CEFAMANDOLE SODIUM
cefamandole sodium
CAS: 30034-03-8
Molecular Formula: C18H17N6NaO5S2
CEFAMANDOLE SODIUM - Names and Identifiers
CEFAMANDOLE SODIUM - Physico-chemical Properties
| Molecular Formula | C18H17N6NaO5S2 |
| Molar Mass | 484.48 |
| Melting Point | >175°C (dec.) |
| Solubility | DMSO (Slightly), Methanol (Slightly), Water (Slightly) |
| Appearance | Solid |
| Color | White to Pale Yellow |
| Storage Condition | Store at RT. |
| Stability | Moisture Sensitive |
| Use | For antibiotics |
CEFAMANDOLE SODIUM - Risk and Safety
| Hazard Symbols | Xn - Harmful |
| Risk Codes | R36/37/38 - Irritating to eyes, respiratory system and skin. R42/43 - May cause sensitization by inhalation and skin contact. |
| Safety Description | S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S36 - Wear suitable protective clothing. |
| WGK Germany | 2 |
| RTECS | XI0389000 |
CEFAMANDOLE SODIUM - Standard
Authoritative Data Verified Data
(6R,7R)-7-(R)-(2-formyloxy-2-phenylacetamido)-3-[[(1-methyl-1h-tetrazol-5-yl) thioyl] methyl]-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid sodium salt; Calculated as anhydrous, containing cefamandole (C18H18N605S2) should be 84.0% ~ 93.0%.
Last Update：2024-01-02 23:10:35
CEFAMANDOLE SODIUM - Trait
Authoritative Data Verified Data
- This product is white or white crystalline powder; Odorless; Easy to wet.
- This product is soluble in water, slightly soluble in methanol, insoluble in ethanol or ether.
specific rotation
take this product, precision weighing, adding water to dissolve and quantitatively dilute to make about O in each lml. 1g of the solution, measured according to the law (General rule 0621), the specific rotation is -35.0 ° to -44.0 °.
Last Update：2022-01-01 11:40:28
CEFAMANDOLE SODIUM - Differential diagnosis
Authoritative Data Verified Data
- take this product and cefamandole Ester sodium reference, respectively, and add the developer to make a solution containing about 2mg per 1 ml, as the test solution and the reference solution, according to the thin layer chromatography (General 0502) test, absorb the above two Solutions respectively point on the same silica gel GF254 thin layer plate, with ethyl acetate-acetone-glacial acetic acid-water (5:2:1:1) for the development of the agent, expand, dry, set the UV lamp (254nm) under the view, 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 this product and add water to make a solution containing about 20ug per 1 ml. According to UV-visible spectrophotometry (General 0401), there is a maximum absorption at the wavelength of 269mn.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 125).
- This product shows the reaction of sodium salt identification (1) (General rule 0301).
- two items (1) and (2) above can be selected as one item.
Last Update：2022-01-01 11:40:28
CEFAMANDOLE SODIUM - Exam
Authoritative Data Verified Data
acidity
take this product, add water to make a solution containing O.lg per lml, and determine it according to law (General 0631). The pH value should be 4.0~6.5.
clarity of the solution
take an appropriate amount of this product, add water to dissolve and dilute to make about 0.lg of the solution, the solution should be clear; If it is turbid, compared with No. 1 turbidity standard solution (General 0902 first method), should not be more concentrated.
absorbance
take an appropriate amount of this product, add water to dissolve and dilute it to make it contain O in each lml. lg of the solution, according to UV-visible spectrophotometry (General rule 0401), determination of absorbance at 475nm wavelength, not more than 0.03.
cefamandole
take this product, according to the method under the item of content determination, according to the calculation of anhydrous, containing cephalosporin more than 9.5% of the total content.
Related substances
take an appropriate amount of this product, add the mobile phase to dissolve and dilute to make a solution containing about 0.5mg per lml as a test solution; Take 1ml for precision measurement and put it in a 100ml measuring flask, dilute to the scale with the mobile phase, shake, and serve as a control solution. According to the chromatographic conditions under the item of Holter determination, 20 u1 of each of the test solution and the control solution are accurately measured and injected into the human liquid chromatograph respectively, the chromatogram was recorded to 2 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 that of the control solution (1.0%) except for the cefamandin multi-peak, the sum of the peak areas of each impurity shall not be greater than 3.0 times (3.0%) the area of the control solution.
residual solvent
take about 0.2g of this product, precision weighing, set in the top empty bottle, Precision Add 2ml of water to dissolve, seal, as a test solution; Respectively, precision weigh the appropriate amount of each solvent, quantitatively diluted with water to make each 1 ml containing ether 0.5mg, acetone 0.5mg, ethyl acetate 0.5mg, methanol 0.3mg, isopropanol 0.5mg, ethanol 0.5mg, methyl isobutyl ketone 0.5mg, A mixed solution of 0.089mg of toluene and 0.5mg of n-butanol was precisely weighed into 2ml, placed in a headspace bottle, and sealed as a reference solution. According to the test for determination of residual solvents (General rule 0861 second method), the capillary column with Nitro-terephthalic acid-modified polyethylene glycol (PEG-20M)(or similar polarity) as stationary liquid is used as the chromatographic column, the initial temperature is 60°C, maintained for 6 minutes, then increased to 150°C at a rate of 20°C per minute, maintained for 8 minutes; The inlet temperature is 150°C; The detector temperature is 250°C; the Headspace bottle equilibration temperature was 80°C and the equilibration time was 30 minutes. Take the reference solution into the headspace, ether, acetone, ethyl acetate, methanol, isopropanol, ethanol, methyl isobutyl ketone, toluene and n-butanol peak sequentially, the separation degree between the main peaks should meet the requirements. The test solution and the reference solution were injected into the headspace respectively, and the chromatogram was recorded, and the peak area was calculated according to the external standard method. Ether, acetone, ethyl acetate, methanol, isopropanol, ethanol, methyl isobutyl ketone, toluene and n-butanol residues shall be in accordance with the provisions.
2-ethylhexanoic acid
take this product, determination according to law (General Principles 0873 ), not over 0.3%.
moisture
take this product, according to the moisture determination method (General 0832 first method 1), the water content shall not exceed 1.0%.
visible foreign body
take 5 parts of this product, each part is the maximum specification of the preparation, respectively, 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, respectively, and add particles to check water to dissolve and make a solution containing 30mg per lml, and check according to law (General rule 0903), no more than 6000 particles of 10um and more than 10um in each lg sample, and no more than 600 particles of 25um and more than 25um. (For aseptic dispensing)
Heavy metals
This product l.Og, inspection according to law (General Principles 0821 The first law), containing heavy metals shall not exceed 10 parts per million.
bacterial endotoxin
take this product, check according to law (General rule 1143), the amount of endotoxin per 1 mg cefamandole should be less than 0.15EU. (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 11:40:30
CEFAMANDOLE SODIUM - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with octylsilane was used as a filler; 1% triethylamine solution (adjusted to pH 2.5 with phosphoric acid)-acetonitrile (70:30) was used as a mobile phase, and the detection wavelength was 254nm. Take an appropriate amount of cefamandole sodium reference, add mobile phase to dissolve and dilute to make a solution containing about 50ug per 1 ml, place it in a water bath at 60°C for 30 minutes, remove it and let it cool, take 20u1 injection human liquid chromatograph, record the chromatogram, the separation degree between cefamandole peak and cefamandole sodium peak should be greater than 7.0, the separation degree between two main peaks and adjacent impurity peaks should meet the requirements.
assay
take this product, precision weighing, plus mobile phase dissolution and quantitative dilution made from each lml containing cefamandole 0.lmg solution, as a test solution, the precision of 20u1 injection of human liquid chromatography, record the chromatogram; Another appropriate amount of cefamandole Ester sodium reference, the same method for determination, according to the external standard method, the content of cefamandole sodium (C18H18N6O5S2) and the content of cefamandole sodium (C18H18N6O5S2) in the sample were calculated by peak area, the sum of the two is the content of cefamandole (C18H18N605S2) in the test product.
Last Update：2022-01-01 11:40:31
CEFAMANDOLE SODIUM - Category
Authoritative Data Verified Data
B-lactam antibiotics, cephalosporins.
Last Update：2022-01-01 11:40:31
CEFAMANDOLE SODIUM - Storage
Authoritative Data Verified Data
cefamandole sodium for injection
Last Update：2022-01-01 11:40:31
CEFAMANDOLE SODIUM - Cefamandole Ester sodium for injection
Authoritative Data Verified Data
This product is cefamandole Ester sodium sterile powder. The content of cefamandole (C18H18N6O5S2) shall be 84.0% ~ 93.0% based on the calculation of no water; The content of cefamandole (C18H18N6O5S2) shall be 90.0% ~ 110.0% of the labeled amount based on the average loading.
trait
This product is white or off-white crystalline powder.
identification
take this product, according to cefamandole Ester sodium under the identification 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 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 than the yellow or yellow-green standard colorimetric solution No. 5 (general rule 0901 method 1).
- the moisture content of this product shall not exceed 0832 as determined by the method for determination of moisture (General rule 1.5%, first method 1).
- insoluble particles take this product, according to the label amount and particle inspection water to make a solution containing 30mg per 1 ml, according to the law (General rule 0903), the label amount is l. The conversion below Og is per l. No more than 6000 particles of 10um and more than 10um and no more than 600 particles of 25um and more than 25ul in the Og sample; The labeled amount is l.Og or more (including l.Og) no more than 6000 particles of 10um and lOum in each sample container, and no more than 600 particles of 25um and 25um.
- acidity, cefamandole, related substances, bacterial endotoxin and sterility shall be tested according to the method under the item of cefamandole sodium.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
The contents under the item of loading amount difference were accurately weighed and the appropriate amount was measured according to the method of cefamandole sodium ester.
category
Same as cefamandole sodium.
specification
Based on C18H18N605S2 (1)0.5g (2)1.0g(3)1.5g (4)2.0g
storage
sealed and stored in a cool, dark and dry place.
Last Update：2022-01-01 11:40:32
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QQ: 3008007409
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Spot supply
Product Name: Cefamandole Sodium Salt Visit Supplier Webpage Request for quotationCAS: 30034-03-8
Tel: 0714-3999186
Email: 2853786052@qq.com
Mobile: 86+15671228036
QQ: 2853786052
Wechat: 15671228036
Product Name: Cefamandole Sodium Salt Visit Supplier Webpage Request for quotation
CAS: 30034-03-8
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
CAS: 30034-03-8
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
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