中英文对照版微晶纤维素质量标准

1、题目：微晶纤维素登记号：页数：1/13制定： 审批：颁发部门：质量管理部 年 月 日 年 月 日 年 月 日生效日期： 年 月 日分发部门：标题1.Characters1.性状A.B.正文A white or almost white, fine or granular powder, practically insoluble in water, in acetone, in ethanol, in toluene and in dilute acids and in a 50 g/l solution of sodium hydroxide.白色或几乎白色，细粉或粒状粉末。不溶于水，丙酮，

2、乙醇，甲苯，稀酸和50g/l的氢氧化钠溶液。Reagent:Zinc Chloride Solution, Iodinated：Dissolve 20 g of zinc chloride and 6.5 g of potassium iodide in 10.5 ml of water . Add 0.5 g of iodine and shake for 15 minutes, filtering if necessary.Store protected from light.Method:Place about 10 mg on a watch-glass and disperse in

3、 2 ml of iodinated zinc chloride solution R. The substance becomes violet-blue.Apparatus: capillary viscometerReagent: nitrogen;Cupriethylenediamine Hydroxide Solution ： Use a 1M solution in which the molar ratio of ethylenediamine to copper is 2.00 ± 0.04.Method:题目：微晶纤维素审批： 年 月 日登记号：页数： 2/13标题

4、正文Transfer 1.300 g to a 125 ml conical flask. Add 25.0 ml of water R and 25.0 ml of 1M cupriethylenediamine hydroxide solution. Immediately purge the solution with nitrogen R, insert the stopper and shake until completely dissolved. Transfer 7.0 ml of the solution to a suitable capillary viscometer

5、(). Equilibrate the solution at 25°C ±0.1°C for not less than 5 min. Record the flow time t1 in seconds, between the 2 marks on the viscometer. Calculate the kinematic viscosity 1 of the solution using the formula: t1(k1) where k1 is the viscometer constant.Dilute a suitable volume of

6、 1M cupriethylenediamine hydroxide solution with an equal volume of water R and measure the flow time t2 using a suitable capillary viscometer. Calculate the kinematic viscosity 2 of the solvent using the formula: t2(k2) where k2 is the viscometer constant.Determine the relative viscosityrel of the

7、substance to be examined using the formula: 1/2Determine the intrinsic viscosity c by interpolation, using the Intrinsic Viscosity Table (Table 0316.-1).Calculate the degree of polymerisation P using the formula:where m is the mass in grams, of the substance to be examined and b is the loss on dryin

8、g as a percentage.The degree of polymerisation is not more than 350.题目：微晶纤维素审批： 年 月 日登记号：页数： 3/13标题2.鉴别A：B：正文试剂：经碘处理的氯化锌溶液（将20g的氯化锌和6.5g的碘化钾溶解于10.5ml水中，再加0.5g的碘，振摇15min，如有必要可过滤，避光保存）；方法：取约10mg的供试品于表面玻璃中，用2ml经碘处理的氯化锌溶液，供试品变为紫蓝色。仪器:毛细管粘度计试剂:±0.04）;氮气方法:取供试品于125ml锥形瓶中，加入水和铜乙二胺碱溶液，立即通入氮气，使溶液净化，塞上塞子

9、，振摇使完全溶解。取7.0ml此溶液用合适的毛细管粘度计检查。在不超过5min内使溶液在25°C ±0.1°C平衡。记录粘度计两个刻度之间的流动时间t1，单位s。按下列的公式计算动力粘度1:t1(k1) k1为粘度计常数。取适量1M铜乙二胺碱溶液用等量的水稀释后，用合适的毛细管粘度计测量流动时间t2。计算溶液的动力粘度2:t2(k2) k2为粘度计常数。计算供试品的相对粘度 rel：1/2c照下列公式计算聚合程度: m为供试品的重量，单位g。b为干燥失重的百分比。聚合程度应不大于350。题目：微晶纤维素审批： 年 月 日登记号：页数： 4/13标题3.检查3.1

10、Solubility3.1.1 Apparatus3.1.2 Reagent3.1.3 Method溶解度仪器方法正文a sintered-glass filter (BS porosity No. 3)Copper Tetrammine, Ammoniacal Solution ： Dissolve 34.5 g of copper(II) sulphate in 100 ml of water M ammonia until the precipitateproduced has completely dissolved. Keeping the temperature below 20&

11、#176;, add dropwise 30 ml of 10M sodium hydroxide, shaking continuously. Filter the precipitate through, wash the precipitate with water M ammonia. Filter through a sintered-glass filter and repeat the filtration to reduce the residue to a minimum.Dissolve 50 mg in 10 ml of ammoniacal solution of co

12、pper tetrammine R. It dissolves completely, leaving no residue.垂熔玻璃滤器（英国标准3号孔径）四氨铜氨水溶液（取硫酸铜用100ml水溶解，搅拌，逐滴加入的氨水至产生的沉淀完全溶解。保持温度在20度以下，逐滴加入30ml10M NaOH，不断振摇。用垂熔玻璃滤器（英国标准3号孔径）过滤沉淀物，用水洗涤，直至滤液澄清。向沉淀物加入氨水，搅拌。用垂熔玻璃滤器过滤，重复过滤操作，使残渣的量为最小）；取供试品50mg，用10ml四氨铜氨水溶液溶解。全部溶解，不留残渣。题目：微晶纤维素审批： 年 月 日登记号：页数： 5/13标题3.2 pH

13、 (2.2.3)3.2.1 Apparatus3.2.2 Method3.2 pH3.3 Ether-soluble substances3.3.1 Reagent3.3.2 Method正文PH meterShake 5 g with 40 ml of carbon dioxide-free water R for 20 min andto 7.5.PH计参照B.P.附录（）。取供试品5g加入40ml不含二氧化碳的水，振摇20min，离心分离。澄清液的pH值为。Ether, Peroxide-free ： Shake 1000 ml of ether with 20 ml of a solu

14、tion of 30 g of iron(II) sulphate in 55 ml of water and 3 ml of sulphuric acid. Continue shaking until a small sample no longer produces a blue colour when shaken with an equal volume of a 2% w/v solution of potassium iodide and 0.1 ml of starch mucilage.Starch Mucilage ： Triturate 0.5 g of starch o

15、r soluble starch with 5 ml of water and add, stirring continuously, to sufficient water to produce about 100 ml. Boil for a few minutes, cool and filter.Produces a blue colour with free iodine in the presence of a soluble iodide.It must be recently prepared.Prepare a column using 10.0 g in a tube ab

16、out 20 mm in internal diameter. Pass 50 ml of peroxide-free ether R through 题目：微晶纤维素审批： 年 月 日登记号：页数： 6/13标题醚溶性物质试剂方法3.4 Water-solublesubstances3.4 水溶性物质3.5 Starch3.5.1 Reagent正文 mg (0.05 per cent).不含过氧化物的乙醚：取30g硫酸亚铁用55ml水和3ml浓硫酸溶解，取1000ml乙醚加入20ml上述硫酸亚铁溶液。加入等量的2%w/v KI 溶液和淀粉粘液，振摇，至加入少量样品不产生蓝色。淀粉粘液：取5

17、g淀粉或可溶性淀粉加5ml水研磨，不断搅拌，加水定容至100ml。煮沸几分钟，放冷，过滤。必须新近配制。取供试品加入直径为20mm的柱中，用50ml不含过氧化物的乙醚洗脱，将洗脱液蒸发干燥。残渣重量不超过（0.05%）。Shake 5.0 g with 80 ml of water R for 10 min. Filter with the aid of vacuum into a tared flask. Evaporate to dryness ona water-bath and dry at 100-105°C for 1 h. The residue weighs not

18、more than 12.5 mg (0.25 per cent).取供试品加入80ml水，振摇10min。抽真空，过滤到抽滤瓶中。水浴蒸发至干燥，在100-105°C干燥1小时。残渣重量不超过12.5mg(0.25%)。M iodine：M iodine dissolve 20 g of potassium iodide in the minimum amount of water , add 13 g of iodine, allow to dissolve and add sufficient water to produce 1000 ml. Weaker solutions

19、 should be prepared using proportionately lesser amounts of reagents or by appropriate dilution.题目：微晶纤维素审批： 年 月 日登记号：页数： 7/13标题3.5.2 Method3.5 淀粉3.5.1试剂：3.5.2方法：3.6 Heavy metals (2.4.8)3.6 重金属3.7 Loss on drying (2.2.32)3.7 干燥失重3.8 Sulphated ash (2.4.14)正文To 10 g add 90 ml of water R and boil for 5 m

20、in. Filter whilst hot. Cool and add to the filtrate 0.1 ml of M iodine.No blue colour is produced.0.05M碘试液：取20g碘化钾用最少量水溶解，加入13g碘，溶解，加水定容至1000ml。取供试品10g加入90ml水，煮沸5min。趁热过滤。放冷后向滤液中加入0.1ml0.05M I2。不产生蓝色。2.0 g complies with limit test C for heavy metals (10 ppm). Prepare the standard using 2 ml of lead standard solution (10ppm Pb) R.参照B.P.附录（）。取参照重金属（10ppm)限量试验C。用2ml10ppm铅标准溶液为标准溶液。Not more than 6.0 per cent, determined on 1.0 g by drying in an oven at 100-105°C for 3 h.参照B.P.附录（）取在100-