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Organic impurities¡ª £¨usp£© 1¡¢pH 7.0 Phosphate buffer¡ª Dissolve 4.54 g of monobasic potassium phosphate in water to make 500 mL of solution. Dissolve 4.73 g of anhydrous dibasic sodium phosphate in water to make 500 mL of solution. Mix 38.9 mL of the monobasic potassium phosphate solution with 61.1 mL of the dibasic sodium phosphate solution. Adjust, if necessary, by the dropwise addition of the dibasic sodium phosphate solution to a pH of 7.0. 2¡¢Standard preparations¡ª Dissolve a suitable quantity of USP Adenine RS, accurately weighed, in hot water, cool, and dilute quantitatively with water to obtain a solution having a known concentration of about 0.19 mg per mL. Pipet 5-mL portions into three 100-mL volumetric flasks, dilute with 0.10 N hydrochloric acid, 0.010 N sodium hydroxide, and pH 7.0 Phosphate buffer, respectively, to volume, and mix. 3¡¢Test preparations¡ª Proceed as directed for Standard preparations, using the specimen in place of the Reference Standard. 4¡¢Procedure¡ª Obtain the UV absorption spectra of the Test preparations and the Standard preparations concomitantly, in 1-cm cells, covering the range between 220 nm and 320 nm, using water as the blank. The respective absorptivities, calculated on the dried basis, at the wavelengths of maximum absorbance, for each pair of corresponding solutions do not differ by more than 2.0%. ÕâÊÇÓлúÔÓÖʵļì²â·½·¨£¬µÚ1¡¢2¡¢3¶ÎÊÇÊÔ¼ÁºÍ¶ÔÕÕÒº¼°¹©ÊÔÆ·ÒºµÄÅäÖÆ£¬±È½ÏÈÝÒ׿´¶®£¬µ«ÊǵÚ4¶Î¾Í¿´ÃÔãÁË£¬²»ÖªµÀÆä²â¶¨µÄÔÀíÊÇʲô£¬ÒÔÏÂΪ×Ô¼º·ÒëµÄÄÚÈÝ£¬²»ÖªµÀ¶Ô·ñ£¬Çë¸÷λսÓÑÖ¸µ¼Ö¸µ¼£¬½âÊÍÒ»ÏÂÆä²â¶¨µÄÔÀí£º ÓлúÔÓÖÊ£¨usp£©£º 1¡¢Ph7.0»º³åÒº£ºÈ¡4.54gÁ×Ëá¶þÇâ¼ØÓÚ500mlË®ÖÐÈܽ⣬ÅäÖÆÁ×Ëá¶þÇâ¼ØÈÜÒº£¬È¡4.73gÎÞË®Á×ËáÇâ¶þÄÆÓÚ500mlË®ÖÐÈܽ⣬ÅäÖÆÁ×ËáÇâ¶þÄÆÈÜÒº¡£È¡ÉÏÊöÁ×Ëá¶þÇâ¼ØÈÜÒº38.9mlºÍÁ×ËáÇâ¶þÄÆÈÜÒº61.1ml»ìºÏ£¬Èç¹ûÓбØÒª£¬ÓÃÁ×ËáÇâ¶þÄÆÈÜÒº½«»ìºÏÒºphµ÷ÕûΪ7.0. 2¡¢¶ÔÕÕÈÜÒº£ºÈ¡ÊÊÁ¿ÏÙàÑßʶÔÕÕÆ·£¬¾«ÃܳÆÖØ£¬ÓëÈÈË®ÖÐÈܽ⣬ÀäÈ´£¬ÓÃË®¶¨ÈÝÅäÖÆ³Éº¬ÏÙàÑßÊ0.19mg/mlµÄÈÜÒº£¬¸÷Á¿È¡5mlÓÚÈý¸ö100mlÁ¿Æ¿ÖУ¬·Ö±ðÓÃ0.10mol/lÑÎËᣬ0.010mol/lÇâÑõ»¯ÄÆ£¬Ph7.0»º³åҺϡÊÍ£¬¶¨ÈÝ¡£ 3¡¢¹©ÊÔÆ·ÈÜÒº£º°´ÕÕ¶ÔÕÕÆ·ÈÜÒºÅäÖÆµÄ·½·¨ÅäÖÆ¹©ÊÔÆ·ÈÜÒº¡£ 4¡¢¼ì²é£º²ÉÓÃ1cm±ÈÉ«Ãó£¬Ê¹ÓÃË®×÷Ϊ¿Õ°×ÈܼÁ£¬ÓÃUV·¨¶ÔÒÔÉ϶ÔÕÕÆ·ºÍ¹©ÊÔÆ·ÈÜÒº¹²6·Ý·Ö±ð½øÐв¨³¤É¨Ã裬²¨³¤·¶Î§Îª220nm~320nm¡£ÒÔÎÞË®Îï¼ÆË㣬ÿ¶Ô¶ÔÓ¦µÄÈÜÒºÔÚ×î´óÎüÊÕ²¨³¤´¦µÄÎüÊÕÂʲîÒì²»µÃ´óÓÚ2.0%¡£ µÚ4¶ÎÕæµÄ²»¶®Æä²â¶¨µÄÔÀí£¬°ï°ïæ½âÊÍһϰ¡£¨ÏÙàÑßÊÃÀ¹úusp±ê×¼¿ÉÔÚÒ©ÎïÔÚÏß²éѯ£© |
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