多西紫杉醇 EP方法.pdfVIP

EUROPEAN PHARMACOPOEIA 7.0 Docetaxel trihydrate TESTS — total : not more than twice the area of the principal peak in Acidity or alkalinity. Dissolve 0.1 g in water R with gentle the chromatogram obtained with the reference solution (b) heating and dilute to 10 mL with the same solvent. Add (1 per cent); 0.1 mL of methyl red solution R and 0.2 mL of 0.01 M sodium — disregard limit : 0.1 times the area of the principal peak hydroxide. The solution is yellow. Add 0.4 mL of 0.01 M in the chromatogram obtained with reference solution (b) hydrochloric acid. The solution is red. (0.05 per cent). Optical rotation (2.2.7): −0.05° to + 0.05°. Heavy metals (2.4.8): maximum 10 ppm. Dissolve 0.50 g in methanol R and dilute to 10.0 mL with the 2.0 g complies with test C. Prepare the reference solution using same solvent. 2 mL of lead standard solution (10 ppm Pb) R. Absorbance (2.2.25): maximum 0.04 at 480 nm. Loss on drying (2.2.32): maximum 0.5 per cent, determined on Dissolve 0.5 g in a mixture of equal volumes of methanol R and 1.000 g by drying in an oven at 105 °C. of water R with heating, if necessary, at 30-35 °C and dilute Sulfated ash (2.4.14): maximum 0.1 per cent, determined on to 25 mL with the same mixture of solvents. Cool quickly. 1.0 g. Examine immediately. Related substances. Liquid chromatography (2.2.29). ASSAY Solvent mixture : mobile phase B, mobile phase A (35:65 V/V). In order to avoid overheating in the reactio