Molecular Formula | C16H18N3NaO4S |
Molar Mass | 371.39 |
Melting Point | 215°C (dec.)(lit.) |
Specific Rotation(α) | +246~+272° |
Water Solubility | Freely soluble in water. Sparingly soluble in acetone |
Solubility | Soluble in water. |
Appearance | powder |
Color | white with slight yellow cast |
BRN | 4119211 |
PH | pH(100g/l, 25℃):8.0~10.0 |
Storage Condition | 2-8°C |
MDL | MFCD00064313 |
Physical and Chemical Properties | Melting Point: 215°C |
Use | Is a semi-synthetic broad-spectrum penicillin, mainly used for penicillin-sensitive Gram-positive cocci, Escherichia coli, Proteus, Salmonella, Shigella and other treatment |
Risk Codes | R42/43 - May cause sensitization by inhalation and skin contact. R36/37/38 - Irritating to eyes, respiratory system and skin. R22 - Harmful if swallowed |
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.) S36 - Wear suitable protective clothing. S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. |
WGK Germany | 2 |
RTECS | XH8400000 |
FLUKA BRAND F CODES | 3-10 |
HS Code | 29419000 |
Toxicity | LD50 oral in rat: > 5314mg/kg |
Reference Show more | 1. Zhang Bo, Fan Chao, Hong Hao, etc. Whole-cell catalytic synthesis of β-alanine by recombinant Escherichia coli [J]. Journal of Dalian Polytechnic University, 2020(2):108-112. 2. Gao Ming-kun, Zhang Zhi, Qian Fang. Toxicity and functional test of mixed bacterial preparation (BMX) and its effect on fattening pigs [J]. Feed Research, 2018, No.485(04):66-71. 3. Xue Mengying, Li Lu, Zhang Huafeng, Liu Ziqi. Seasonal variation of flavonoids, alkaloids and antimicrobial activities of three species of Ceratopogonidae [J]. Grassland Science 2018 35(11):2614-2621. 4. Wu Qin, Xu Ziyang, Liu Liping, etc. Role of gut microbiota in stress-induced hypertension in rats [J]. Biotechnology Bulletin, 2020, v.36;No.331(02):88-95. 5. Dong Bilian, Cai yanqu, Zhu Zhidong, Zhu Shengshan, Zhu Yujia. In vitro and in vivo antibacterial activity of Chinese herbal compound DC against standard Escherichia coli and ESBLs-producing Escherichia coli [J]. Journal of Guangdong Pharmaceutical University, 2020,36(06):809-814. 6. Nianyuan, Deng Yuanyuan, Wei Zhencheng, Zhang Yan, Tang Xiaojun, Li Ping, Zhou Pengfei, Liu Guang, Zhang famous. Expression and enzymatic characteristics of recombinant wheat resting thiol oxidase and its effect on bread quality [J]. Chinese Journal of bioengineering, 2021,37(02):593-603. 7. Zhang Zheng, Ma gengqin, Wang Hongxuan, Hou Wenfu, Zhou Min. Biological characteristics and multi-drug efflux pump expression of drug-resistant Vibrio parahaemolyticus [J]. Modern food science and technology, 2020,36(08):15-22. 8. Zheng Min, Xu Yifan, Chen Yanyan, Zhou Yijing, Zhang Yuheng, Yu xairui, Hong Min. Ganmai dazao decoction combined with fluoxetine improves depressive symptoms in mice with chronic stress by regulating intestinal flora [J]. Journal of Nanjing University of Traditional Chinese Medicine, 2020,36(05):667-674. 9. Zhang, Nan, et al. "alleviates antibiotic-associated diarrhea, modifies intestinal microbiota, and increases the level of short-chain fatty acids in mice." Food Research International 122 (2019): 191-198.https://doi. 10. Zhang, Fangxing, et al. "The Endogenous Alterations of the Gut Microbiota and Feces Metabolites Alleviate Oxidative Damage in the Brain of LanCL1 Knockout Mice." Frontiers in microbiology 11 (2020): 2126.https://doi.org/10.3389/fmicb.2020.557342 11. Raji, P. , et al. "Antibacterial Activity of Alkaloids, Flavonoids, Saponins and Tannins Mediated Green Synthesised Silver Nanoparticles Against Pseudomonas aeruginosa and Bacillus subtilis." Journal of Cluster Science 30.5(2019).DOI: 10.1007/s10876-019-01 12. [IF=6.475] Nan Zhang et al."Chinese yam (Dioscorea opposita Thunb.) alleviates antibiotic-associated diarrhea, modifies intestinal microbiota and increases the level of short-chain fatty acids in mice."Food Res Int. 2019 Aug;122:191 13. [IF=2.847] Feng Wang et al."Design, Overproduction and Purification of the Chimeric Phage Lysin MLTphg Fighting against Staphylococcus aureus."Processes. 2020 Dec;8(12):1587 14. [IF=10.588] Aiyun Guo et al.Prochloraz alone or in combination with nano-CuO promotes the conjugative transfer of antibiotic resistance genes between Escherichia coli in pure water.J Hazard Mater. 2022 Feb;424:127761 |
This product is (2S, 5R,6R)-3, 3-dimethyl-6-[ (sui-2-amino-2-phenylacetylamino]-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-sodium salt of 2-formate. The content of ampicillin (calculated as C16H19N304S) shall not be less than 85.0% calculated as anhydrous.
take this product, precision weighing, with 0.4% potassium hydrogen phthalate solution dissolved and quantitatively diluted to make a solution containing about 0621 mg per 1 ml, according to the law (general), the specific rotation is from +258 ° to +287 °.
take this product, add water to make a solution containing 0.lg per lml, place it at room temperature for 10 minutes, and then measure it according to law (General rule 0631). The pH value should be 8.0~10.0.
take 5 parts of this product, each 0.6g, respectively, after adding water 5ml to dissolve, the solution should be clear and colorless; If it is turbid, compare with No. 1 turbidity standard solution (General rule 0902 first method), shall not be more concentrated; If the color is developed, it shall not be deeper in comparison with the yellow-green No. 5 standard colorimetric solution (General Principles 0901 first method).
take an appropriate amount of this product and weigh it accurately, add mobile phase A to dissolve and quantitatively dilute to prepare A solution containing about 3mg per 1 ml as A test solution, if there are impurity peaks in the chromatogram of the test solution, the ampicillin dimer shall not exceed 4.5% as calculated by the external standard method, the amount of other single impurities shall not exceed 2.0%, and the total amount of other impurities shall not exceed 5.0%.
take about 0.3g of this product, precision weighing, set in the top empty bottle, precision add water 3ml to dissolve, seal, as a test solution; Respectively, precision weighing acetone, ethyl acetate, isopropyl alcohol, methylene chloride, methyl isobutyl ketone, toluene and n-butyl alcohol were Diluted quantitatively with water to prepare acetone 0.5mg, ethyl acetate 0.5mg, isopropyl alcohol 0.5mg, dichloromethane 0.2mg, A mixed solution of methyl isobutyl ketone 0.5mg, toluene 89, and n-butanol 0.5mg was precisely weighed 3ml, placed in a headspace bottle, sealed, and used as a reference solution. According to the test for determination of residual solvents (General rule 0861 second method), the capillary column with Nitro-terephthalic acid-modified polyethylene glycol (or similar polarity) as stationary liquid is used as the chromatographic column, and the initial temperature is 60 ℃, hold for 6 minutes, then raise the temperature to 150°C at a rate of 20°C per minute for 8 minutes; The inlet temperature is 150°C; The detector temperature is 250°C; The equilibrium temperature of the headspace bottle is 80°C, the equilibration time was 30 minutes. The reference solution was injected in the headspace, and the chromatogram was recorded. The peaks were obtained according to the order of acetone, ethyl acetate, isopropanol, dichloromethane, methyl isobutyl ketone, toluene and n-butanol. Then take the sample solution and the reference solution into the headspace, record the chromatogram, and calculate the peak area according to the external standard method, Dichloromethane residues should not exceed 0.2%, acetone, ethyl acetate, isopropanol, methyl isobutyl ketone, toluene and n-butanol residues should be in accordance with the provisions.
take this product, determination according to law (General Principles 0873), not over 0.8%.
take this product, according to the determination of moisture (General 0832 first method 1), the water content shall not exceed 2.0%.
take this product l.O g, inspection according to law (General Principles 0821 second law), containing heavy metals shall not exceed 20 parts per million.
take 5 parts of this product, each 2g, plus particle inspection water dissolution, inspection according to law (General 0904), should comply with the provisions. (For sterile packaging) insoluble particles take 3 parts of this product, and make a solution containing 50mg per lml of water for particle inspection, and check according to law (General rule 0903). In each lg sample, no more than 6000 particles containing lOum or more, and no more than 600 particles containing 25um or more. (For aseptic dispensing)
take this product, check according to law (General 1143), each 1 mg of ampicillin (according to C16H19N304S) in the amount of endotoxin should be less than 0.10EU. (For injection)
take this product, dissolve and dilute with appropriate solvent, after membrane filtration treatment, inspection according to law (General rule 1101), should comply with the provisions. (For aseptic dispensing)
take an appropriate amount of this product, precision weighing, and add the mobile phase A under the item of related substances to dissolve and quantitatively dilute to prepare A solution containing about 1mg of ampicillin (based on C16H19N304S) per 1 ml, as a test solution, ampicillin was measured according to the method described above.
B-lactam antibiotics, penicillins.
sealed and stored in a dry place.
This product is a sterile powder of ampicillin sodium. The content of ampicillin (based on C16H19N304S) shall not be less than 85.0% calculated as anhydrous; The content of ampicillin (based on C16H19N304S) shall be 95.0% ~ 105.0% of the label amount calculated as average loading.
This product is white or off-white powder or crystalline powder.
take this product, according to ampicillin sodium under the identification test, the results of the apparent contrast.
The contents under the item of loading amount difference were obtained by measuring according to the method of ampicillin sodium under the item.
Same as ampicillin sodium.
calculated as C16H19N304S (1)0.5g (2)1.0g(3)2.0g
sealed and stored in a dry place.