Many people know that bacterial infections are easy to occur in daily life. In this case, we must choose to use antibacterial antibiotics for treatment. Tylosin fumarate is a white or light yellow powder with a slight odor. It can be soluble in water and has a good bactericidal effect. However, it is easy to find fakes when buying this type of drug on the market. Therefore, people must understand the identification of Tylosin fumarate. 1. Related substances Take this product and add ethanol to make a solution containing 3 mg per 1 ml as the test solution. Accurately measure an appropriate amount and dilute it with ethanol to make a solution containing 0.3 mg per 1 ml as the control solution. According to the thin layer chromatography method (Appendix page 20), 10 μl of each of the two solutions mentioned above were taken and spotted on the same silica gel GF254 thin layer plate, and butyl acetate-methanol-ammonium hydroxide (20:2:0.4) was used as the developing agent. After development, it was dried and examined under ultraviolet light (254 nm). If impurity spots appeared in the test solution, their color should not be darker than that of the spots shown by the control solution. 2. Absorbance: Take this product, weigh it accurately, dissolve it in water and quantitatively dilute it into a solution containing 50 mg per 1 ml. Determine it by spectrophotometry (Appendix page 16). The absorbance at a wavelength of 650 nm should not exceed 0.03, and at a wavelength of 400 nm, the absorbance should not exceed 0.15. 3. Water content: Take this product and determine it according to the moisture determination method (Method 1 on page 36 of the Appendix). The moisture content shall not exceed 1.0%. Take 1.0g of the product as the residue on ignition and inspect it according to the law. The residue left shall not exceed 0.2%. Heavy metals shall be taken from the residues left over from the item of ignition residues and shall be inspected in accordance with the law (Appendix page 34, Method 2). The heavy metal content shall not exceed 10 parts per million. 4. [Content determination] Take about 0.2g of this product, weigh accurately, dissolve it in 20ml of glacial acetic acid, add 1 drop of crystal violet indicator solution, titrate with perchloric acid titrant (0.1mol/L) until the solution turns blue, and correct the titration result with a blank test. Each 1ml of perchloric acid titration solution (0.1mol/L) is equivalent to 60.98mg of C32H51NO8S. |
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