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European Pharmacopoeia 6.0¹ØÓÚÈܽâ¶ÈµÄ¹æ¶¨: SOLUBILITY For this test a maximum of 111 mg of substance (for each solvent) and a maximum of 30 ml of each solvent are necessary. Dissolving procedure Shake vigorously for 1 min and place in a constant temperature device, maintained at a temperature of 25.0 ¡À 0.5 ¡ãC for 15 min. If the substance is not completely dissolved, repeat the shaking for 1 min and place the tube in the constant temperature device for 15 min. Method Weigh 100 mg of finely powdered substance (90) (2.9.12) in a stoppered tube (16 mm in internal diameter and 160 mm long), add 0.1 ml of the solvent and proceed as described under Dissolving Procedure. If the substance is completely dissolved, it is very soluble. If the substance is not completely dissolved, add 0.9 ml of the solvent and proceed as described under Dissolving Procedure. If the substance is completely dissolved, it is freely soluble. If the substance is not completely dissolved, add 2.0 ml of the solvent and proceed as described under Dissolving Procedure. If the substance is completely dissolved, it is soluble. If the substance is not completely dissolved, add 7.0 ml of the solvent and proceed as described under Dissolving Procedure. If the substance is completely dissolved, it is sparingly soluble. If the substance is not completely dissolved, weigh 10 mg of finely powdered substance (90) (2.9.12) in a stoppered tube, add 10.0 ml of the solvent and proceed as described under Dissolving Procedure. If the substance is completely dissolved, it is slightly soluble. If the substance is not completely dissolved, weigh 1 mg of finely powdered substance (90) (2.9.12) in a stoppered tube, add 10.0 ml of the solvent and proceed as described under Dissolving Procedure. If the substance is completely dissolved, it is very slightly soluble. ÖйúÒ©µä2005°æ¶þ²¿±ê×¼·²ÀýÖйØÓÚÈܽâ¶ÈµÄ¹æ¶¨: Èܽâ¶ÈÊÇÒ©Æ·µÄÒ»ÖÖÎïÀíÐÔÖÊ¡£¸÷ÕýÎÄÆ·ÖÖÏîÏÂÑ¡ÓõIJ¿·ÖÈܼÁ¼°ÆäÔÚ¸ÃÈܼÁÖеÄÈܽâÐÔÄÜ£¬¿É¹©¾«ÖÆ»òÖÆ±¸ÈÜҺʱ²Î¿¼£»¶ÔÔÚÌØ¶¨ÈܼÁÖеÄÈܽâÐÔÄÜÐè×÷ÖÊÁ¿¿ØÖÆÊ±£¬Ó¦ÔÚ¸ÃÆ·ÖÖ¼ì²éÏîÏÂÁí×÷¾ßÌ广¶¨¡£Ò©Æ·µÄ½üËÆÈܽâ¶ÈÒÔÏÂÁÐÃû´Ê±íʾ£º ¡¡¡¡¡¡¼«Ò×Èܽ⡡¡¡¡¡¡¡ÏµÖ¸ÈÜÖÊ1g(ml)ÄÜÔÚÈܼÁ²»µ½1mlÖÐÈܽ⣻ ¡¡¡¡¡¡Ò×ÈÜ¡¡¡¡¡¡¡¡¡¡¡¡ÏµÖ¸ÈÜÖÊ1g(ml)ÄÜÔÚÈܼÁ1¡«²»µ½10mlÖÐÈܽ⣻ ¡¡¡¡¡¡Èܽ⡡¡¡¡¡¡¡¡¡¡¡ÏµÖ¸ÈÜÖÊ1g(ml)ÄÜÔÚÈܼÁ10¡«²»µ½30mlÖÐÈܽ⣻ ¡¡¡¡¡¡ÂÔÈÜ¡¡¡¡¡¡¡¡¡¡¡¡ÏµÖ¸ÈÜÖÊ1g(ml)ÄÜÔÚÈܼÁ30¡«²»µ½100mlÖÐÈܽ⣻ ¡¡¡¡¡¡Î¢ÈÜ¡¡¡¡¡¡¡¡¡¡¡¡ÏµÖ¸ÈÜÖÊ1g(ml)ÄÜÔÚÈܼÁ100¡«²»µ½1000mlÖÐÈܽâ; ¡¡¡¡¡¡¼«Î¢Èܽ⡡¡¡¡¡¡¡ÏµÖ¸ÈÜÖÊ1g(ml)ÄÜÔÚÈܼÁ1000¡«²»µ½10000mlÖÐÈܽ⣻ ¡¡¡¡¡¡¼¸ºõ²»ÈÜ»ò²»ÈÜ¡¡ÏµÖ¸ÈÜÖÊ1g(ml)ÔÚÈܼÁ10000mlÖв»ÄÜÍêÈ«Èܽ⡣ ÊÔÑé·¨£º³ýÁíÓй涨Í⣬³ÆÈ¡ÑгÉϸ·ÛµÄ¹©ÊÔÆ·»òÁ¿È¡ÒºÌ幩ÊÔÆ·£¬ÖÃÓÚ25¡æ¡À2¡æÒ»¶¨ÈÝÁ¿µÄÈܼÁÖУ¬Ã¿¸ô5·ÖÖÓÇ¿Á¦ÕñÒ¡30ÃëÖÓ£»¹Û²ì30·ÖÖÓÄÚµÄÈܽâÇé¿ö£¬Èç¿´²»¼ûÈÜÖÊ¿ÅÁ£»òÒºµÎʱ£¬¼´ÊÓΪÍêÈ«Èܽ⡣ ËùÒÔÅ·ÖÞÒ©µäsparingly solubleϵָÈÜÖÊ100mgÄÜÔÚÈܼÁ3.0ml¡«10mlÖÐÍêÈ«Èܽ⣬ÊôÓÚÖйúÒ©µä¡°ÂÔÈÜ¡±µÄ·¶Î§£¬µ«²»ÍêÈ«µÈͬÖйúÒ©µäÖеġ°ÂÔÈÜ¡±£¨ÊÔÑé·½·¨ÂÔÓв»Í¬£©¡£ |
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