AMIKACIN
Amikacin
CAS: 37517-28-5
Molecular Formula: C22H43N5O13
AMIKACIN - Names and Identifiers
AMIKACIN - Physico-chemical Properties
| Molecular Formula | C22H43N5O13 |
| Molar Mass | 585.6 |
| Density | 1.3764 (rough estimate) |
| Melting Point | 203℃ |
| Boling Point | 642.23°C (rough estimate) |
| Specific Rotation(α) | D23 +99° (c = 1.0 in water) |
| Water Solubility | Soluble in water (partly). |
| Solubility | H2O: 50mg/mL, clear, colorless |
| Appearance | solid |
| Color | white to off-white |
| Merck | 13,404 |
| BRN | 1445422 |
| pKa | pKa 8.1 (Uncertain) |
| Storage Condition | 2-8°C |
| Stability | Hygroscopic |
| Refractive Index | 1.7500 (estimate) |
| Physical and Chemical Properties | White crystalline powder, almost odorless, tasteless. Very soluble in water, insoluble in methanol, propanol, ether and other organic solvents. Aminoglycoside antibiotics. |
| Use | For the kanamycin, Gentamicin-resistant strains caused by urinary tract, lung and other infections, and green pus, deformation and other bacteria caused by sepsis. |
AMIKACIN - Risk and Safety
| Hazard Symbols | Xi - Irritant |
| Risk Codes | 36/37/38 - Irritating to eyes, respiratory system and skin. |
| Safety Description | S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S36 - Wear suitable protective clothing. S24/25 - Avoid contact with skin and eyes. |
| WGK Germany | 2 |
| RTECS | WK1955000 |
| FLUKA BRAND F CODES | 10-34 |
| HS Code | 29419090 |
| Toxicity | LD50 in mice of solns pH 6.6, pH 7.4 (mg/kg): 340, 560 i.v. (Kawaguchi) |
AMIKACIN - Reference
| Reference Show more | Zhao Suhua, fan Hongjie. Serotype identification and drug resistance analysis of avian Escherichia coli in northern Anhui [J]. Animal husbandry and veterinary medicine, 2017, 49(004):95-98. |
AMIKACIN - Standard
Authoritative Data Verified Data
This product is 03-amino -3-deoxy-a-D-glucopyranosyl-(l-4)-0[6-amino -6-deoxy-a-D-glucopyranosyl-(1-6) ]-N3-(4-amino-2-hydroxy-1-oxobutyl)-2-deoxy-l-streptavidin. Amikacin (C22H43N5013) should be 95.0% to 102.0% based on the dry product.
Last Update：2024-01-02 23:10:35
AMIKACIN - Trait
Authoritative Data Verified Data
- This product is white or off-white powder or crystalline powder; Almost odorless.
- This product is soluble in water and almost insoluble in ethanol.
specific rotation
take this product, precision weighing, water dissolution and quantitative dilution of about 20mg per lml solution, according to the law (General 0621), specific rotation of 97 ° to 105 °.
Last Update：2022-01-01 12:00:05
AMIKACIN - Differential diagnosis
Authoritative Data Verified Data
- take about 10mg of this product, add water lm l to dissolve, add 0.1% anthrone sulfuric acid solution 4ml, that is blue purple.
- take about 10mg of this product, add water lm l to dissolve, add 4% sodium hydroxide solution 1ml, mix, add 5% cobalt nitrate solution 2ml, and produce purple-blue flocculent precipitate.
- a solution containing about 5mg of amikacin per 1 ml is prepared by adding water in appropriate amounts of the product and the reference product of amikacin, and used as the test solution and the reference solution; the test solution and the control solution were mixed in equal amounts as a mixed solution. According to the thin layer chromatography condition test under the kanamycin examination item, the position and color of the main spot of the test solution should be the same as the position and color of the main spot of the reference solution, the mixed solution showed single spot.
- 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.
- two items (3) and (4) above can be selected as one item.
Last Update：2022-01-01 12:00:05
AMIKACIN - Exam
Authoritative Data Verified Data
alkalinity
take this product O.lg, add water 10ml to dissolve, according to the law to determine (General 0631),pH value should be 9.5~11.5.
clarity and color of solution
take 5 parts of this product, each 0.6g, add 0.5mol/L sulfuric acid solution 5ml to dissolve, the solution should be clear and colorless; If it is turbid, no one shall be more concentrated than the turbidity standard liquid No. 1 (General rule 0902 method 1), and no one shall be deeper than the yellow or yellow-green standard colorimetric liquid No. 2 (General rule 0901 method 1) in case of color development.
Related substances
take an appropriate amount of this product, add mobile phase A to dissolve and dilute to make about 5.0 mg of the solution, as the test solution; Precision take the appropriate amount, diluted with mobile phase A to make A solution containing about 50ug per 1 ml, as A control solution; according to the high performance liquid chromatography method (General rule 0512) test, with the ten alkyl silicon bonded silica gel as the filler (sprsil column, mm x mm,5um or equivalent performance column); take sodium octane sulfonate 20.0g and anhydrous sodium sulfate 0.2g, add 0.2mol/L phosphate buffer solution (0.2mol/L potassium dihydrogen phosphate solution, adjust the pH value to 3.0 with mol/L phosphoric acid solution) 50ml and water 20.0 ML, add acetonitrile 50ml, mix, as mobile phase A; Take sodium octane sulfonate 3.0g and anhydrous sodium sulfate 0.2g, add pH mol/L phosphate buffer solution 50ml and water 850ml, dissolve, acetonitrile (ml) was added and mixed well as mobile phase B at a flow rate of 1.3ml per minute; Linear gradient elution was carried out as follows; Column temperature was 40 ° C.; Detection wavelength was 200nm. Take the appropriate amount of amikacin control, add the mobile phase to dissolve and dilute to make about 5.0 mg solution, take 10u1 injection human liquid chromatograph, record chromatogram, amikacin peak retention time should be between 20~30 minutes (if necessary, adjust the proportion of mobile phase A and mobile phase B), the resolution between amikacin peak and impurity B Peak (relative retention time about 0.92) should meet the requirements. l0ul of the test solution and the control solution were accurately measured and injected into the human liquid chromatograph respectively, and the chromatograms were recorded. If there are impurity peaks in the chromatogram of the test solution, impurity F (relative retention time is about 0.89) and impurity A (relative retention time is about 1.60, if necessary, confirm with impurity A reference substance) and impurity H (relative retention time is about 2.44) are not greater than the main peak area of the control solution (1.0%), impurity B and impurity E (relative retention time is about 1.41) all shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution, and the peak area of other individual impurities shall not be greater than the main peak area of the control solution (1.0%), 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.
kanamycin
take this product, add water to dissolve and dilute to make a solution containing about 25mg per 1 ml, as a test solution; Precision weigh the appropriate amount of kanamycin reference, add water to dissolve and dilute to make a solution containing about 0.25mg per 1 ml, as a control solution; Take the appropriate amount of amikacin and kanamycin control, A solution containing about 25mg of amikacin and 0.75mg of kanamycin, respectively, per 1 ml was prepared by dissolving and diluting with water as a control mixed solution. According to the thin layer chromatography (General 0502) test, absorb 5 u1 of each of the above three solutions, respectively point on the same silica gel G thin layer plate, with dichloromethane-methanol-concentrated ammonia solution (25:40:30) as a developing solvent, it was developed, dried, sprayed with 0.2% ninhydrin in water-saturated n-butanol solution, and heated at 100 ° C. For several minutes. The amikacin and kanamycin spots in the control mixture solution should be completely separated. Test solution such as kanamycin spot, compared with the control solution of the main spot, not deeper (1%).
residual solvent
take about 0.2g of this product, precision weighing, set in the top empty bottle, Precision Add 5ml of water to dissolve, seal, as a test solution; Precision weighing methanol, ethanol, the appropriate amount of acetone and acetonitrile is quantitatively diluted with water to make a mixed solution containing about 0.12mg of methanol, 0.2mg of ethanol, 0.2mg of acetone and 0.016mg of acetonitrile in each lml, and 5ml is accurately measured and placed in the top empty bottle, sealed as a control solution. According to the determination method of residual solvent (General Principle 0861 first method), the capillary column with 6% cyanopropylphenyl-94% dimethyl polysiloxane (or similar polarity) as the stationary liquid is the column; The column temperature is 40°C; the inlet temperature was 140°C; The detector temperature was 2501; The headspace bottle equilibrium temperature was 80°C and the equilibrium time was 30 minutes. The separation degree between the main peaks shall meet the requirements when the reference solution is injected in the headspace. The test solution and the reference solution are injected in Headspace respectively, and the chromatogram is recorded. The residual amount of methanol, ethanol, prilam and acetonitrile shall be calculated by the peak area according to the external standard method.
loss on drying
take this product, dry to constant weight at 120°C, weight loss shall not exceed 7.0% (General rule 0831).
ignition residue
0841 (general).
bacterial endotoxin
take this product, check according to law (General rule 1143), the amount of endotoxin per 1 mg amikacin should be less than 0.33EU. (For injection)
Last Update：2022-01-01 12:00:06
AMIKACIN - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with octanoalkyl silane as filler (sprsil column, 4.6mm X 250mm,5um or equivalent column); Sodium octane sulfonate 20.0g and anhydrous sodium sulfate g, add 3.0 mol/L phosphate buffer solution of pH 0.2 (0.2mol/L potassium dihydrogen phosphate solution, adjust pH to 0.2 with 3.0 mol/L phosphoric acid solution), dissolve 50ml and 875ml of water, add 75ml of acetonitrile, the mixture was homogenized as a mobile phase; The flow rate was 1.3ml per minute; The column temperature was 40 ° C.; And the detection wavelength was 200nm. Take the amikacin reference solution 10u1 and inject it into human liquid chromatograph to record the chromatogram. The retention time of amikacin peak should be between 20 and 30 minutes, and the separation degree between amikacin peak and adjacent impurity peaks should meet the requirements.
assay
take an appropriate amount of this product, precision weigh, add mobile phase to dissolve and dilute to make a solution containing about 2.5mg per 1 ml, as a test solution, take a precision amount of 10ul and inject it into the human liquid chromatograph, record the chromatogram; Take an appropriate amount of amikacin reference, the same method for determination. According to the external standard method to calculate the peak area, that is. 1 mg is equivalent to 1000 amikacin units.
Last Update：2022-01-01 12:00:07
AMIKACIN - Category
Authoritative Data Verified Data
helium glycoside antibiotics.
Last Update：2022-01-01 12:00:08
AMIKACIN - Storage
Authoritative Data Verified Data
sealed and stored in a dry place.
Last Update：2022-01-01 12:00:08
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