4-[2,6-diamino-2,3,6-trideoxy-alpha-d-glycopyranosyl]-6-[3-amino-3-deoxy-alpha
tobramycin
CAS: 32986-56-4
Molecular Formula: C18H37N5O9
4-[2,6-diamino-2,3,6-trideoxy-alpha-d-glycopyranosyl]-6-[3-amino-3-deoxy-alpha - Names and Identifiers
| Name | tobramycin |
| Synonyms | tobramycin Tobramycin 1-epitobramycin Tobramycin Base 3'-deoxykanamycinb Tobramycin, Free Base d-6-trideoxy-alpha-d-ribohexopyranosyl-(1-6))-2-deoxy 6-trideoxy-alpha-d-ribo-hexopyranosyl-(1-4))-2-deoxy- d-6-tyrideoxy-alpha-d-ribohexopyranosyl-(1-6))-2-deoxy 4-[2,6-diamino-2,3,6-trideoxy-alpha-d-glycopyranosyl]-6-[3-amino-3-deoxy-alpha O-[3-Amino-3-deoxy-α-D-glucopyranosyl-(1→6)]-O-[2,6-diamino-2,3,6-trideoxy-α-D-ribohexopyranosyl-(1→4)]-2-deoxy-D-streptamine 4-amino-2-[4,6-diamino-3-[[2-amino-5-(aminomethyl)-4-hydroxy-cyclohexyl]methyl]-2-hydroxy-cyclohexoxy]-6-(hydroxymethyl)tetrahydropyran-3,5-diol (1S,2S,3R,4S,6R)-4,6-diamino-3-[(2,6-diamino-2,3,6-trideoxy-alpha-D-ribo-hexopyranosyl)oxy]-2-hydroxycyclohexyl 3-amino-3-deoxy-alpha-D-glucopyranoside |
| CAS | 32986-56-4 |
| EINECS | 251-322-5 |
| InChI | InChI=1/C20H41N5O7/c21-5-8-1-7(10(22)4-13(8)27)2-9-11(23)3-12(24)19(16(9)28)32-20-18(30)15(25)17(29)14(6-26)31-20/h7-20,26-30H,1-6,21-25H2 |
4-[2,6-diamino-2,3,6-trideoxy-alpha-d-glycopyranosyl]-6-[3-amino-3-deoxy-alpha - Physico-chemical Properties
| Molecular Formula | C18H37N5O9 |
| Molar Mass | 467.52 |
| Density | 1.3458 (rough estimate) |
| Melting Point | 178 °C |
| Boling Point | 570.01°C (rough estimate) |
| Specific Rotation(α) | D20 +129° (c = 1 in water) |
| Flash Point | 402.3°C |
| Water Solubility | Soluble in water |
| Solubility | Soluble in water (94 mg/ml at 25 °C), ethanol (<1 mg/ml at 25 °C), DMSO (<1 mg/ml a |
| Vapor Presure | 2.18E-25mmHg at 25°C |
| Appearance | White to off-white solid |
| Color | white to off-white |
| Merck | 14,9490 |
| BRN | 1357507 |
| pKa | pKa 6.7 (Uncertain);8.3 (Uncertain);9.9 (Uncertain) |
| Storage Condition | Keep in dark place,Inert atmosphere,2-8°C |
| Sensitive | Easily absorbing moisture |
| Refractive Index | 143 ° (C=4, H2O) |
| MDL | MFCD00077885 |
| Use | Broad-spectrum antibiotic similar to gentamicin, highly active against gram-negative bacilli |
4-[2,6-diamino-2,3,6-trideoxy-alpha-d-glycopyranosyl]-6-[3-amino-3-deoxy-alpha - 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. S37/39 - Wear suitable gloves and eye/face protection |
| WGK Germany | 2 |
| RTECS | WK2100000 |
| FLUKA BRAND F CODES | 3-10 |
| HS Code | 29419090 |
| Toxicity | LD50 in mice, rats (mg/kg): 441, 969 s.c. (Welles) |
4-[2,6-diamino-2,3,6-trideoxy-alpha-d-glycopyranosyl]-6-[3-amino-3-deoxy-alpha - Upstream Downstream Industry
| Raw Materials | Ammonium hydroxide Magnesium sulfate anhydrous Ammonium chloride Dextrose Anhydrate Hydrochloric acid Ethyl Alcohol Starch potato |
4-[2,6-diamino-2,3,6-trideoxy-alpha-d-glycopyranosyl]-6-[3-amino-3-deoxy-alpha - Reference
| Reference Show more | 1. [IF=4.616] Zeren Liang et al."Comparative study of serum sample preparation methods in aggregation-based plasmonic sensing."Analyst. 2021 Jan;145(24):7946-7955 |
4-[2,6-diamino-2,3,6-trideoxy-alpha-d-glycopyranosyl]-6-[3-amino-3-deoxy-alpha - Standard
Authoritative Data Verified Data
This product is 03-amino -3-deoxy-a-0-glucopyranosyl-(l-6)-0[2, 6-diamino-2, 3, 6-trideoxy-nuclear-hexopyranosyl-(1-4)]-2-deoxy-d-streptavidin. The titer of tobramycin shall not be less than 900 tobramycin units per 1 mg, calculated as anhydrous.
Last Update：2024-01-02 23:10:35
4-[2,6-diamino-2,3,6-trideoxy-alpha-d-glycopyranosyl]-6-[3-amino-3-deoxy-alpha - Trait
Authoritative Data Verified Data
- This product is white or off-white powder; There is moisture.
- This product is soluble in water, very slightly soluble in ethanol, almost insoluble in ether.
specific rotation
take this product, precision weighing, water dissolution and quantitative dilution of about 40mg per lml solution, according to the law (General 0621), specific rotation of 138 ° to 148 °.
Last Update：2022-01-01 11:58:39
4-[2,6-diamino-2,3,6-trideoxy-alpha-d-glycopyranosyl]-6-[3-amino-3-deoxy-alpha - Differential diagnosis
Authoritative Data Verified Data
- the product and the tobramycin standard were taken, and water was added to prepare a solution containing about 10mg per 1 ml, respectively, as a test solution and a standard solution. The kanamycin control, neomycin and tobramycin standards were separately taken, and water was added to prepare a mixed solution containing about 10mg of each of the above three control or standards per 1 ml. According to the thin layer chromatography (General 0502) test, absorb 2ul of each of the above three solutions, and respectively point on the same silica gel G thin layer plate (activated at 105°C for 2 hours before use), with three gas methane-methanol-concentrated ammonia solution (1:3:2) as the developing solvent, it was developed, dried, sprayed with 1% ninhydrin in water-saturated and normal fermentation solution, and heated at 105 ° C. For 2 minutes. The mixed solution should show three completely separated spots, and 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 standard solution.
- take this product and tobramycin standard, add water to dissolve and quantitatively dilute to make a solution containing about 0.8mg per 1 ml as the test solution and standard solution, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the standard solution according to the chromatographic conditions of the related substances.
- two items (1) and (2) above can be selected as one item.
Last Update：2022-01-01 11:58:40
4-[2,6-diamino-2,3,6-trideoxy-alpha-d-glycopyranosyl]-6-[3-amino-3-deoxy-alpha - Exam
Authoritative Data Verified Data
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 (General rule 0902 first method) colorless; If color, no deeper color shall be compared with the yellow or yellow-green standard colorimetric solution No. 3 (General rule 0901 method 1).
alkalinity
take this product, add water to make a solution containing 0.lg per lml, according to the law (General 0631) , pH value should be 9.0~11.0.
Related substances
take an appropriate amount of this product, add water to dissolve and quantitatively dilute to make a solution containing about 4mg per lml as a sample solution, and take an appropriate amount for precision measurement, solutions containing about 12UG, 24ug and 48ug per 1 ml were prepared by quantitative dilution with water as Control Solutions (1), (2) and (3). According to the determination by high performance liquid chromatography (General rule 0512), silica gel bonded with eighteen alkyl silane is used as filler (pH value is 0.8~8); 0.2mol/L trifluoroacetic acid solution is used as mobile phase; the flow rate was 0.4ml per minute; Detection was performed with an evaporative light scattering detector (reference conditions: drift tube temperature 70-110 ° C., carrier gas flow rate of ml per minute). Weigh appropriate amount of kanamycin B standard and tobramycin standard respectively, add water to dissolve and dilute to make a mixed solution containing 0.25mg kanamycin B and 0.25mg tobramycin in each lml, inject 10u1 into human liquid chromatograph, record chromatogram, the retention time of the tobramycin peak was about 12 minutes, and the resolution between the kanamycin B peak and the tobramycin peak was satisfactory. 10 u1 of control solution (1), (2) and (3) were respectively injected into the liquid chromatograph to record the chromatogram, the linear regression equation is calculated by the logarithmic value of the concentration of the control solution and the logarithmic value of the corresponding peak area, and the correlation coefficient (r) should not be less than 0.99; in addition, l0ul of the sample solution was injected into the human liquid chromatograph, and 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 maximum amount of single impurity shall not exceed 1.0%, and the amount of other single impurities shall not exceed 0.5%, calculated by linear regression equation, the total amount of each impurity shall not exceed 1.5%.
moisture
take this product, according to the moisture determination method (General 0832 first method 1), the water content shall not exceed 8.0%.
ignition residue
take l.Og of this product, check according to law (General rule 0841), not over 0.3%.
bacterial endotoxin
take this product, check according to law (General rule 1143), the amount of endotoxin per 1 mg tobramycin should be less than 2.0EU. (For injection)
Last Update：2022-01-01 11:58:41
4-[2,6-diamino-2,3,6-trideoxy-alpha-d-glycopyranosyl]-6-[3-amino-3-deoxy-alpha - Content determination
Authoritative Data Verified Data
precision weigh the appropriate amount of this product, and add sterilized water to make a solution containing about 1000 units per 1 ml, according to the microbiological assay of antibiotics (General 1201). The confidence limit should not be greater than 7.1000 tobramycin units equivalent to 1 mg of C18H37N509.
Last Update：2022-01-01 11:58:41
4-[2,6-diamino-2,3,6-trideoxy-alpha-d-glycopyranosyl]-6-[3-amino-3-deoxy-alpha - Category
Authoritative Data Verified Data
aminoglycoside antibiotics.
Last Update：2022-01-01 11:58:41
4-[2,6-diamino-2,3,6-trideoxy-alpha-d-glycopyranosyl]-6-[3-amino-3-deoxy-alpha - Storage
Authoritative Data Verified Data
sealed and stored in a dry place.
Last Update：2022-01-01 11:58:42
4-[2,6-diamino-2,3,6-trideoxy-alpha-d-glycopyranosyl]-6-[3-amino-3-deoxy-alpha - Tobramycin Eye Drops
Authoritative Data Verified Data
- This product contains tobramycin (C18H37N509) should be 90.0% to 110.0% of the label children.
- This product can be added with an appropriate amount of preservatives.
trait
This product is colorless to yellowish clear liquid.
identification
- take this product as the test solution; Take an appropriate amount of tobramycin standard and add water to make a solution containing 3mg per 1 ml as the standard solution; Take the test solution and the standard solution, an equal amount was mixed as a mixed solution. According to the thin layer chromatography (General 0502) test, absorb 3 u1 of each of the above three solutions, respectively point on the same silica gel G thin layer plate (activated at 105°C for 2 hours before use), using chloroform-methanol-concentrated ammonia solution (1:3:2) as the developing solvent, expand, dry, spray with 1% ninhydrin water saturated n-butanol solution, heated at 105°C for 2 minutes, the mixed solution should show a single spot, and 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 standard solution or mixed solution.
- take this product and tobramycin standard, add water to dissolve and dilute to make a solution containing about 0.6mg per 1 ml, as the test solution and standard solution, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the standard solution according to the chromatographic conditions of the related substances.
- two items (1) and (2) above can be selected as one item.
examination
- the pH value should be 7.0 to 8.0 (General 0631).
- color this product should be colorless, such as color, and yellow or yellow-green No. 2 Standard Colorimetric liquid (General Principles 0901 The first method) comparison, not deeper.
- Related Substances: take this product as the test solution; Take the standard sample of tobramycin for children, precision weighing, add water to dissolve and quantitatively dilute to prepare a solution containing 3mg per 1 ml, take 4ml and 5ml respectively, put them into 2 measuring flasks respectively, add 0.2% sulfuric acid solution about 0.3mK to adjust the pH value to 7~8), dilute to the scale with water, and shake well, as Control Solutions (1)(60ug/ml,2.0%) and (2)(75ug/ml,2.5%). According to the tobramycin under the chromatographic condition test, take the sample solution, control solution (1) and (2) 10 u1, respectively, injection of human liquid chromatography, record the chromatogram to 2 times the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution (except for the peaks with relative retention time less than 0.7 of the main peak), the maximum single impurity peak area shall not be greater than the main peak area (2.5%) of the control solution (2), and the sum of other impurity peak areas shall not be greater than the main peak area (2.0%) of the control solution (1).
- ethylparaben, propylparaben and benzalkonium chloride are determined by high performance liquid chromatography (General 0512) using, for example, ethylparaben, propylparaben and benzalkonium chloride as preservatives.
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Acetonitrile -5mmol/L ammonium acetate (containing 1% triethylamine, with glacial acetic acid to adjust the pH value to 5.0±0.5) (65:35) as mobile phase; The detection wavelength was 262mn. An appropriate amount of each reference substance of ethylparaben, propylhydroxyphenyl Ester and benzalkonium chloride was taken, dissolved by adding water and diluted to prepare a mixed solution containing 8ug, 8ug and 0.14mg each in 1 ml. Take 20u1 injection liquid chromatograph, record chromatogram, the separation degree between ethylparaben peak, hydroxyphenyl propyl ester peak and benzalkonium chloride peak should meet the requirements, according to benzalkonium chloride peak, tail factor should be less than 1.5.
- determination of this product, according to the content of ethylparaben, hydroxyphenylpropyl ester or benzalkonium chloride in the prescription, quantitatively dilute with water to make a solution containing about 8 μg of ethylparaben or hydroxyphenylpropyl ester or 0.14mg of benzalkonium chloride per 1 ml, and record the chromatogram by injection of 20u1 for precise measurement, hydroxyphenyl propyl ester or benzalkonium chloride standard amount, the same method. The test sample, such as ethylparaben, propylhydroxyphenyl Ester and benzalkonium chloride, shall be 80.0%-120.0% of the labeled amount calculated by peak area according to external standard method.
- The osmolality should be 260 to 0632 mosmol/kg (general).
- other requirements shall be in accordance with the relevant provisions under eye drops (General rule 0105).
Content determination
precision take an appropriate amount of this product, and add sterilized water to make a solution containing about 900 units per 1 ml. According to the method of tobramycin under the determination, obtained.
category
same tobramycin.
specification
(l)5ml:15mg (2)8ml:24mg
storage
It was sealed and kept in a cool and dark place.
Last Update：2022-01-01 11:58:43
4-[2,6-diamino-2,3,6-trideoxy-alpha-d-glycopyranosyl]-6-[3-amino-3-deoxy-alpha - Tobramycin and Dexamethasone Eye Drops
Authoritative Data Verified Data
This product contains tobramycin (C18H37N509) should be 90.0% ~ 110.0% of label amount, containing dexamethasone (C22H29FO5) should be 90.0% ~ 110.0% of label amount.
trait
This product is a white to off-white suspension.
identification
- take 1ml of this product, add sodium sulfate O.lg, fully shake, centrifuge, take the supernatant as the test solution; Take the appropriate amount of tobramycin standard, add water to dissolve and dilute to make a solution containing about 3mg per 1ml, as the standard solution; the sample solution and the standard solution were mixed in equal amounts to form a mixed solution. According to the thin layer chromatography (General 0502) test, draw 3 u1 of each of the above three solutions, and point them respectively on the same silica gel G thin layer plate (activated at 105°C for 2 hours before use), with dichloromethane-methanol-concentrated ammonia solution (1:3:2) as the developing solvent, it was developed, dried, sprayed with 1% ninhydrin in water-saturated n-butanol solution, and heated at 105 ° C. For 2 minutes. The main spot of the mixed solution should show a single spot, and 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 standard solution.
- in the chromatogram recorded under the dexamethasone content determination item, the retention time of the dexamethasone peak in the test solution should be consistent with the retention time of the main peak of the control solution.
examination
- the pH value should be 5.0 to 6.0 (General 0631).
- tobramycin-related substances the product was filtered through a 0.45um microporous membrane filter, and the filtrate was continued as a test solution, add water to dissolve and dilute quantitatively to make a solution containing about 3mg per 1 ml, take 4ml and 5ml precisely, put into 2 200ml measuring flasks respectively, and use 0.0015% sulfuric acid solution (when take 5ml, dilute to the mark with 0.002% sulfuric acid solution> and shake well as control solutions (1)(60ug/ml,2.0%) and (2)(75ug/ml,2.5%). According to the high performance liquid chromatography (General 0512) test, silica gel bonded with eighteen alkyl silane was used as the filler (the pH value was 0.8~8); 0.2mol/L trifluoroacetic acid solution was used as the mobile phase; the flow rate was 0.4ml per minute; Detection was performed with an evaporative light scattering detector (reference conditions: drift tube temperature 70-110°C, carrier gas flow rate 3.0L per minute). Weigh the appropriate amount of kanamycin B standard and tobramycin standard respectively, add water to dissolve and dilute to make a mixed solution containing 0.25mg kanamycin B and 0.25mg tobramycin in each lml, inject 10ul into human liquid chromatograph, record chromatogram, the retention time of the tobramycin peak was about 12 minutes, and the resolution between the kanamycin B peak and the tobramycin peak was satisfactory. The sample solution, control solution (1) and control solution (2) are respectively injected into the liquid chromatograph to record the chromatogram to twice the retention time of the main component peak, if there are impurity peaks in the chromatogram of the test solution (except for the peak with the relative retention time of less than 0.7 of the main peak, if necessary, the auxiliary materials are used for comparison), the maximum single impurity peak area shall not be greater than the main peak area (2.5%) of the control solution (2), and the sum of other impurity peak areas shall not be greater than the main peak area (2.0%) of the control solution (1).
- dexamethasone-related substances take this product, shake well, take a precise amount of 6ml (about 6mg equivalent to dexamethasone), put it in a centrifuge tube, centrifuge it at 5000 rpm for 10 minutes, and pour the supernatant, the precipitate was dissolved by shaking with 5ml of methanol, quantitatively diluted to 10ml with mobile phase, and shaken to obtain a test solution. In addition, appropriate amount of betamethasone reference, precision weighing, dissolving with methanol and quantitatively diluting to make a solution containing about 0.6mg per lml, precision measuring 1ml and placing it in a 100ml bottle, 1ml of the test solution was added precisely, diluted to the scale with the mobile phase, and shaken to serve as a reference solution. Take an appropriate amount of reference solution, quantitatively dilute it with mobile phase to make a solution containing about 0.3ug of dexamethasone per lml, shake well, use it as a sensitive solution, and test according to the chromatographic conditions under the content determination item, the sensitivity solution 20u1 was injected into the liquid chromatograph, and the chromatogram was recorded. The signal-to-noise ratio of dexamethasone peak height should be greater than 10, the chromatogram was recorded to 2.5 times of the retention time of the main component peak. If there are any chromatographic peaks in the chromatogram of the test solution that are consistent with the retention time of the betamethasone peak, the peak area shall be calculated according to the external standard method, and 0.5% of the labeled amount of dexamethasone shall not be exceeded; the Peak area of other individual impurities shall not be greater than that of dexamethasone in the control solution (1.0% ) , and the sum of the peak areas of other impurities shall not be greater than 2 times (2.0%) The Peak area of dexamethasone in the control solution.
- benzalkonium chloride (bromide) if benzalkonium chloride (bromide) is used as a preservative, it is measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Acetonitrile -5mmol/L ammonium acetate (containing 1% triethylamine, with glacial acetic acid to adjust the pH value to 5.0±0.5)(65:35) as mobile phase; The detection wavelength was 262nm. In the chromatogram of the reference solution, the tailing factor should be less than 2.0 according to the ammonium peak of benzalkonium chloride (bromide).
- determination: take this product, shake well, filter through a 0.45um microporous membrane filter, take the filtrate as the test solution, and inject 20u1 into the liquid chromatograph to record the chromatogram, in addition, an appropriate amount of benzalkonium (bromide) Ammonium reference substance was taken, dissolved with water and quantitatively diluted to make about 0.1 mg of the solution, as a control solution, the same method. If the sample contains benzalkonium chloride (bromide), the peak area shall be calculated by external standard method, and the peak area shall be 80.0% ~ 120.0% of the labeled amount.
- osmolality the osmolality shall be 0632-270 m0smol/kg for inspection according to law (General rule 330).
- sterile take this product, add appropriate solvent to dissolve and dilute, after the membrane filtration method, according to the law inspection (General 1101), should comply with the provisions.
- others shall comply with the relevant provisions under Ophthalmic Preparations (General rule 0105).
Content determination
- tobramycin precision take an appropriate amount of this product, and add sterile water to make a solution containing about 1000 units per 1 ml. According to the microbiological assay of antibiotics (General 1201). Confidence limits should not be greater than 7%. 1000 tobramycin units correspond to 1 mg of C18H37N509.
- dexamethasone was measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Acetonitrile-water (28:72) as mobile phase, the detection wavelength was 240nm. 20ul of reference substance solution under dexamethasone related substance was injected into human liquid chromatograph, and the chromatogram was recorded. The order of peaks was betamethasone peak and dexamethasone peak, and the separation degree between betamethasone peak and dexamethasone peak should meet the requirements.
- after fully shaking, measure 2ml, put it in 50ml measuring flask, add 5ml methanol, sonicate dexamethasone, dilute it to scale with mobile phase, and shake well, filter, take the filtrate as the test solution, take 20u1 injection of human liquid chromatograph for precise measurement, record the chromatogram; Take about 25mg of dexamethasone reference substance, weigh it accurately, put it into 25ml measuring flask, add an appropriate amount of methanol to dissolve and dilute to the scale, shake well; Take 2ml with precision, put it in a 50ml measuring flask, dilute to the scale with mobile phase, shake well, and measure with the same method. The content of dexamethasone (C18H37N509) in the sample was calculated by peak area according to external standard method.
category
ophthalmic medication.
specification
5ml: tobramycin 15mg with dexamethasone 5Mg
storage
shade and store in a cool place.
Last Update：2022-01-01 11:58:44
4-[2,6-diamino-2,3,6-trideoxy-alpha-d-glycopyranosyl]-6-[3-amino-3-deoxy-alpha - Tobramycin dexamethasone eye
Authoritative Data Verified Data
This product contains tobramycin (C18H37N509) should be 90.0% ~ 120.0% of label amount; Containing dexamethasone (C22H29F05) should be 90.0% ~ 110.0% of label amount.
trait
This product is a white to yellow ointment.
identification
- take about lg of this product, add 2ml of dichloromethane, shake to dissolve the matrix, add 10% ml of 0.5 sodium sulfate solution, shake vigorously, centrifuge, take appropriate amount of supernatant, A solution containing about 3mg of tobramycin per 1 ml is prepared with water as a test solution; An appropriate amount of tobramycin standard is additionally taken, dissolved with water and diluted to prepare a solution containing about 3mg per 1 ml as a standard solution; the sample solution and the standard solution were mixed in equal amounts to form a mixed solution. According to the thin layer chromatography (General 0502) test, draw 3 u1 of each of the above three solutions, respectively, on the same silica gel G thin layer plate, with two gas methane-methanol-concentrated ammonia solution (1:3:2) as a developing solvent, it was developed, dried, sprayed with 1% ninhydrin-butanol solution, and heated at 105 ° C. For 4 minutes. The mixed solution should show a single spot, and 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 standard solution.
- in the chromatogram recorded under the dexamethasone content determination item, the retention time of the dexamethasone peak in the test solution should be consistent with the retention time of the main peak of the control solution.
examination
- sterile take this product, add sterile decanoate isopropyl Ester dissolved and treated with the appropriate method, the use of membrane filtration method, according to the law (General Principles 1101), should comply with the provisions.
- others shall comply with the relevant provisions under Ophthalmic Preparations (General rule 0105).
Content determination
- tobramycin accurately weigh an appropriate amount of this product (about 1 mg of tobramycin), place it in a separatory funnel, add 50ml of ether, slowly shake to dissolve the matrix, and extract it with water for 5 times, each 15ml, combined extract, 100ml flask. According to the microbiological assay of antibiotics (General 1201). Confidence limits should not be greater than 7%. 1000 tobramycin units correspond to 1 mg of C18H37N509.
- dexamethasone was measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Acetonitrile-water (28:72) as mobile phase, the detection wavelength was 240mn. Take the appropriate amount of dexamethasone and betamethasone, add the appropriate amount of methanol to dissolve, dilute with methanol solution (3-4) to make a solution containing about 0.03mg of each 1 ml, and inject 20u1 into the liquid chromatograph, the chromatogram was recorded, and the order of peaks was betamethasone peak and dexamethasone peak, and the separation degree between betamethasone peak and dexamethasone peak should meet the requirements.
- determination: take an appropriate amount of this product, weigh it accurately (about 3mg of dexamethasone), place it in a separatory funnel, add 50ml of n-hexane, and slowly shake it to dissolve the matrix, extract with methanol solution (3-4) 3 times, each 15ml, combined extract, 50ml flask, diluted with methanol solution (3-4) to the scale, shake, as a test solution. Record chromatogram with 20ul injection liquid chromatograph; Take dexamethasone reference product about 20mg, weigh it accurately, put it in 100ml measuring flask, add methanol solution (3-4), dissolve it and dilute it to scale, shake well, take 15ml accurately, put it in a separatory funnel, add 50ml of n-hexane, extract 2 times with methanol solution (3-4), 15ml each time, combine the extracts, put it in a 50ml measuring flask, dilute with methanol solution (3-4) to the scale, shake, the same method. The content of dexamethasone (C22H29F05) in the sample was calculated by peak area according to external standard method.
category
ophthalmic medication.
specification
3G: tobramycin 9mg with dexamethasone 3Mg
storage
protected from light and stored at 25°C or lower.
Last Update：2022-01-01 11:58:45
4-[2,6-diamino-2,3,6-trideoxy-alpha-d-glycopyranosyl]-6-[3-amino-3-deoxy-alpha - Tobramycin sulfate injection
Authoritative Data Verified Data
This product is a sterile aqueous solution prepared by adding appropriate amount of tobramycin and sulfuric acid. Tobramycin-containing (C18H37N509) shall be between 90.0% and 110.0% of the labeled amount.
trait
This product is colorless to yellowish clear liquid.
identification
- take 1ml of this product, add about 1ml of 0.2% ninhydrin solution, and slowly heat for about 3 minutes with direct fire, which should be purple.
- take this product, according to the tobramycin under the identification of (1) or (2) test, showed the same results.
- identification reaction of sulfate in this product (General rule 0301).
examination
- the pH value should be 4.0 to 6.0 (General 0631).
- color this product should be colorless; If color, and yellow or yellow-green No. 3 Standard Colorimetric liquid (General Principles 0901 The first method), shall not be deeper.
- appropriate amount of related substances of this product shall be taken and quantitatively diluted with labeled amount of water to make a solution containing about 4mg per 1 ml, which shall be used as a test solution and determined according to the method under the item of tobramycin, if there are impurity peaks in the chromatogram of the test solution (except for the peaks with relative retention time less than 0.6 of the main peak), the amount of a single impurity shall not exceed 1.5% of the labeled amount calculated by linear regression equation, the total amount of each impurity shall not exceed 2.0% of the labeled amount.
- the bacterial endotoxin of this product is taken and checked according to law (General rule 1143). The amount of endotoxin contained in 1 mg tobramycin should be less than 2.0EU.
- sterile take this product, diluted with appropriate solvent, treated by membrane filtration method, inspection according to law (General rule 1101), should comply with the provisions.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
precision take the right amount of this product, according to the method of tobramycin under the item, that is obtained.
category
same tobramycin.
specification
(l ) lml:40mg (40,000 units) (2)2ml:80mg (80,000 units)
storage
sealed and kept in a cool dark place.
Last Update：2022-01-01 11:58:46
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Product Name: tobramycin Request for quotation
CAS: 32986-56-4
Tel: 0086-551-65418684
Email: sales@tnjchem.com
info@tnjchem.com
Mobile: 0086 189 4982 3763
QQ: 2881500840
Wechat: 0086 189 4982 3763
WhatsApp: 0086 189 4982 3763
Product List: View Catalog
CAS: 32986-56-4
Tel: 0086-551-65418684
Email: sales@tnjchem.com
info@tnjchem.com
Mobile: 0086 189 4982 3763
QQ: 2881500840
Wechat: 0086 189 4982 3763
WhatsApp: 0086 189 4982 3763
Product List: View Catalog
Multiple SpecificationsSpot supply
Product Name: Tobramycin Visit Supplier Webpage Request for quotationCAS: 32986-56-4
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
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Raw Materials for 4-[2,6-diamino-2,3,6-trideoxy-alpha-d-glycopyranosyl]-6-[3-amino-3-deoxy-alpha