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2019年马会全年资料 溶液澄清度中国药典与欧洲药典

溶液澄清度
中国药典:
附录Ⅸ B澄清度检查法
本法系在室温条件下,将用水稀释**一定浓度的供试品溶液与等量的浊度标
准液分别置于配对的比浊用玻璃管(内径 15~16mm,平底,具塞,以无色、透
明、中性硬质玻璃制成)中,在浊度标准液制备 5 分钟后,在暗室内垂直同置于伞棚灯下,照度为 1000 lx,从水平方向观察、比较;用以检查溶液的澄清度或其浑浊程度。除另有规定外,供试品溶解后应立即检视。
   品种项下规定的“澄清”,系指供试品溶液的澄清度相同于所用溶剂,或未
超过 0.5 号浊度标准液。“几乎澄清”则指供试品溶液的浊度介于 0.5 号** 1 号浊度标准液的浊度之间。
浊度标准贮备液的制备 称取于105℃干燥**恒重的硫酸肼1.00g,置100ml
量瓶中,加水适量使溶解,必要时可在 40℃的水浴中温热溶解,并用水稀释**
刻度,摇匀,放置 4~6 小时;取此溶液与等容量的 10%乌洛托品溶液混合,摇匀,于 25℃避光静置 24 小时,即得。本液置冷处避光保存,可在两个月内使用,用前摇匀。
浊度标准原液的制备 取浊度标准贮备液 15.0ml,置 1000ml 量瓶中,加水
稀释**刻度,摇匀,取适量,置 1cm 吸收池中,照紫外-可见分光光度法(附录Ⅳ A),在 550nm 的波长处测定,其吸光度应在 0.12~0.15 范围内。本液应在 48小时内使用,用前摇匀。
浊度标准液的制备 取浊度标准原液与水,按下表配制,即得。本液应临用
时制备,使用前充分摇匀。
级号 0.5 1 2 3 4
浊度标准原液/ml 2.50 5.0 10.0 30.0 50.0
水/ml 97.50 95.0 90.0 70.0 50.0
 
 
 
 
 
 
欧洲药典:
Clarity and degree of opalescence of liquids
VISUAL METHOD一般方法
Using identical test-tubes of colourless, transparent, neutral glass with a flat base and an internal diameter of 15-25 mm, compare the liquid to be examined with a reference suspension freshly prepared as described below, the depth of the layer being 40 mm. Compare the solutions in diffused daylight 5 min after preparation of the reference suspension, viewing vertically against a black background. The diffusion of light must be such that reference suspension I can readily be distinguished from water R, and that reference suspension II can readily be distinguished from reference suspension I.
在内径15~25mm,平底,无色、透明、中性玻璃管中,加入等量的供试溶液与浊度标准液,使液位的深度都为40mm,按如下所述方法进行比较。浊度标准液制备5分钟后,以色散自然光照射浊度标准溶液和供试溶液,在黑色背景下从垂直方向观察、比较澄清度或浑浊程度。色散自然光必须较容易区分浊度标准溶液Ⅰ与水,浊度标准溶液Ⅱ与浊度标准溶液Ⅰ
A liquid is considered clear if its clarity is the same as that of water R or of the solvent used when examined under the conditions described above, or if its opalescence is not more pronounced than that of reference suspension I.
如果供试溶液的澄清、透明程度与水相同,或者与所用溶剂相同,或者其澄清度不超过Ⅰ号浊度标准溶液,那么可判定该溶液为澄清。
 
Hydrazine sulfate solution. Dissolve 1.0 g of hydrazine sulfate R in water R and dilute to 100.0 mL with the same solvent. Allow to stand for 4-6 h.
硫酸肼溶液:取1.0g硫酸肼溶于水,加水稀释**100.0ml,静置4~6小时。
 
Hexamethylenetetramine solution. In a 100 mL ground-glass-stoppered flask, dissolve 2.5 g of hexamethylenetetramine R in 25.0 mL of water R.
乌洛托品(六亚甲基四胺)溶液 :在100ml容量瓶中,以25.0ml水溶解2.5g乌洛托品。
 
Primary opalescent suspension (formazin suspension).  
To the examethylenetetramine solution in the flask add 25.0 mL of the hydrazine sulfate solution. Mix and allow to stand for 24 h. This suspension is stable for 2 months, provided it is stored in a glass container free from surface defects. The suspension must not adhere to the glass and must be well mixed before use.
浊度标准贮备液:在存放乌洛托品溶液的100ml容量瓶中,加25.0ml的硫酸肼溶液。混合,静置24小时,贮存在无表面要求的玻璃容器中,可在2个月内使用。该浊度液不得黏附玻璃,用前必须充分摇匀。
 
Standard of opalescence. Dilute 15.0 mL of the primary opalescent suspension to 1000.0 mL with water R. This suspension is freshly prepared and may be stored for up to 24 h.
浊度标准原液:取浊度标准贮备液15ml,加水稀释、定容**1000ml。该液临用前制备,**多保存24小时。