欧洲药典 8.8 附录7 Limit Tests (限量检查法).pdfVIP

Status: You are viewing the legally effective version. Appendix VII Limit Tests (No Ph. Eur. method) Nessler Cylinders Where the use of Nessler cylinders is prescribed in a test of the Pharmacopoeia, Nessler cylinders complying with the following requirements should be used. Nessler cylinders comply with British Standard 612:1966 (Specification for Nessler cylinders). They are of clear glass with a nominal capacity of 50 mL; the overall height is about 15 cm, the external height to the 50-mL mark 11.0 to 12.4 cm, the thickness of the wall 1.0 to 1.5 mm and the thickness of the base 1.0 to 3.0 mm. The external heights to the 50-mL mark of cylinders used for a test must not differ by more than 1 mm. Tubes for Comparative Tests (Ph. Eur. method 2.1.5) Tubes used for comparative tests are matched tubes of colourless glass with a uniform internal diameter. The base is transparent and flat. A column of the liquid is examined down the vertical axis of the tube against a white background, or if necessary, against a black background. The examination is carried out in diffused light. It is assumed that tubes with an internal diameter of 16 mm will be used. Tubes with a larger internal diameter may be used instead but the volume of liquid examined must then be increased so that the depth of liquid in the tubes is not less than where the prescribed volume of liquid and tubes 16 mm in internal diameter are used. Limit Test for Aluminium (Ph. Eur. method 2.4.17) Place the prescribed solution in a separating funnel and shake with 2 quantities, each of 20 mL, and then with one 10 mL quantity of a 5 g/L solution of hydroxyquinoline R in chloroform R. Dilute the combined chloroform solutions to 50.0 mL with chloroform R (test solution). Prepare a standard in the same manner usin