纯化水欧洲药典8.0.pdfVIP

EUROPEAN PHARMACOPOEIA 8.0 Water, purified TESTS Starch 0.5 g Nitrates : maximum 0.2 ppm. Dipotassium hydrogen phosphate 0.3 g Place 5 mL in a test-tube immersed in iced water, add 0.4 mL Magnesium sulfate, anhydrous 0.024 g of a 100 g/L solution of potassium chloride R , 0.1 mL of diphenylamine solution R and, dropwise with shaking, 5 mL of Sodium pyruvate 0.3 g nitrogen-free sulfuric acid R. Transfer the tube to a water-bath Agar 15.0 g at 50 °C. After 15 min, any blue colour in the solution is not more intense than that in a reference solution prepared at the Purified water to 1000 mL same time in the same manner using a mixture of 4.5 mL of nitrate-free water R and 0.5 mL of nitrate standard solution Adjust the pH so that after sterilisation it is 7.2 ± 0.2. Sterilise (2 ppm NO3) R . by heating in an autoclave at 121 °C for 15 min. Growth promotion of R2A agar Aluminium (2.4.17): maximum 10 ppb, if intended for use in the manufacture of dialysis solutions. – Preparation of test strains. Use standardised stable Prescribed solution. To 400 mL of the water to be examined suspensions of test strains or prepa