Molecular Formula | C38H72N2O12 |
Molar Mass | 748.98 |
Density | 1.18±0.1 g/cm3(Predicted) |
Melting Point | 113-115°C |
Boling Point | 822.1±65.0 °C(Predicted) |
Specific Rotation(α) | D20 -37° (c = 1 in CHCl3) |
Flash Point | 451°C |
Solubility | Soluble in ethanol (> 30 mg/ml). DMSO(> 30 mg/ml). Methanol |
Vapor Presure | 2.51E-31mmHg at 25°C |
Appearance | White-like to white crystalline powder |
Color | White to Off-White |
pKa | pKa 8.74 (H2O t=25 I=0.167) (Uncertain);9.45(H2O t=25 I=0.167) (Uncertain) |
Storage Condition | Sealed in dry,2-8°C |
Stability | Stable. Incompatible with strong oxidizing agents. |
Refractive Index | 1.536 |
MDL | MFCD00873574 |
Physical and Chemical Properties | Melting point 113-115°C |
Use | [Use] for respiratory tract infections, urinary tract infections, skin and soft tissue infections and sexually transmitted diseases |
Risk Codes | 42/43 - May cause sensitization by inhalation and skin contact. |
Safety Description | S22 - Do not breathe dust. S36/37 - Wear suitable protective clothing and gloves. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) |
WGK Germany | 2 |
RTECS | RN6960000 |
HS Code | 29419090 |
Toxicity | LD50 oral in rat: > 2gm/kg |
Reference Show more | 1. Dong Jing, Zhang Lushan, Liu Shaochun, Zhang Guodong, Zhou Shun, Yang Qiuhong, AI Xiaohui. Isolation, identification and drug sensitivity analysis of a Klebsiella Pneumonia isolated from Procambarus clarkii [J]. Journal of Huazhong Agricultural University, 2021,40(01):93-98 2. Chen Shu-Xin, Wang Jing, He Shi-Chong, Liu Yan-Zheng, Feng Huajun, Mu Peng-Qian. Determination of 17 antibiotics in water by ultra performance liquid chromatography-tandem mass spectrometry [J]. China Environmental Monitoring, 2020,36(06):119-126. 3. Jiang, Fa-Xing, et al. "Antimicrobial operability of Neisseria gonorhoeae isolates from Hefei (2014-2015): genetic characteristics of antibiological resistance." BMC infectious diseases 17.1 (2017): 1-6.https:// doi.org/10.1186/s12879-017-2472-z 4. Wang, Jinli, et al. "In vitro synergistic effect of baicalin." Poultry science 98.1 (2019): 373-380.https://doi.org/10.3382/ps/pey356 5. Chunxi Zhao, Yang Jiao, Zhe Gao, Yaling Yang, Hong Li, N, S co-doped carbon dots for temperature probe and the detection of tetracycline based on the inner filter effect, Journal of Photochemistry and Photobiology A: Chemistry, Volume 367, 2018, Pages 137- 6. [IF=3.09] Jiang Fa-Xing et al."Antimicrobial susceptibility of Neisseria gonorrhoeae isolates from Hefei (2014-2015): genetic characteristics of antimicrobial resistance."Bmc Infect Dis. 2017 Dec;17(1):1-6 7. [IF=6.057] Ruirui Xie et al."Lanthanide-functionalized metal-organic frameworks based ratiometric fluorescent sensor array for identification and determination of antibiotics."Talanta. 2021 Aug;231:122366 8. [IF=3.352] Jinli Wang et al."In vitro synergistic effect of baicalin with azithromycin against Staphylococcus saprophyticus isolated from francolins with ophthalmia."Poultry Sci. 2019 Jan;98:373 9. [IF=2.986] Cheng Hao et al."Electrospun Nanofibers with High Specific Surface Area to Prepare Modified Electrodes for Electrochemiluminescence Detection of Azithromycin."J Nanomater. 2021;2021:9961663 |
white crystals. The melting point was 113-115 °c.
The titer per Img shall not be less than 945 azithromycin units calculated as anhydrous; The crystallinity shall be in accordance with the regulations, and the pH value shall be 9.o ~ 11.o (lOOmg of the product is dissolved in 25 mL methanol); the relevant substances shall be in accordance with the regulations, and the water content shall not exceed 5.0%; Ignition residue
Not over 0. 0025%; Containing heavy metals not over 0.
This product is (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2, 6-dideoxy-3-0 methyl -3-0 methyl-a-L-core-hexopyranosyl) oxy] -2-ethyl-3, 4, 10-trihydroxy-3, 5,6,8,10,12,14-heptamethyl-11-[[3,4, 6-trideoxy-3-(dimethylamino)]-B-D-xylo-hexopyranosyl] oxy] -1-oxa-6-azacyclo15-15-one. The content shall be 96.0% to 102.0% calculated as anhydrous.
take this product, precision weighing, plus anhydrous ethanol dissolution and quantitative dilution of about 20mg per lml solution, according to the law (General 0621), the specific rotation should be from one 45 ° to one 49 °.
with erythromycin A as raw material, after oximation, rearrangement under the action of hydrochloric acid, dehydration, reduction and methylation, azithromycin can be obtained.
developed by Pfizer Inc., USA, launched in 1988. Macrolide antibiotics, the antibacterial mechanism is similar to erythromycin, but the antibacterial spectrum is wider; The antibacterial activity of gram-positive bacteria is stronger, and the Gram-negative bacteria such as Haemophilus influenzae, salmonella, Escherichia coli, the antibacterial activity of Shigella was also strong. It has a good therapeutic effect on respiratory tract infection, skin and soft tissue infection and diseases caused by sensitive strains.
take this product, water dispersion, inspection according to law (General 0981), should comply with the provisions.
take about O.lg of this product, add methanol 25ml, shake to dissolve, add water 25ml, shake, according to the law (General 0631),pH value should be 9.0~11.0.
The use of new or low-temperature injector. Weigh the appropriate amount of this product accurately, add diluted solution [ammonium dihydrogen phosphate solution (weigh ammonium dihydrogen phosphate 1.73g, dissolve and dilute to 1000ml with water, adjust the pH value to 10.0±0.05 with ammonia test solution)-Methanol-acetonitrile (7:7:6)] Dissolved and quantitatively diluted to prepare a solution containing about 10 mg per 1ml as a test solution, in a 200ml measuring flask, dilute to the scale with the above diluent, and shake to serve as a control solution. According to the determination of high performance liquid chromatography (General 0512), silica gel bonded with eighteen alkyl silane was used as the filler; Mobile phase A was phosphate buffer (0.05mol/L dipotassium hydrogen phosphate solution was taken, adjust the pH value to 20% with 8.2 phosphoric acid solution-acetonitrile (45:55), mobile phase B is methanol, column temperature is 30 ° C. (if necessary, adjust appropriately); the linear gradient elution was carried out as follows; The flow rate was 1.0 per minute and the detection wavelength was 210mn. Take appropriate amounts of the reference substance of impurity S and impurity A, and add the above diluent to dissolve and dilute to prepare A solution containing about 0.05mg each in 1ml as the reference substance solution of impurity S and impurity A; an appropriate amount of azithromycin system suitability control (including Impurity R, impurity Q, impurity J, impurity I, impurity H, azithromycin and impurity B) shall be taken, add the above reference solution to dissolve and dilute to make a solution containing about 10 mg per 1ml as the system applicable solution; Take 10ml of the control solution for precise measurement, put it in a 50ml measuring flask, and dilute it to the scale with diluent, shake, as a sensitivity solution, take the system applicability solution and the sensitivity solution 50 u1, respectively, the injection of human liquid chromatography, the sensitivity of the solution of the main component peak high signal to noise ratio should be greater than 10, the resolution of each peak in the system applicable solution chromatogram should be greater than 1.2, and the retention time of azithromycin peak should be between 30 and 40 minutes. The sample solution and the control solution are respectively injected into the liquid chromatograph to record the chromatogram. If there are impurity peaks in the chromatogram of the test solution, the peak area of impurity B shall not be more than 2 times (1.0%) of the main peak area of the control solution, and the impurity R, impurity Q, impurity J, impurity I, impurity S, impurity A, and impurity H are calculated as the corrected peak area (multiplied by the correction factor of 0.5, 0.4, 0.7, 1.6, 0.4, 1.4, 0.1, respectively) all shall not be greater than the main peak area of the control solution (0.5% ) , and the peak area of other individual impurities shall not be greater than the main peak area of the control solution (0.5% ) , the sum of the peak areas of each impurity shall not be greater than 4 times (2.0%) of the main peak area of the control solution (for injection) based on the corrected peak area. If there are impurity peaks in the chromatogram of the test solution, the peak area of impurity B shall not be more than 4 times (2.0%) of the main peak area of the control solution, and the impurity R, impurity Q, impurity J, impurity I, impurity S, impurity A, and impurity H are calculated as the corrected peak area (multiplied by the correction factor of 0.5, 0.4, 0.7, 1.6, 0.4, 1.4, 0.1, respectively) all shall not be greater than 2 times (1.0%) the main peak area of the control solution, and the peak area of other individual impurities shall not be greater than 2 times (1.0%) the main peak area of the control solution, the sum of the peak areas of each impurity shall not be greater than 8 times (4.0%) the area of the main peak of the control solution (for oral use) based on the corrected peak area. The peaks in the chromatogram of the test solution which are smaller than the main peak area of the sensitivity solution are ignored.
take this product, according to the determination of moisture (General 0832 first method 1), the water content shall not exceed 5.0%.
take l.Og of this product and determine it according to law (General rule 0841). The remaining residue shall not exceed 0.2%.
The residue left in the item of burning residues shall be inspected according to law (General Principles 0821, Law 2) and shall not contain more than 10 ppm of heavy metals (for injection), not more than 25 parts per million (for oral use).
measured by high performance liquid chromatography (General 0512).
silica gel bonded with eighteen alkyl silane as filler; Phosphate buffer (0.05mol/L dipotassium hydrogen phosphate solution, adjusted to pH 20% with 8.2 phosphoric acid solution)-acetonitrile (45:55) mobile phase; The detection wavelength was 210mn. Take the appropriate amount of azithromycin system applicable reference substance, add acetonitrile to dissolve and dilute the solution containing 10 mg per 1 ml, take 50u1 injection liquid chromatograph, and record the chromatogram should be consistent with the standard spectrum.
take an appropriate amount of this product, weigh it accurately, add acetonitrile to dissolve and quantitatively dilute to prepare a solution containing about 1 mg per 1 ml as a test solution, A 50ul injection liquid chromatograph was used to record the chromatogram. An appropriate amount of azithromycin reference substance was taken and determined by the same method. According to the external standard method to calculate the peak area, that is.
macrolide antibiotics.
sealed and stored in a cool and dry place.
This product contains azithromycin (C38H72N2012) should be labeled the amount of 90.0% to 110.0%.
This product is granular or powder; Aromatic.
take an appropriate amount of the fine powder of this product, and add ethanol to make a solution containing 5mg of azithromycin per lml, filter, and take the filtrate as the test solution; According to the identification under azithromycin (1) or (2) trials showing the same results.
take the contents under the item of difference in loading amount, mix evenly, weigh the appropriate amount accurately (about 0.lg equivalent to azithromycin), acetonitrile was added to dissolve and quantitatively dilute to prepare a solution containing about 1 mg of azithromycin per 1 ml, filtered, and the filtrate was taken as a test solution, which was obtained by measuring according to the method under the item of azithromycin.
Same as azithromycin.
0.lg
sealed and stored in a dry place.
This product contains azithromycin (C38H72N2012) should be labeled the amount of 90.0% to 110.0%.
This product is a white tablet or film-coated tablet, white or white after removing the coating.
take the appropriate amount of fine powder of this product, and make a solution containing 5mg of azithromycin per 1 ml by adding fermentation, filter, and take the filtrate as the test solution. Or (2) trials showing the same results.
Take 10 tablets of this product, precision weighing, fine grinding, precision weighing appropriate amount (about equivalent to 0.lg of azithromycin), acetonitrile was added to dissolve and quantitatively dilute to prepare a solution containing about 1 mg of azithromycin per 1 ml, filtered, and the filtrate was taken as a test solution, which was obtained by measuring according to the method under the item of azithromycin.
Same as azithromycin.
(1)0.lg (2)0.125g (3)0.25g (4)0.5g
sealed and stored in a dry place.
This product contains azithromycin (C38H72N2012) should be labeled the amount of 90.0% to 110.0%.
take an appropriate amount of the contents of this product, add ethanol to make a solution containing 5mg of azithromycin per 1 ml, filter, and take the continued filtrate as the test solution. The same results were shown for the identification (1) or (2) tests under azithromycin.
take the contents under the item of difference in loading quantity, mix evenly, weigh accurately, grind finely, weigh accurately and take appropriate amount (about equivalent to azithromycin O.lg), add acetonitrile quantitative dilution to prepare a solution containing 1 mg of azithromycin per 1 ml, filter, take the filtrate as a test solution, according to the method under the item of azithromycin, then get.
Same as azithromycin.
(1)0.125g (2) 0.25g
sealed and stored in a cool and dry place.
This product contains azithromycin (C38H72N2012) should be labeled the amount of 90.0% to 110.0%.
This product is suspended particles.
take an appropriate amount of the fine powder of this product, add ethanol to make a solution containing 5mg of azithromycin per lml, filter, take the filtrate as the test solution, according to the identification under azithromycin (1) or (2) trials showing the same results.
take the contents under the item of difference in loading amount, mix evenly, weigh the appropriate amount accurately (about 0.lg equivalent to azithromycin), acetonitrile was added to dissolve and quantitatively dilute to prepare a solution containing about 1 mg of azithromycin per 1 ml, filtered, and the filtrate was taken as a test solution, which was obtained by measuring according to the method under the item of azithromycin.
Same as azithromycin.
(1)0.lg (2)0.125g (3)0.25g (4)0.5g
sealed and stored in a dry place.
This product is a sterile preparation made of azithromycin with appropriate amount of citric acid or other suitable cosolvent. Azithromycin (C38H72N2012) should be included in 93.0%-107.0% of label load based on average loading.
This product is white or off-white loose block or powder.
take an appropriate amount of this product, add an appropriate amount of water (50mg of azithromycin and 1 ml of water) to dissolve, and dilute with ethanol to prepare a solution containing about 5mg of azithromycin per 1 ml as a test solution. The same results were shown for the identification (1) or (2) test under azithromycin.
take the content under the difference of loading amount (about equivalent to 0.lg of azithromycin), weigh precisely, add appropriate amount of water (50mg of azithromycin and 1 ml of water) to dissolve, A solution containing about 1 mg of azithromycin per 1 ml was prepared by quantitative dilution with the diluent under the item of related substances, and as a test solution, it was obtained by measuring according to the method under the item of azithromycin.
Same as azithromycin.
calculated as C38H72N2012 (1)0.lg (2)0.125g(3)0.25g (4)0.5g
sealed and stored in a cool place.