Medical network - on March 3, in accordance with the pharmaceutical administration law of the People's Republic of China and its implementing regulations of the relevant provisions of the stomach-recovering capsule cicc amine O check additional testing method "approved by the state food and drug supervision and administration bureau, are hereby issued.
Notice is hereby given that the.
Attachment: stomach-recovering capsule cicc amine O check additional testing method (201702) BJY
The food and drug supervision bureau
On February 28, 2017
O stomach-recovering capsule cicc amine check additional testing method (201702) BJY
WeikanglingJiaonang stomach-recovering capsule
Auramine O check 】 【 as high performance liquid chromatography determination of general principles of the (0512)
Chromatographic conditions and system suitability test with octadecyl silane bonded silica gel as the filling agent; With acetonitrile - 0.025 mol/L of potassium dihydrogen phosphate solution (containing 0.2% triethylamine, with phosphoric acid to adjust pH value to 3.0) (" 0) as mobile phase; Detection wavelength of 432 nm. Theoretical plate number O deposit amine chromatographic peak of reference substance in the main calculation, should be not less than 2000.
The system be on the waiting list of the reference substance solution auramine O control right amount, and 70% ethanol made from each 1 ml contains 10 (including g solution.
System be on the waiting list of this product of test sample solution content of 2.0 g, add 70% ethanol 20.0 ml, plug, ultrasonic treatment for 20 minutes, put the cold, filtration, quick.
Measurement precision respectively from the reference substance solution and each 10 (including l solution, injection liquid chromatograph, determination, quick.
In the chromatogram of the test results, should not appear the same as the main reference substance chromatography retention time of chromatographic peak. If appear the same retention time of chromatographic peak, compared with diode array detector corresponding chromatographic peak in the 320-500 - nm wavelength range of ultraviolet - visible absorption spectra and absorption spectra should be the same.
Note: if necessary, can use high performance liquid chromatography - mass spectrometry method validation. Suggest using acetonitrile - 0.02 mol/L ammonium acetate solution (" 0) mobile phase system.
Drafting unit: xiamen municipal food and drug quality inspection institute
Review unit: the drug inspection of Beijing
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