG-20M) (or similar polarity) as the stationary liquid is used as the column, the initial temperature is 50°C, and the maintenance time is 5 minutes, the temperature was increased to 200°C at a rate of 30°C per minute for 3 minutes; The detector temperature was 250°C; And the inlet temperature was 230°C. The Headspace bottle equilibration temperature was 60°C and the equilibration time was 20 minutes. Take the reference solution into the headspace, record the chromatogram, and the separation degree between peaks shall meet the requirements. The sample solution and the reference solution were sampled by Headspace injection respectively. The chromatogram was recorded and the peak area was calculated according to the external standard method. Isopropyl alcohol, ethyl acetate and acetone residues shall be in accordance with the provisions.
N ,N-dimethylformamide precision weighing
take an appropriate amount of this product, add dimethyl sulfoxide to dissolve and quantitatively dilute to make a solution containing about 50mg per lml, which is the test solution; Weigh an appropriate amount of N ,N-dimethylformamide accurately, A solution containing about 45ug per 1 ml was prepared as a control solution by quantitative dilution with dimethyl sulfoxide. According to the determination method of residual solvent (General Principle 0861 third method), the capillary column with 6% cyanopropyl phenyl-94% dimethyl polysiloxane (or similar polar) as stationary liquid is used as the column; The initial temperature is 100°C, the temperature was maintained for 6 minutes and increased to 200°C at a rate of 30°C per minute for 5 minutes; The detector temperature was 250°C; And the inlet temperature was 230°C. The test solution and the reference solution are respectively injected into the human gas chromatograph to record the chromatogram, and the peak area is calculated according to the external standard method. The residual amount of N,N-dimethylformamide 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 1.0%.
ignition residue
take l.Og of this product and check it according to law (General rule 0841). The residue left shall not exceed 0.2%.
Heavy metals
The residue left under the item of taking the ignition residue shall not contain more than 20 parts per million of heavy metal when examined by law (General rule 0821, Law II).
Last Update：2022-01-01 14:22:01
111696-23-2 - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with OCTA alkyl silane as filler; Acetonitrile-methanol-water-phosphate buffer (take anhydrous disodium hydrogen phosphate 5.8g and potassium dihydrogen phosphate 3.5g, add water to dissolve and dilute to 360) (: 95:500:45) as mobile phase; The detection wavelength was 263nm. Take appropriate amount of cefetamet acid reference and cefetamet pivoxil reference, add acetonitrile solution (9-20) dissolve and dilute to prepare a mixed solution containing about 0.05mg of cefetamet pivoxil and 1.4mg of cefetamet pivoxil per 1 ml, the retention time of cefetamet pivoxil peak is about 12 minutes, and the resolution between cefetamet pivoxil peak and cefetamet pivoxil peak should be greater than 28.0, the separation degree between the peak of cefetamet pivoxil and the impurity peak at the relative retention time of about 0.9 and 1.1 should be greater than 2.0.
assay
take an appropriate amount of this product, weigh it accurately, add acetonitrile solution (9-20) to dissolve and quantitatively dilute to make a solution containing about 0.28mg per lml as the test solution, lOul was injected into human liquid chromatograph accurately, and the chromatogram was recorded. Another reference substance of cefetamet pivoxil was taken and determined by the same method. The content of cefetamet (C14H15N505S2) in the test product was calculated by peak area according to external standard method.
Last Update：2022-01-01 14:22:03
111696-23-2 - Category
Authoritative Data Verified Data
B-lactam antibiotics, cephalosporins.
Last Update：2022-01-01 14:22:03
111696-23-2 - Storage
Authoritative Data Verified Data
light shielding, sealed, stored in a cool and dry place.
Last Update：2022-01-01 14:22:04
111696-23-2 - Cefetamet pivoxil hydrochloride for suspension
Authoritative Data Verified Data
This product contains cefetamet pivoxil hydrochloride according to cefetamet (C14H15N505S2) calculation, should be 90.0% ~ 120.0% of the label amount.
trait
This product is white to light yellow powder; Aromatic.
identification
- take an appropriate amount of the contents of this product, and add anhydrous ethanol to make a solution containing about 12.5mg of cefetamet per 1 ml, and let stand, and take the supernatant as the test solution; an appropriate amount of cefetamet pivoxil control was taken and anhydrous ethanol was added to prepare a solution containing about 12.5mg of cefetamet maleate per 1 ml as a control solution. According to the thin layer chromatography (General 0502) test, absorb the above two solutions each 2 u1, respectively point on the same silica gel GF254 thin layer plate, with ethyl acetate-ether-methylene chloride-formic acid (5:4:5:4) is a developing solvent, which is developed, dried, and colored in iodine vapor. 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 the content of this product (about equivalent to cefetamet 35mg), add methanol 2ml, shake to dissolve cefetamet pivoxil hydrochloride, filter, filtrate chloride identification (1) response (General rule 0301).
- two items (1) and (2) above can be selected as one item.
examination
- Related substances take an appropriate amount of the contents of this product, add acetonitrile solution (9-20) to dissolve and quantitatively dilute to make about cefetamet l per 1 ml. 0 mg of the solution, filtered, take the continued filtrate as the test solution; Precise amount of appropriate amount, with acetonitrile solution (9-20) quantitative dilution to make a solution containing about 20ug of cefetamet per 1 ml, as a control solution. According to the method under cefetamet pivoxil hydrochloride, except for the peak before the relative retention time of 0.20, the peak area of single impurity shall not be greater than the main peak area of the control solution (2.0%), the sum of each impurity peak area shall not be greater than 2.5 times (5.0%) of the main peak area of the control solution.
- water the content of this product should be taken in an appropriate amount, and the water content should not exceed 0832 as determined by the moisture determination method (General rule 2.0%, first method 1).
- dissolution of this product, according to the dissolution and release determination method (General 0931 second method), to O. 900ml of lmol /L hydrochloric acid solution is the dissolution medium, and the rotation speed is 50 revolutions per minute. The operation is carried out according to law. After 30 minutes, the appropriate amount of the solution is taken, filtered, and the appropriate amount of the filtrate is taken, A solution containing about 10ug of cefetamet per 1 ml was prepared by quantitative dilution with dissolution medium, and the absorbance was measured at the wavelength of 263mn by ultraviolet-visible spectrophotometry (General rule 0401), in addition, an appropriate amount of cefetamet pivoxil reference substance was accurately weighed, dissolved and quantitatively diluted with dissolution medium to prepare a solution containing about 10ug of cefetamet pivoxil per 1 ml, which was determined by the same method. The dissolution of each bag was calculated. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
- other than sedimentation volume ratio (single dose package), should comply with the relevant provisions under the item of oral suspension (General Principle 0123).
Content determination
take the contents under the difference of loading amount, mix evenly, weigh an appropriate amount (about 0.lg equivalent to cefetamet), put it in a 100ml measuring flask, and add acetonitrile solution (9-20). The appropriate amount of cefetamet pivoxil hydrochloride was dissolved and diluted to the scale by shaking, and then filtered. A solution containing about 0.2mg of cefetamet per 1 ml was prepared by quantitative dilution as a test solution, which was determined according to the method under the item cefetamet pivoxil hydrochloride.
category
Same as cefetamet pivoxil hydrochloride.
specification
Based on C14H15N505S2 (1)90.65mg(2)181.3mg
storage
shade, Seal, store in a cool and dry place
Last Update：2022-01-01 14:22:04
111696-23-2 - Cefetamet hydrochloride tablets
Authoritative Data Verified Data
This product contains cefetamet pivoxil hydrochloride according to cefetamet (C14H15N505S2) calculation, should be 90.0% ~ 110.0% of the label amount.
trait
This product is a film-coated tablet, white to light yellow after removing the coating.
identification
- take an appropriate amount of fine powder of this product, add anhydrous ethanol to dissolve and dilute to prepare a solution containing about 12.5mg of cefetamet per 1 ml, stand still, and take the supernatant as the test solution; an appropriate amount of cefetamet pivoxil control was taken and anhydrous ethanol was added to prepare a solution containing about 12.5mg of cefetamet maleate per 1 ml as a control solution. According to the thin layer chromatography (General 0502) test, absorb the above two solutions each 2 u1, respectively, on the same silica gel GFZ54 thin layer plate, with ethyl acetate-ether-methylene chloride-formic acid (5:4:5:4) is a developing solvent, which is developed, dried, and colored in iodine vapor. 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 fine powder of this product and add 0. Cefetamet pivoxil hydrochloride was dissolved by shaking with 1 mol/ L hydrochloric acid solution and diluted to prepare a solution containing cefetamet contaminated g per 1 ml, there is an absorption maximum at a wavelength of 0401 nm as determined by UV-Vis spectrophotometry (general).
- Take appropriate amount of fine powder of this product (about equivalent to cefetamet 35mg), add 2ml of methanol, shake to dissolve cefetamet pivoxil hydrochloride, filter, filtrate chlorides identification (1) response (General rule 0301).
- two items (1) and (2) above can be selected as one item.
examination
- Related substances take an appropriate amount of fine powder of this product, add acetonitrile solution (9-20) to dissolve and quantitatively dilute to prepare about cefetamet l per lml. 0 mg of the solution, filtered, take the continued filtrate as the test solution; Precise amount of appropriate amount, with acetonitrile solution (9-20) quantitative dilution to make a solution containing about 20ug of cefetamet per 1 ml, as a control solution. According to the method of cefetamet pivoxil hydrochloride, the peak area of single impurity shall not be greater than the main peak area of the control solution (2.0%), the sum of each impurity peak area shall not be greater than 2.5 times (5.0%) of the main peak area of the control solution.
- dissolution of this product, according to the dissolution and release determination method (General 0931 second method), with 0.900ml of 1 mol /L hydrochloric acid solution is the dissolution medium, and the rotation speed is 75 RPM. The operation is carried out according to law. After 45 minutes, the appropriate amount of the solution is taken, filtered, and the appropriate amount of the filtrate is taken, A solution containing about 10ug of cefetamet per 1 ml was prepared by quantitative dilution with dissolution medium, and the absorbance was measured at the wavelength of 0401 nm by UV-Vis spectrophotometry (general rule), in addition, an appropriate amount of cefetamet pivoxil reference substance was accurately weighed, dissolved and quantitatively diluted with dissolution medium to prepare a solution containing about 10ug of cefetamet pivoxil per 1 ml, which was determined by the same method. The dissolution amount of each tablet was calculated. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
- 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, precision weighing, fine grinding, precision weighing appropriate amount (about equivalent to cefetamet 0.lg), put it in 50ml measuring flask, add acetonitrile solution (9-20) appropriate amount, shake to dissolve cefetamet pivoxil hydrochloride and dilute to the scale, shake, filter, take the appropriate amount of filtrate, with acetonitrile solution (9-20) A solution containing about 0.2mg of cefetamet per 1 ml was prepared by quantitative dilution as a test solution, which was determined according to the method under the item cefetamet pivoxil hydrochloride.
category
Same as cefetamet pivoxil hydrochloride.
specification
Based on C14H15N505S2 (1)90.65mg(2)181.3mg
storage
light shielding, sealed, stored in a cool and dry place.
Last Update：2022-01-01 14:22:05
111696-23-2 - Cefetamet pivoxil hydrochloride capsules
Authoritative Data Verified Data
This product contains cefetamet pivoxil hydrochloride according to cefetamet (C14H15N505S2) calculation, should be 90.0% ~ 110.0% of the label amount.
trait
The content of this product is white to light yellow powder or granules.
identification
- take an appropriate amount of the contents of this product, add anhydrous ethanol to dissolve and dilute to prepare a solution containing about 12.5mg of cefetamet per 1 ml, stand still, and take the supernatant as the test solution; an appropriate amount of cefetamet pivoxil control was taken and anhydrous ethanol was added to prepare a solution containing about 12.5mg of cefetamet maleate per 1 ml as a control solution. According to the thin layer chromatography (General 0502) test, absorb the above two solutions each 2 u1, respectively point on the same silica gel GF254 thin layer plate, with ethyl acetate-ether-methylene chloride-formic acid (5:4:5:4) is a developing solvent, which is developed, dried, and colored in iodine vapor. 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 the contents of this product and add 0.lmol/ L hydrochloric acid solution was shaken to dissolve cefetamet pivoxil hydrochloride and diluted to prepare a solution containing about 10ug cefetamet per lml, there is an absorption maximum at a wavelength of 0401 nm as determined by UV-Vis spectrophotometry (general).
- take an appropriate amount of the content of this product (about equivalent to cefetamet 35mg), add methanol 2ml, shake to dissolve cefetamet pivoxil hydrochloride, filter, filtrate chloride identification (1) response (General rule 0301).
- two items (1) and (2) above can be selected as one item.
examination
- Related substances take an appropriate amount of the contents of this product, add acetonitrile solution (9-20) to dissolve and quantitatively dilute to make about cefetamet l per 1 ml. 0 mg of the solution, filtered, take the continued filtrate as the test solution; Precise amount of appropriate amount, with acetonitrile solution (9-20) quantitative dilution to make a solution containing about 20ug of cefetamet per 1 ml, as a control solution. According to the method of cefetamet pivoxil hydrochloride, the peak area of single impurity shall not be greater than the main peak area of the control solution (2.0%), the sum of each impurity peak area shall not be greater than 2.5 times (5.0%) of the main peak area of the control solution.
- water the content of this product should be taken in an appropriate amount, and the water content should not exceed 0832 as determined by the moisture determination method (General rule 3.0%, first method 1).
- dissolution of this product, according to the dissolution and release determination method (General 0931 first method), with 0.100 ml of lmol/ L hydrochloric acid solution is the dissolution medium, the rotation speed is revolutions per minute, and the operation is carried out according to law. After 30 minutes, the appropriate amount of the solution is taken, filtered, and the appropriate amount of the filtrate is taken, A solution containing about 10ug of cefetamet per 1 ml was prepared by quantitative dilution with dissolution medium, and the absorbance was measured at the wavelength of 263mn by ultraviolet-visible spectrophotometry (General rule 0401), in addition, an appropriate amount of cefetamet pivoxil reference substance was accurately weighed, dissolved and quantitatively diluted with dissolution medium to prepare a solution containing cefetamet contaminated g per 1 ml, which was determined by the same method. The amount of dissolution per pellet was calculated. The limit is 85% 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 loading amount difference, mix evenly, accurately weigh the appropriate amount (about equivalent to cefetamet O.lg ) , put it in a 50ml measuring flask, add an appropriate amount of acetonitrile solution (9-20), shake to dissolve cefetamet pivoxil hydrochloride and dilute to the scale, shake well, filter, accurately take appropriate amount of filtrate, and quantitatively dilute with acetonitrile solution (9-20) to prepare a solution containing about 0.2mg of cefetamet per 1 ml as a test solution, according to cefetamet pivoxil hydrochloride under the determination of the method.
category
Same as cefetamet pivoxil hydrochloride.
specification
Based on C14H15N505S2 (1)90.65mg(2)181.3mg
storage
light shielding, sealed, stored in a cool and dry place.
Last Update：2022-01-01 14:22:06
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Tel: +86 0571-86722205
Email: sales@chinaskyrun.com
Mobile: +8618958170122
QQ: 2531159185
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Product Name: Ro 15-8075 Visit Supplier Webpage Request for quotationCAS: 111696-23-2
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Mobile: 609-228-6898
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Email: product@acmec-e.com
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View History
111696-23-2
224-42-0
XANTHOSINE
2-(Trimethylsilyl)ethoxymethyl chloride
219944-39-5
Hexahydro-3-methyl-2H-azepin-2-one
FAST GREEN
Methyl 4-(4-formylphenyl)benzoate
3,5-Dimethylpyrazole-4-carboxylic acid ethyl ester
methoxyammonium chloride
224-42-0
XANTHOSINE
2-(Trimethylsilyl)ethoxymethyl chloride
219944-39-5
Hexahydro-3-methyl-2H-azepin-2-one
FAST GREEN
Methyl 4-(4-formylphenyl)benzoate
3,5-Dimethylpyrazole-4-carboxylic acid ethyl ester
methoxyammonium chloride