This product is a sterilization solution prepared by oxytetracycline dihydrate and polyethylene glycol 400. Oxytetracycline (C22H24N2O9) should be 90.0%~110.0% of the labeled amount.

【Character】This product is yellow to brown clear liquid.

【Identification】In the chromatogram recorded under the content determination item, the retention time of the main peak of the sample solution should be the same as that of the reference solution.

【Check】pH value should be 8.5-8.9.

Bacterial endotoxin was taken and examined according to law. The content of endotoxin in oxytetracycline per mg should be less than 0.4 EU.

Five to ten bottles of this product were sterilized and filtered by membrane filtration. The filter was first wetted with 0.1% peptone solution (pH 8.5) 100ml, then washed with 500 ml, 100 ml, 100 ml, 100 ml 0.1% peptone solution (pH 8.5) four times respectively, then rinsed with 100 ml, 100 ml, 100 ml 0.1% peptone solution (pH 7.1) three times respectively, and examined according to law for 14 days, the requirements should be met.

Other requirements under injections should be complied with.

【Content determination】Determination by high performance liquid chromatography.

L21 (styrene-divinylbenzene copolymer, diameter 5-10 um) was used as filler in chromatographic conditions and system applicability test; 50 g tert-butanol was taken and placed in a 1000 ml measuring bottle with 200 ml water to dissolve, 60 ml phosphate buffer (pH 7.5), 50 ml tetrabutylammonium sulfate solution and 10 ml EDTA disodium solution were added, diluted to scale with water and shaken as mobile phase; detection wavelength was 254 nm. The temperature is 60 +2 C, the flow rate is 1 ml per minute, and the temperature of the sample condenser is 4 C (if there is a sample condenser). The separation of oxytetracycline and oxytetracycline peaks should not be less than 5.0 by injection liquid chromatography, and the tailing factor of oxytetracycline peaks should not be less than 1.25 by injection liquid chromatography.

Oxytetracycline reference solution was diluted with 0.01 mol/L hydrochloric acid solution to make a solution containing 0.2 mg per ml as a reference solution (the reference solution should be kept at 2-8 C); tetracycline solution was diluted with 0.01 mol/L hydrochloric acid solution to make a solution containing about 0.2 mg per ml, and tetracycline solution and oxytetracycline reference solution 3 ml and 1.5 ml respectively. Mix well, dilute to 25 ml with water, and use it as separation test solution (separation solution should be kept at 2-8 C); take appropriate amount of this product (about 400 mg of oxytetracycline) in a 200 ml measuring bottle, add 0.01 mol/L hydrochloric acid solution to 100 ml, mix well, add 0.10 mol/L hydrochloric acid solution to 10.0 ml, mix evenly, dilute to scale with 0.01 mol/L hydrochloric acid solution, shake well, take 10 ml with precision, and place 100 ml. In the flask, dilute to the scale with 0.01 mol/L hydrochloric acid solution, shake well, and serve as the test solution (the test solution should be kept at 2-8 ~C). The reference solution and the sample solution were precisely measured at 20 ml, respectively, and injected into the liquid chromatograph (when operating at room temperature, the sample solution should be precisely absorbed within 1-2 minutes and injected into the liquid chromatograph). The chromatogram was recorded and calculated according to the peak area of the external standard method.

【Function and Use】It is used to treat infections caused by Gram positive and negative bacteria, mycoplasma, Leptospira, Rickettsia and Chlamydia in beef cattle and pigs.

【Usage and dosage】Intramuscular or subcutaneous injection of 10-20 mg per kg body weight beef cattle Intramuscular injection once per 1kg weight pig 10 to 20mg

【ADRs】Oxytetracycline allergy may occur in some animals.

【Notes】(1) Milking cows are prohibited; (2) Avoid the use of penicillin at the same time; (3) Freezing is prohibited.

【withdrawal period】beef cattle and pigs 28 days

【Specification】(1) 100ml: 20g (2) 250ml: 50g (3) 500ml: 100g

【Storage】Shade, seal, and store in a cool and dry place.

【validity period】3 years

Note:

Phosphate buffer (pH 7.5) 0.33 mol/L potassium hydrogen phosphate solution - 0.33 mol/L sodium dihydrogen phosphate solution (85:15), mixing, if necessary, adjust the pH value to 7.5, that is.

Tetrabutylammonium sulfate solution takes 1 g tetrabutylammonium sulfate, Water 100ml to dissolve, and adjusts the pH value to 7.5 with 1 mol/L sodium hydroxide solution.

EDTA disodium solution takes 0.04g of EDTA disodium, Water 100ml to dissolve, and adjusts pH value to 7.5 with 1mol/L sodium hydroxide solution.

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