Medicinal Polysorbate 80

CP2025 CDE filing A 500g/bottle 25kg/barrel

Medicinal Polysorbide 80 * excipients * injection grade available

Medicinal Polysorbide 80 * excipients * injection grade available

【 Identification 】 (1) Take 5ml of the aqueous solution (l → 20) of this product, add 5ml of the test solution, boil for a few minutes, let cool, acidify with dilute hydrochloric acid, and it will appear milky white and turbid. (2) Take the aqueous solution of this product (1 → 20), add bromine test solution dropwise, and the bromine test solution will fade. (3) Take 6ml of this product, add 4ml of water and mix well to form a gel like substance. (4) Take 10ml of the aqueous solution of this product (1 → 20), add 5ml of cobalt ammonium thiocyanate solution (take 17.4g of ammonium thiocyanate and 2.8g of cobalt nitrate, dissolve in water to make 100ml), mix well, add 5ml, shake and mix, let it stand, and the layer appears blue. [Inspection] Take 0.50g of this product, dissolve it in 10ml of water, and determine the pH value according to the method (General Rule 0631). The pH value should be 5.0-7.5. Take 10ml of this product and compare it with the same volume of control solution (8.0ml of potassium dichromate solution and 0.8ml of cobalt chloride solution for color comparison, add water to 10ml for comparison, and do not make it darker. Ethylene glycol and diethylene glycol: Take about 4g of this product, weigh it accurately, and place it in a 100ml volumetric flask. Precisely add 1.0ml of internal standard solution (take an appropriate amount of 1,3-butanediol and dilute it with anhydrous solution to make a solution containing about 4mg per 1ml), dilute it with anhydrous solution to the mark, shake well, and use it as the test solution; Take appropriate amounts of ethylene glycol and diethylene glycol reference standards, accurately weigh them, and dilute them with anhydrous solution to prepare a solution containing 4mg of ethylene glycol and diethylene glycol per 1ml as a reference standard storage solution; Accurately measure 1.0ml of reference stock solution and 1.0ml of internal standard solution, place them in a 100ml volumetric flask, dilute with anhydrous solution to the mark, shake well, and use as the reference solution. Accurately measure 1.0ml of the reference solution, place it in a 10ml volumetric flask, dilute with anhydrous solution to the mark, shake well, and use as the sensitivity solution. Test according to the gas chromatography method (General Rule 0521). Using 50% phenyl-50% methyl polysiloxane as the fixed solution (30m × 0.53mm, 1.0 μ m), the starting temperature is 40 ℃, and the temperature is raised at a rate of 10 ℃ per minute to 60 ℃. After 5 minutes, the temperature is raised at a rate of 5 ℃ per minute to 110 ℃ for 5 minutes, then at a rate of 15 ℃ per minute to 170 ℃ for 5 minutes, and then at a rate of 35 ℃ per minute to 280 ℃ for 30 minutes (the time can be adjusted according to the residual situation of the sample). The temperature of the injection port is 270 ℃, and the temperature of the hydrogen flame ionization detector is 290 ℃. Accurately measure 1 μ l of sensitivity solution, inject, adjust the detection sensitivity to ensure that the signal-to-noise ratio of the peak height of ethylene glycol and diethylene glycol is greater than 10; Accurately measure 1 μ l of the test solution and 1 μ l of the control solution, inject them separately, and record the chromatogram. According to the internal standard method, the peak area should not exceed 0.01% for both ethylene glycol and diethylene glycol.

（3） Drug registration inspection:

Drug registration inspection and technical review are conducted simultaneously.

After receiving the registration inspection notice and samples, the drug inspection institute shall complete the inspection within 30 days, issue a drug registration inspection report, and submit it to the State Food and Drug Administration, while copying the provincial food and drug supervision and administration department and applicant who notified it of the inspection.

If sample inspection and drug standard review are required, the drug inspection institute shall complete them within 60 days.

（4） Delivery:

After the provincial bureau makes an administrative licensing decision, it shall be published on the provincial bureau's website within 5 days. If the applicant does not receive the approval document within 10 days, the applicant shall be notified by phone.