中英文对照版微晶纤维素质量标准

insert the stopper and shake until completely dissolved. Transfer 7.0 ml of the solution to a suitable capillary viscometer (2.2.9). 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 υ1 of the solution using the formula: t1(k1) where
题目：微晶纤维素
制定： 年 月 分发部门： 标题 1.Characters 1.Characters 审核： 日 正文 年 月 日 审批：
登记号： 年 月 日
页数： 1/13 颁发部门：质量管理部 生效日期： 年 月 日
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.
stirring, add dropwise 13.5M ammonia until the precipitate produced has completely dissolved. Keeping the temperature below 20°, add dropwise 30 ml of 10M sodium hydroxide, shaking continuously. Filter the precipitate through, wash the precipitate with
iodinated zinc chloride solution R. The substance becomes
violet-blue. B. Apparatus: capillary viscometer Reagent: nitrogen; Cupriethylenediamine Hydroxide Solution ： Use a 1M solution in which the molar ratio of ethylenediamine to copper
k1 is the viscometer constant.
Dilute a suitable volume of 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 υ2 of the solvent using the formula: t2(k2) where k2 is the viscometer constant. Determine the relative viscosityηrel of the substance to be examined using the formula: υ1/υ2 Determine the intrinsic viscosity [η]c by interpolation, using the Intrinsic Viscosity Table (Table 0316.-1). Calculate the degree of polymerisation P using the formula:
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 2 ml of
minutes, cool and filter.Produces a blue colour with free iodine in the presence of a prepared. 3.3.2 Method Prepare a column using 10.0 g in a tube about 20 mm in internal diameter. Pass 50 ml of peroxide-free ether soluble iodide.It must be recently
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： 标题 3.Tests 3.检查 3.检查 3.1 Solubility 3.1.1 Apparatus 3.1.2 Reagent 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 and whilst 年 正文 月 日 登记号： 页数： 4/13
3.3 EtherEther-soluble substances 3.3.1 Reagent of a Ether, Peroxide-free ： Shake 1000 ml of eБайду номын сангаасher with 20 ml
solution of 30 g of iron(II) sulphate in 55 ml of water
Dissolve 50 mg in 10 ml of ammoniacal solution of copper
tetrammine R. It dissolves completely, leaving no residue.
3.1 溶解度 3.1.1 仪器 3.1.2 试剂 垂熔玻璃滤器（英国标准3号孔径） 四氨铜氨水溶液（取34.5g硫酸铜用100ml水溶解，搅拌，逐滴加 入13.5M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200ml13.5M 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）； 3.1.3 方法 渣。 取供试品50mg，用10ml四氨铜氨水溶液溶解。全部溶解，不留残
is 2.00 ± 0.04. Method:
题目：微晶纤维素
审批： 标题 年 正文 Transfer 1.300 g to a 125 ml conical flask. Add 25.0 ml of 月 日 登记号： 页数： 2/13
water R and 25.0 ml of 1M cupriethylenediamine hydroxide solution. Immediately purge the solution with nitrogen R,
water until the filtrate is clear and stir
of 13.5M ammonia. Filter through repeat the filtration to reduce
the precipitate with 200 ml a sintered-glass filter and the residue to a minimum. 3.1.3 Method Method
and 3 ml of
sulphuric acid. Continue shaking until a small
produces a blue colour when shaken with an 2% w/v solution of potassium iodide and 0.1
sample no longer equal volume of a ml of starch
mucilage.
Starch Mucilage ： Triturate 0.5 g of starch or soluble
starch with 5 ml of water and add, stirring continuously, to
sufficient water to produce about 100 ml. Boil for a few
where m is the mass in grams, of the substance to be examined and b is the loss on drying as a percentage. The degree of polymerisation is not more than 350.
题目：微晶纤维素
审批： 标题 3.2 pH (2.2.3) 3.2.1 Apparatus 3.2.2 Method PH meter Shake 5 g with 40 ml of carbon dioxide-free water 年 正文 月 日 登记号： 页数： 5/13
R for
20 min and centrifuge. The pH of the supernatant liquid is 5.0 to 7.5. 3.2 pH 3.2.1 仪器 3.2.2 方法 PH计 参照B.P.附录（2.2.3）。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5.0-7.5。