sulfamethoxazole - Names and Identifiers
sulfamethoxazole - Physico-chemical Properties
Molecular Formula | C10H11N3O3S
|
Molar Mass | 253.28 |
Density | 1.3915 (rough estimate) |
Melting Point | 166 °C |
Boling Point | 482℃ |
Flash Point | >110°(230°F) |
Water Solubility | Soluble in ethanol or acetone. Very slightly soluble in water |
Solubility | Very slightly soluble in water, easily soluble in dilute acid, dilute lye or ammonia. |
Appearance | Crystal or white powder |
Color | White to Pale Yellow |
Merck | 14,8918 |
BRN | 6732984 |
pKa | pKa 5.60±0.05 (Uncertain) |
Storage Condition | Keep in dark place,Inert atmosphere,Room temperature |
Stability | Stable, but light sensitive. Incompatible with strong oxidizing agents. |
Sensitive | Light Sensitive |
Refractive Index | 1.6630 (estimate) |
MDL | MFCD00010546 |
Physical and Chemical Properties | White crystalline powder, odorless, slightly bitter taste. Melting point 168 °c. Very slightly soluble in water, soluble in dilute acid, dilute alkali or ammonia. |
Use | Sulfa drugs, mainly used for the treatment of acute and chronic urinary tract infection, can also be used for the Prevention of meningitis and influenza caused by acute otitis media |
sulfamethoxazole - Risk and Safety
Risk Codes | R36/37/38 - Irritating to eyes, respiratory system and skin.
R43 - May cause sensitization by skin contact
R22 - Harmful if swallowed
|
Safety Description | S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
S36 - Wear suitable protective clothing.
S36/37/39 - Wear suitable protective clothing, gloves and eye/face protection.
S22 - Do not breathe dust.
|
WGK Germany | 2 |
RTECS | WP0700000 |
TSCA | Yes |
HS Code | 29350090 |
Hazard Class | IRRITANT |
Toxicity | LD50 orally in mice: 3662 mg/kg (Yamamoto) |
sulfamethoxazole - Upstream Downstream Industry
sulfamethoxazole - Reference
Reference Show more | 1. Chi Xiang, Zhou Wenbing, Wu Lin, etc. Oxidation removal of three tetracyclines and three sulfonamides from biogas slurry by Fenton process [J]. Journal of Agricultural Environment Science, 2018, 37(11):100-104. 2. Chi Xiang, Jin Yue, Zhou Wenbing, et al. Oxidation removal of three tetracyclines and three sulfonamides from biogas slurry by ultrasound-Fenton process [J]. Journal of Environmental Sciences, 2019(7). 3. Liu Minfang, Cao mengrui, Li Rongxu, etc. Isolation, identification and drug sensitivity analysis of salmonella from waterfowl in some areas of Guangdong province [J]. Heilongjiang Journal of Animal Science and Veterinary Medicine, 2018(10). 4. Kollinger, Kefei, niudejun, et al. Screening of sulfonamide sensitive strains by UV mutagenesis and its application in the detection of milk sulfonamide antibiotics [J]. Modern food science and technology, 2019, 35(5):296-303. 5. Ning Yu, Chen Yu, Yan Zhiming. Sulfonamides in milk based on SNW-1 magnetic solid phase extraction [J]. Fujian Journal of Agricultural Sciences, 2020,35(10):1154-1161. 6. Jin Yue, Zhou Wenbing, Xiao Naidong, Cai Jianbo, Cai Huan, Wang shuofeng. Removal of three sulfonamide antibiotics from pig farm biogas slurry by BiFeO_3/H_2O_2 Fenton-like system [J]. Journal of Agricultural Resources and Environment, 2020,37(06):945-950. 7. Kaihui Zhang, Meiqi Wang, Yufeng Yao, Tao Huang, Fangle Liu, Chenchen Zhu, Chaozhan Lin, Pharmacokinetic study of seven bioactive components of Xiaoyan Lidan Formula in cholestatic and control rats using UPLC-MS/MS, Biomedicine & Pharmacotherapy, Volume 13 8. Wang, Hl., Si, Xj., Wu Th. et al. New Enhanced Method for Determination of Trace Sulfamethodxazole Based on the Fluorescence Behaviors of Cyclodextrins in Water Solutions. J Fluoresc 30, 1105-1112 (2020). https://doi.org/10.1007/s10895-020-02582-3 9. Zhang, Yuanyuan, et al. "Degradation of sulfamethoxazole by UV/persulfate in different water samples: influential factors, transformation products and toxicity." Chemical Engineering Journal 379 (2020): 122354.https://doi.org/10.1016/j.cej.2019.122354 10. Shao, Yifei, et al. "Co-sorption of sulfamethoxazole and Cu onto several soils with different properties and their binding mechanism." IOP Conference Series: Earth and Environmental Science. Vol. 432. No. 1. IOP Publishing, 2020. 11. Zhang X, Han L, Liu J et al. Pharmacokinetic Study of 7 Compounds Following Oral Administration of Fructus Aurantii to Depressive Rats. Frontiers in Pharmacology. 2018 ;9:131. DOI: 10.3389/fphar.2018.00131. PMID: 29556193; PMCID: PMC5845165. 12. [IF=5.81] Zhang Xianhua et al."Pharmacokinetic Study of 7 Compounds Following Oral Administration of Fructus Aurantii to Depressive Rats."Front Pharmacol. 2018 Mar;0:131 13. [IF=4.223] Rong Chuan et al."Formation of disinfection byproducts from sulfamethoxazole during sodium hypochlorite disinfection of marine culture water."Environ Sci Pollut R. 2018 Nov;25(33):33196-33206 14. [IF=19.503] Cheng-Xin Chen et al."Non-covalent self-assembly synthesis of AQ2S@rGO nanocomposite for the degradation of sulfadiazine under solar irradiation: The indispensable effect of chloride."Appl Catal B- Environ. 2021 Dec;298:120495 15. [IF=13.273] Yuanyuan Zhang et al."Degradation of sulfamethoxazole by UV/persulfate in different water samples: Influential factors, transformation products and toxicity."Chem Eng J. 2020 Jan;379:122354 16. [IF=6.529] Kaihui Zhang et al."Pharmacokinetic study of seven bioactive components of Xiaoyan Lidan Formula in cholestatic and control rats using UPLC-MS/MS."Biomed Pharmacother. 2021 Jul;139:111523 17. [IF=4.223] Zhang Yuanyuan et al."Toxicity of disinfection byproducts formed during the chlorination of sulfamethoxazole, norfloxacin, and 17β-estradiol in the presence of bromide."Environ Sci Pollut R. 2021 Sep;28(36):50718-50730 18. [IF=2.217] Wang Hong-ling et al."New Enhanced Method for Determination of Trace Sulfamethodxazole Based on the Fluorescence Behaviors of Cyclodextrins in Water Solutions."J Fluoresc. 2020 Sep;30(5):1105-1112 19. [IF=6.498] Jingyun Shi et al."Groundwater antibiotics and microplastics in a drinking-water source area, northern China: Occurrence, spatial distribution, risk assessment, and correlation."Environ Res. 2022 Jul;210:112855 20. [IF=4.821] Jin-Ye Lang et al."Preparation of boronate-modified larger mesoporous polymer microspheres with fumed silica nanoparticle and toluene as synergistic porogen for selective separation of sulfonamides."Microchem J. 2022 Apr;175:107193 21. [IF=6.707] Nan Zhang et al."Growth of MOF@COF on corncob as effective adsorbent for enhancing adsorption of sulfonamides and its mechanism."Appl Surf Sci. 2022 Apr;580:152285 22. [IF=7.963] Han Wang et al."A contrasting alteration of sulfamethoxazole bioaccessibility in two different soils amended with polyethylene microplastic: In-situ measurement using diffusive gradients in thin films."Sci Total Environ. 2022 Feb;808:152187 23. [IF=4.759] Ji-Cheng Sun et al."Metal-organic framework modified carbon cloth for electric field enhanced thin film microextraction of sulfonamides in animal-derived food."JOURNAL OF CHROMATOGRAPHY A. 2022 May;:463120 24. [IF=5.833] Hu Wenyao et al."Flexible membrane composite based on sepiolite/chitosan/(silver nanoparticles) for enrichment and surface-enhanced Raman scattering determination of sulfamethoxazole in animal-derived food."MICROCHIMICA ACTA. 2022 May;189(5):1-12 |
sulfamethoxazole - Nature
Open Data Verified Data
white crystalline powder, odorless, slightly bitter taste. Melting point 168 °c. Very slightly soluble in water, soluble in dilute acid, dilute alkali or ammonia.
Last Update:2024-01-02 23:10:35
sulfamethoxazole - Preparation Method
Open Data Verified Data
3-amino -5-methyl isoxazole was obtained by esterification of oxalic acid with ethanol, condensation with acetone and sodium methoxide, cyclization and amination, it was then condensed with acetaminophen sulfonyl chloride and purified by hydrolysis.
Last Update:2022-01-01 10:10:57
sulfamethoxazole - Introduction
This product is a medium-acting sulfa drug with broad-spectrum antibacterial effect. For non-enzymatic Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumoniae, Escherichia coli, Klebsiella, Salmonella, Shigella and other Enterobacteriaceae Some strains, Neisseria gonorrhoeae, Meningococcus, Haemophilus influenzae have antibacterial effects. In addition, it also has antibacterial activities against Chlamydia trachomatis, Streptococcus pneumoniae, Klebsiella, Salmonella, Shigella. Plasmodium falciparum and Toxoplasma gondii in vitro. However, in recent years, the resistance of bacteria to this product has increased significantly, especially Streptococcus, Neisseria and Enterobacteriaceae. Sulfonamides are broad-spectrum bacteriostatic agents, similar in structure to p-aminobenzoic acid (PABA), which can compete with PABA to act on the dihydrofolate synthase in bacteria, thereby preventing PABA from being used as a raw material to synthesize folic acid required by bacteria, reducing The amount of tetrahydrofolic acid with metabolic activity, and the latter is an essential substance for bacteria to synthesize purine, thymine nucleoside and deoxyribonucleic acid (DNA), thus inhibiting the growth and reproduction of bacteria.
Last Update:2022-10-16 17:28:11
sulfamethoxazole - Use
Open Data Verified Data
The antibacterial spectrum is broad, the antibacterial effect is strong, and it is particularly effective against Staphylococcus and Escherichia coli. Suitable for respiratory system, urinary system and intestinal infections. Can hinder the growth of bacteria, the role of Staphylococcus and Escherichia coli is particularly strong. Mainly used for the treatment of fowl cholera.
Last Update:2022-01-01 10:10:57
sulfamethoxazole - Compound sulfamethoxazole oral suspension
Authoritative Data Verified Data
This product contains sulfamethoxazole (C10H11N3O3S) and trimethoprim (C14H18N403) should be labeled with the amount of 90.0% ~ 110.0%.
prescription
prescription 1 prescription 2
Sulfamethoxazole 80g 40g
Trimethoprim 16g 8g
Appropriate amount of excipients
Made up to 1000ml 1000ml
trait
This product is light yellow viscous suspension; Sweet, slightly bitter.
identification
- take an appropriate amount of this product (about 50mg equivalent to trimethoprim), add 10ml of dilute sulfuric acid, shake to dissolve trimethoprim, filter, add 0.5ml of Iodine test solution to the filtrate, and produce brown precipitate.
- in the chromatogram recorded under the content determination item, the retention time of the two main peaks of the test solution should be consistent with the retention time of the corresponding two main peaks of the control solution.
- take an appropriate amount of this product (about 50mg equivalent to sulfamethoxazole) to show the identification reaction of the first aromatic amine (General rule 0301).
examination
- the pH value should be 4.0 to 6.0 (General 0631).
- others should comply with the relevant provisions under oral suspension (General rule 0123).
Content determination
- 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-triethylamine (200:799:1)(With sodium hydroxide solution or glacial acetic acid to adjust the pH value to 5.9) as mobile phase; The detection wavelength was 240nm. The number of theoretical plates shall not be less than 4000 calculated by sulfamethoxazole peak; The separation degree of sulfamethoxazole peak and trimethoprim peak shall meet the requirements.
- determination of this product, shake, take 5ml with a volume pipette, put it in a 100ml measuring flask, wash the inner wall of the pipette with methanol, wash the liquid and the flask, add an appropriate amount of methanol, shake to dissolve the two principal components and dilute to the scale, shake well, filter, take 2ml of continuous filtrate accurately, put it in 50ml (prescription 1) or 25ml (prescription 2) measuring flask, dilute to scale with mobile phase, shake well, as a test solution, take 20 u1 with precision, inject into liquid chromatograph, record chromatogram; Take appropriate amount of sulfamethoxazole and trimethoprim respectively, precision weighing, adding an appropriate amount of methanol to dissolve, and quantitatively diluting with mobile phase to prepare a mixed solution containing 0.16mg of sulfamethoxazole and 32# trimethoprim per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.
category
sulfonamides.
specification
100ml
storage
light shielding, sealed storage.
Last Update:2022-01-01 13:43:54
sulfamethoxazole - Compound sulfamethoxazole tablets
Authoritative Data Verified Data
This product contains sulfamethoxazole (C10H11N3O3S) and trimethoprim (C14H18N403) should be labeled with the amount of 90.0% ~ 110.0%.
prescription
sulfamethoxazole 400g
Trimethoprim 80g
Appropriate amount of excipients
Made into 1000 tablets
trait
This product is white tablet.
identification
- take an appropriate amount of fine powder of this product (about 50mg of trimethoprim), add 10ml of dilute sulfuric acid, heat to dissolve trimethoprim, cool, filter, add 0.5ml of Iodine test solution to the filtrate, the formation of brown precipitate.
- take an appropriate amount of fine powder of this product (equivalent to 0.2g of sulfamethoxazole), add 10ml of methanol, shake, filter, and take the filtrate as the test solution; in addition, 0.2g of sulfamethoxazole control substance and 40mg of trimethoprim control substance were dissolved in 10ml of methanol and used as a control solution. According to the thin layer chromatography (General 0502) test, absorb the above two solutions each 5 u1, respectively, on the same silica gel GF254 thin layer plate, with chloroform-methanol-N,N-dimethylformamide (20:2:1) was used as a developing solvent, which was developed, dried, and examined under a UV lamp (254nm). The position and color of the main spot of the two components shown in the test solution should be the same as the main spot of the control solution.
- in the chromatogram recorded under the content determination item, the retention time of the two main peaks of the test solution should be consistent with the retention time of the corresponding two main peaks of the control solution.
- take an appropriate amount of fine powder of this product (about 50mg equivalent to sulfamethoxazole) to show the identification reaction of the first aromatic amine (General rule 0301).
- two items (2) and (3) above can be selected as one item.
examination
- dissolution of this product, according to the dissolution and release determination method (General 0931 second method), with 0.900ml of lmol/L hydrochloric acid solution is the dissolution medium, and the rotation speed is 75 rpm, which is operated according to law. After 30 minutes, take the appropriate amount of the solution, filter it, and take 10ul of the continued filtrate with precision, the dissolution amount of sulfamethoxazole and trimethoprim in each tablet was calculated according to the method under the content determination item. The limit shall be 70% of the labeled amount and shall be in accordance with the regulations.
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
- 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-triethylamine (200:799:1)(With sodium hydroxide solution or glacial acetic acid to adjust the pH value to 5.9) as mobile phase; The detection wavelength was 240nm. The number of theoretical plates shall not be less than 4000 calculated by trimethoprim peak, and the separation degree between sulfamethoxazole peak and trimethoprim peak shall meet the requirements.
- determination of 10 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (equivalent to 44mg of sulfamethoxazole), put in a 100ml measuring flask, add 0.1 mol/L hydrochloric acid solution appropriate amount, ultrasonic to dissolve the two main components, with O. Dilute the lmol/L hydrochloric acid solution to the scale, shake well, filter, take the filtrate as the test solution, take the l0ul with precision, inject into the liquid chromatograph, record the chromatogram; additional sulfamethoxazole control and trimethoprim control in appropriate amounts, precision weighing, plus O. 1 mol/L hydrochloric acid solution was dissolved and quantitatively diluted to prepare a solution containing 0.44mg sulfamethoxazole and trimethoprim 89 @ per 1 ml. The solution was shaken and determined by the same method. According to the external standard method to calculate the peak area, that is.
category
sulfonamides.
storage
light shielding, sealed storage.
Last Update:2022-01-01 13:43:55
sulfamethoxazole - Compound sulfamethoxazole injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of sulfamethoxazole and trimethoprim. The contents of sulfamethoxazole (Cl0H11N303S) and trimethoprim (C14H18N403) shall be 90.0% to 110.0% of the labeled amount.
prescription
sulfamethoxazole 200g
Trimethoprim 40g
Appropriate amount of water for injection
Made up to 1000ml
trait
This product is colorless to yellowish clear liquid.
identification
- take 0.5 of this product, add O.lmol/L sodium hydroxide solution (ImU), add several drops of cupric acid solution, which will result in grass green precipitation.
- take 0.5ml of this product, add 1 ml of ammonia test solution, 5ml of water and 10ml of chloroform, shake extraction, take 2ml of chloroform layer, add appropriate amount of nitric acid solution (1-2), gently shake, the upper layer showed red, then turned yellow-brown.
- in the chromatogram recorded under the content determination item, the retention time of the two main peaks of the test solution should be consistent with the retention time of the corresponding two main peaks of the control solution.
- This product shows the identification reaction of aromatic first amines (General rule 0301).
examination
- the pH value should be 9.0 to 10.5 (General OMI).
- sulfanilamide and sulfanilic acid precision take this product lml (equivalent to sulfamethoxazole 0.2g), put in a 20ml measuring flask, add 1% ammonia anhydrous ethanol-methanol mixed solution (95:5) dilute to the scale, shake, as a test solution; Take an appropriate amount of sulfamethoxazole reference, sulfamethoxazole reference and sulfanilic acid reference, precision weighing, add 1% ammonia in ethanol-methanol mixed solution (95:5) dissolved and diluted separately to make the sulfamethoxazole lOmg, sulfamethoxazole 0.05mg and sulfanilic acid 0.03mg solution per 1 ml, as Control Solutions (1), (2) and (3). According to the thin layer chromatography (General 0502) test, absorb the above four solutions of 10 u1, respectively, on the same silica gel GF254 thin layer plate, using anhydrous ethanol-methanol-n-heptane-chloroform-glacial acetic acid (28.5:1.5:30:30:10) as the developing solvent, after spreading, air-dry, put under UV light (254nm) for inspection, after spraying with a p-dimethylaminobenzaldehyde solution (0.1% of an ethanol solution containing of p-dimethylaminobenzaldehyde and 1 ml of hydrochloric acid), the color was immediately examined. If the test solution shows the impurity spots corresponding to the sulfanilamide control and the sulfanilic acid control, the color thereof shall not be deeper compared with the main spots of the control solution (2) and (3). Trimethoprim degradation products: Take 1 ml of this product (equivalent to 40mg of trimethoprim), put it in a 50ml centrifuge tube, add 15ml of 0.06mol/L hydrochloric acid solution, shake well, add 15ml of trimethyl methane, shake for 30 seconds, high speed centrifugation for 3 minutes. The transferred aqueous layer was placed in a 125ml separating funnel, and the trimethyl methane layer was extracted with 15ml of 0.06mol/L hydrochloric acid solution, and the aqueous layer was combined. Add 2ml of 10% sodium hydroxide solution, extract 3 times with 20ml of trichloromethane respectively, combine the three-gas methane layer, blow dry with nitrogen, and add 1 ml of human trichloromethane-methanol (1:1) to the residue to dissolve, as a test solution; Another appropriate amount of trimethoprim reference substance, precision weighing, plus three gas methane-methanol (1:1) dissolved and diluted to make each 1 ml containing 40mg and 0.2mg of solution, as Control Solutions (1) and (2). According to the thin layer chromatography (General 0502) test, absorb the above three solutions of 10 u1, respectively, on the same silica gel GF254 thin layer plate, with chloroform-methanol-concentrated ammonia solution (97:7.5:1) for the development of the agent, after spreading, dry, first set the UV lamp (254mn) under the inspection, then spray with 10% ferric chloride -5% potassium ferricyanide mixed solution (1:1) (Mixing before use) check immediately after color Development. The specific shift value of trimethoprim main spot is about 0.5, if the test solution shows impurity spots within 0.6~0.7 of the specific shift value, its color shall not be deeper (0.5%) than that of the trimethoprim main spot of the reference solution (2).
- bacterial endotoxin this product, according to the law inspection (General 1143), each 1 mg of sulfamethoxazole containing endotoxin amount should be less than 0.10EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test with eighteen alkyl silane bonded silica gel as filler; Acetonitrile-triethylamine-water (200:1 : 799 )[with acetic acid solution (1 -100) adjust the pH value to 5.9±0.1] as the mobile phase; The detection wavelength was 254mn. The resolution between trimethoprim peak and sulfamethoxazole peak should be greater than 5.0, and the tailing factor of trimethoprim peak and sulfamethoxazole peak should not exceed 2.0.
- determination precision measure lml of this product (about 0.2g equivalent to sulfamethoxazole), put it in a 50ml measuring flask, dilute to the scale with methanol, shake well, take lml with precision, in a 25ml measuring flask, dilute to the scale with mobile phase, shake well, and use as the test solution. Weigh the appropriate amount of sulfamethoxazole and trimethoprim respectively, A solution containing about 0.16mg of sulfamethoxazole and 0.032mg of trimethoprim per 1 ml was prepared by dissolving and diluting with methanol as a control solution. The above two kinds of solutions are respectively injected into the human liquid chromatograph, and the chromatograms are recorded. According to the external standard method to calculate the peak area, that is.
category
sulfonamides.
storage
light shielding, closed storage.
Last Update:2022-01-01 13:43:56
sulfamethoxazole - Compound sulfamethoxazole capsules
Authoritative Data Verified Data
This product contains sulfamethoxazole (C10H11N303S) and trimethoprim (C14H18N403S) should be 90.0% ~ 110.0% of the label amount.
prescription
sulfamethoxazole 200g
Trimethoprim 40g
Appropriate amount of excipients
Made into 1000 tablets
trait
This product is a capsule, the content of white powder.
identification
- an appropriate amount of the contents of the wood sample (equivalent to about 50mg of trimethoprim) was added with 10ml of dilute sulfuric acid, slightly heated to dissolve the trimethoprim, allowed to cool, filtered, and the filtrate was added with iodine test solution 0. 5mu, the formation of brown precipitate.
- take the content of this product (about equivalent to 0.2g of sulfamethoxazole), add 10ml of methanol, shake, filter, take the filtrate as the test solution; in addition, 0.2g of sulfamethoxazole control substance and 40mg of trimethoprim control substance were dissolved in 10ml of methanol as a control solution. According to the thin layer chromatography (General 0502) test, absorb the above two solutions each 5 u1, respectively, on the same silica gel GF254 plate, with chloroform methanol-N,N dimethylformamide (20:2:1) for the development of the agent, expand, dry, set the UV light (254nm) under the view. The position and color of the main spot of the two components shown in the test solution should be the same as the main spot of the control solution.
- in the chromatographic chamber recorded under the content determination item, the retention time of the two main peaks of the test solution should be consistent with the retention time of the corresponding two main peaks of the control solution.
- take an appropriate amount of the content of this product (about 50mg equivalent to sulfamethoxazole) to show the identification reaction of aromatic first amine (General rule 0301).
- two items (2) and (3) can be selected as one item.
examination
- dissolution of this product, according to the dissolution and release determination method (General 0931 first method), with 0.100 ml of 1 mol/L hydrochloric acid solution is the dissolution medium, and the rotation speed is rpm, and the operation is carried out according to law. After 45 minutes, the appropriate amount of the solution is taken, filtered, and 20ul of the filtrate is accurately taken, the dissolution rate of sulfamethoxazole and formazan in each tablet was calculated according to the method under the item of content determination. The limit shall be 70% of the labeled amount and shall be in accordance with the regulations.
- other requirements shall be in accordance with the provisions of the capsule (General rule 0103).
Content determination
- 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-triethylamine (200:799:1)(Adjust the pH value to 5.9 with sodium hydroxide solution or glacial acetic acid) as mobile phase; The detection wavelength is 240mn, and the number of theoretical plates is not less than 4000 based on the peak of methyl chloride, the resolution between sulfamethoxazole peak and trimethoprim peak should meet the requirements.
- determination of contents under the item of loading amount difference, mix well, weigh an appropriate amount (approximately equivalent to 22mg of sulfamethoxazole) accurately, put it in a 100ml bottle, and add O. 1 mol/L hydrochloric acid solution appropriate amount, ultrasonic to dissolve the two main components, with O. Dilute the lmol/L hydrochloric acid solution to the scale, shake well, filter, take the continued filtrate as the test solution, take 20 u1 for precise measurement, inject the human liquid chromatograph, record the chromatogram; take an appropriate amount of sulfamethoxazole and trimethoprim, then add 0.1 mol/L hydrochloric acid solution was dissolved and quantitatively diluted to prepare a solution containing 0.22mg of sulfamethoxazole and 44ug of trimethoprim per 1 ml. According to the external standard method to calculate the peak area, that is.
category
sulfonamides.
storage
light shielding, sealed storage.
Last Update:2022-01-01 13:43:57
sulfamethoxazole - Compound sulfamethoxazole granules
Authoritative Data Verified Data
This product contains sulfamethoxazole (C10H11N303S) and methoxypyramidine (C14mH18N403) should be labeled with the amount of 90.0% ~ 110.0%.
prescription
prescription 1 prescription 2
Sulfamethoxazole 400g 800g
Trimethoprim 80g 160g
Appropriate amount of excipients
Made of 1000 bag
trait
This product is A color or white particles.
identification
- take the fine powder of this product (equivalent to 50mg of trimethoprim), add 10ml of dilute sulfuric acid, heat to dissolve trimethoprim, cool, filter, add 0.5 of Iodine test solution to the filtrate, the formation of brown precipitate.
- take an appropriate amount of fine powder of this product (about 0.2g of sulfamethoxazole), add 10ml of methanol, shake, filter, and take the filtrate as the test solution; in addition, 0.2g of oxazole control substance in sulfanilamide and 40mg of trimethoprim control substance were dissolved in 10ml of methanol as control solution. According to the thin layer chromatography (General 0502) test, Draw 5 u1 of each of the two solutions described in h, respectively point on the same silica gel GF254 thin layer plate, with chloroform-methanol-N,N-dimethylformamide (20:2:1) is a developing solvent, which is developed and examined under a dry set UV lamp (254mn). The position and color of the main spot of the two components shown in the test solution should be the same as the main spot of the control solution.
- in the chromatogram recorded under the content determination item I, the retention time of the two main peaks of the test solution should be consistent with the retention time of the corresponding two main peaks of the control solution.
- take an appropriate amount of this product's fine powder (about 50mg equivalent to sulfamethoxazole) to show the identification reaction of aromatic first amine (General rule 0301).
- two items (2) and (3) above can be selected as one item.
examination
should be consistent with the granules under the relevant provisions (General Principles 0104).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using octa-alkyl silane bonded silica as filler; Acetonitrile-water-triethylamine (200:799:1)(With sodium hydroxide solution or glacial acetic acid to adjust the pH value to 5.9) as mobile phase; The detection wavelength was 240nm. The number of theoretical plates shall not be less than 4000 calculated by trimethoprim peak, and the separation degree between sulfamethoxazole peak and trimethoprim peak shall meet the requirements.
- determination of content under the item of difference in loading amount, mix well, grind finely, weigh a proper amount (about 22mg equivalent to sulfamethoxazole), put it in a 100ml measuring flask, add 0.lmol/L hydrochloric acid solution appropriate amount, ultrasonic to dissolve the two main components, with 0. Dilute the lmol/L hydrochloric acid solution to the scale, shake well, filter, take the continued filtrate as the test solution, take 20 u1 for precise measurement, inject the human liquid chromatograph, record the chromatogram; take an appropriate amount of sulfamethoxazole and trimethoprim, then add 0.1 mol/L hydrochloric acid solution was dissolved and quantitatively diluted to prepare a solution containing 0.22mg of sulfamethoxazole and 44PG of trimethoprim per 1 ml. The solution was shaken and determined by the same method.
category
sulfonamides.
storage
light shielding, sealed storage.
Last Update:2022-01-01 13:43:58
sulfamethoxazole - Pediatric compound sulfamethoxazole tablets
Authoritative Data Verified Data
This product contains sulfamethoxazole (C10H11N303S) should be 95.0% ~ 105.0% of label amount, containing trimethoprim (C14H18N403) should be 90.0% ~ 110.0% of label amount.
prescription
sulfamethoxazole log
Trimethoprim 20g
Appropriate amount of excipients
Made into 1000 tablets
trait
This product is white tablet.
identification
- take an appropriate amount of fine powder of this product (about 50mg of trimethoprim), add 10ml of dilute sulfuric acid, heat to dissolve trimethoprim, cool, filter, add 0.5ml of Iodine test solution to the filtrate, the formation of brown precipitate.
- take an appropriate amount of fine powder of this product (equivalent to 0.2g of sulfamethoxazole), add 10ml of methanol, shake, filter, and take the filtrate as the test solution; in addition, 0.2g of sulfamethoxazole control substance and 40mg of trimethoprim control substance were dissolved in 10ml of methanol and used as a control solution. According to the thin layer chromatography (General 0502) test, absorb the above two solutions each 5 u1, respectively, on the same silica gel GF254 thin layer plate, with chloroform-methanol-N,N-dimethylformamide (20:2:1) was used as a developing solvent, which was developed, dried, and examined under a UV lamp (254mn). The position and color of the main spot of the two components shown in the test solution should be the same as the main spot of the control solution.
- in the chromatogram recorded under the content determination item, the retention time of the two main peaks of the test solution should be consistent with the retention time of the corresponding two main peaks of the control solution.
- take an appropriate amount of fine powder of this product (about 50mg equivalent to sulfamethoxazole) to show the identification reaction of the first aromatic amine (General rule 0301).
- two items (2) and (3) above can be selected as one item.
examination
- dissolution of this product, according to the dissolution and release determination method (General 0931 second method), with 0.500ml of 1 mol/L hydrochloric acid solution is the dissolution medium, and the rotation speed is 75 rpm, and the operation is carried out according to law. After 30 minutes, the appropriate amount of the solution is taken, filtered, and the filtrate is taken as the test solution; take an appropriate amount of sulfamethoxazole control and trimethoprim control, precision weighing, add 0.1 mol/L hydrochloric acid solution is dissolved and quantitatively diluted to prepare a solution containing 0.20mg sulfamethoxazole and 40UG trimethoprim per 1 ml, which is used as a reference solution and determined according to law according to the method under the content determination item, the elution amount of sulfamethoxazole and trimethoprim in each tablet was calculated. The limit shall be 70% of the labeled amount and shall be in accordance with the regulations.
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
- 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-triethylamine (200:799:1)(With sodium hydroxide solution or glacial acetic acid to adjust the pH value to 5.9) as mobile phase; The detection wavelength was 240nm. The number of theoretical plates shall not be less than 4000 calculated by trimethoprim peak, and the separation degree between sulfamethoxazole peak and trimethoprim peak shall meet the requirements.
- determination of 10 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (equivalent to 44mg of sulfamethoxazole), put in a 100ml measuring flask, add 0. lmol/L hydrochloric acid solution appropriate amount, ultrasonic to dissolve the two main components, with 0. Dilute 1 mol/L hydrochloric acid solution to the scale, shake, filter, take the filtrate as the test solution, take 10 u1 with precision, inject human liquid chromatograph, record the chromatogram; additional sulfamethoxazole control and trimethoprim control in appropriate amounts, precision weighing, plus O. 1 mol/L hydrochloric acid solution was dissolved and quantitatively diluted to prepare a solution containing 0.44mg of sulfamethoxazole and 89ug of trimethoprim in 1 ml of solution. According to the external standard method to calculate the peak area, that is.
category
sulfonamides.
storage
light shielding, sealed storage.
Last Update:2022-01-01 13:43:59
sulfamethoxazole - Pediatric compound sulfamethoxazole granules
Authoritative Data Verified Data
This product contains sulfamethoxazole (C10H11N303S) should be 95.0% ~ 105.0% of label amount, containing trimethoprim (C14H18N403) should be 90.0% ~ 110.0% of label amount.
prescription
sulfamethoxazole 100g
Trimethoprim 20g
Appropriate amount of excipients
Made of 1000 bag
trait
This product is white or white particles.
identification
- take an appropriate amount of the fine powder of this product (about 50mg equivalent to trimethoprim), add 10ml of dilute sulfuric acid, slightly heat to dissolve trimethoprim, let it cool, filter, add 0.5ml of Iodine test solution to the filtrate, and form brown precipitate.
- take an appropriate amount of fine powder of this product (equivalent to 0.2g of sulfamethoxazole), add 10ml of methanol, shake, filter, and take the filtrate as the test solution; in addition, 0.2g of sulfamethoxazole control substance and 40mg of trimethoprim control substance were dissolved in 10ml of methanol and used as a control solution. According to the thin layer chromatography (General 0502) test, absorb the above two solutions each 5ul, respectively, on the same silica gel thin layer plate, with chloroform-methanol Dimethyl Formamide (20:2:1) for the development of the solvent, expand, dry, set the UV light (254nm) under the view. The position and color of the main spot of the two components shown in the test solution should be the same as the main spot of the control solution.
- in the chromatogram recorded under the content determination item, the retention time of the two main peaks of the test solution should be consistent with the retention time of the corresponding two main peaks of the control solution.
- take an appropriate amount of the fine powder of this product (about 50mg equivalent to sulfamethoxazole) to show the identification reaction of the first aromatic amine (General rule 0301).
- two items (2) and (3) above can be selected as one item.
examination
should be consistent with the granules under the relevant provisions (General Principles 0104).
Content determination
- 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-triethylamine (200:799:1)(With sodium hydroxide solution or glacial acetic acid to adjust the pH value to 5.9) as mobile phase; The detection wavelength was 240nm. The number of theoretical plates shall not be less than 4000 calculated by trimethoprim peak, and the separation degree between sulfamethoxazole peak and trimethoprim peak shall meet the requirements.
- determination method: the contents under the item of difference in loading amount were mixed uniformly, ground finely, and then a proper amount (equivalent to 22mg of sulfamethoxazole) was accurately weighed, placed in a 100ml measuring flask, and O was added. lmol/L hydrochloric acid solution appropriate amount, ultrasonic treatment to dissolve the two main components, with 0. Dilute the lmol/L hydrochloric acid solution to the scale, shake, filter, take the filtrate as the test solution, take 20 u1 with precision, inject the human liquid chromatograph, record the chromatogram; additional sulfamethoxazole control and trimethoprim control in appropriate amounts, precision weighing, plus O. 1 mol/L hydrochloric acid solution was dissolved and quantitatively diluted to prepare a solution containing 0.22mg of sulfamethoxazole and 44ug of trimethoprim per 1 ml. According to the external standard method to calculate the peak area, that is.
category
sulfonamides.
storage
light shielding, sealed storage.
Last Update:2022-01-01 13:44:00