Microcrystalline CelluloseCellulose [9004-34-6].DEFINITIONMicrocrystalline Cellulose is purified, partially depolymerized cellulose prepared by treating alpha cellulose, obtained as a pulp from fibrous plant material, with mineral acids.IDENTIFICATIONA. ProcedureIodinated zinc chloride solution: Dissolve 20 g of zinc chloride and g of potassium iodide in mL of water. Add g of iodine, and shake for 15 min.Sample: 10 mgAnalysis: Place the Sample on a watch glass, and disperse in 2 mL of Iodinated zinc chloride solution.Acceptance criteria: The substance takes on a violet-blue color.氯化锌碘试液：取氯化锌20g、碘化钾，加水。
再加碘，振摇15min。
测定：取本品10mg，置表面皿上，加氯化锌碘试液2ml。
标准规定：应变为蓝紫色。
Change to read:B. ProcedureSample: g of Microcrystalline Cellulose, accurately weighed to mgAnalysis: Transfer the Sample to a 125-mL conical flask. Add mL of water and mL of M cupriethylenediamine hydroxide solution. Immediately purge the solution with nitrogen, insert the stopper, and shake on a wrist-action shaker, or other suitable mechanical shaker, until completely dissolved. Transfer an appropriate volume of the Sample solution to a calibrated number 150 Cannon-Fenske, or equivalent, viscometer. Allow the solution to equilibrate at 25 ± for NLT 5 min. Time the flow between the two marks on the viscometer, and record the flow time, t1, in s.取本品，精密称定，置125mL具塞锥形瓶中，精密加入水25ml，再精密加入1mol/L双氢氧化乙二胺铜溶液25ml，立即通入氮气以排除瓶中空气，密塞，强力振摇，使微晶纤维素溶解；取适量，置25±℃水浴中，约5min后，移至刻度为150的坎农-芬斯克毛细管粘度计或同等的黏度计内（毛细管内径为~，选用适宜粘度计常数K1 ），照黏度测定法，于25±℃水浴中测定。
记录供试品溶液流经黏度计上下两刻度时的时间t1，按下式计算供试品溶液的运动黏度。
Calculate the kinematic viscosity, (KV)1, of the Microcrystalline Cellulose taken:微晶纤维素的运动黏度(KV)1按下式计算：Result = t1 × k1t1 = flow time (s)k1 = viscometer constant (see Viscosity—Capillary Methods 911 (CN1-May-2015) )Obtain the flow time, t2, for M cupriethylenediamine hydroxide solutions using a number 100 Cannon-Fenske, or equivalent, viscometer.用刻度为100的坎农-芬斯克毛细管粘度计或同等的黏度计测定双氢氧化乙二胺铜溶液流经黏度计上下两刻度时的时间t2，按下式计算空白溶液的运动黏度。
Calculate the kinematic viscosity, (KV)2, of the solvent:空白溶液的运动黏度(KV)2按下式计算：Result = t2 × k2t2 = flow time for M cupriethylenediamine hydroxide solutions (s)t2 =双氢氧化乙二胺铜溶液流经黏度计上下两刻度时的时间(s)k2 = viscometer constantk2 =黏度计常数Determine the relative viscosity, ηrel, of the Microcrystalline Cellulose specimen taken:按下式计算微晶纤维素的相对黏度ηrel：Result = (KV)1/(KV)2(KV)1 = = kinematic viscosity of the Microcrystalline Cellulose taken (KV)1 =微晶纤维素的运动黏度(KV)2 = = kinematic viscosity of the solvent(KV)1 =空白溶液的运动黏度Determine the intrinsic viscosity, [η]c, by interpolation, using theIntrinsic Viscosity Table in the Reference Tables section.在附表中查找特性黏数[η]cCalculate the degree of polymerization, P:按下式计算聚合度P：Result = [(95) × [η]c]/{WS × [(100 - %LOD)/100]}[η]c = intrinsic viscosity[η]c = 特性黏数WS = weight of the Microcrystalline Cellulose taken (g)WS = 微晶纤维素质量(g)%LOD = value obtained from the test for Loss on Drying%LOD = 干燥失重值Acceptance criteria: The degree of polymerization is not greater than 350.标准规定：聚合度应不超过350。
IMPURITIESInorganic ImpuritiesResidue on Ignition 281: NMT %本实验依照美国药典炽灼残渣<281>项下方法测定；标准规定：不得过%。
Delete the following:Heavy Metals, Method II 231: NMT 10 ppm(Official 1-Dec-2015)本实验依照美国药典重金属<231>项下方法II测定；(Official1-Dec-2015)标准规定：不得过10 ppmSPECIFIC TESTSMicrobial Enumeration Tests 61 and Tests for Specified Microorganisms 62: The total aerobic microbial count does not exceed 1000 cfu/g, and the total combined molds and yeasts count does not exceed 100 cfu/g. It meets the requirements of the tests for absence of Staphylococcus aureus and Pseudomonas aeruginosa and for the absence of Escherichia coli and Salmonella species.本试验依照美国药典微生物限度检查<61>和指定微生物限度<62>项下方法测定，微生物限度：需氧菌总数不得过1000cfu/g，霉菌和酵母菌总数不得过100cfu/g。
不得检出金黄色葡萄球菌、铜绿假单胞菌、大肠埃希菌和沙门菌。
Conductivity /电导率Sample: 5 g样品：5gAnalysis: Shake the Sample with 40 mL of water for 20 min, and centrifuge. Retain the supernatant for use in the pH test. Using an appropriate conductivity meter that has been standardized with a potassium chloride conductivity calibration standard having a conductivity of 100 μS/cm, measure the conductivity of the supernatantafter a stable reading is obtained, and measure the conductivity of the water used to prepare the test specimen.Acceptance criteria: The conductivity of the supernatant does not exceed the conductivity of the water by more than 75 μS/cm.取本品，加水40ml，振摇20min，离心，取一部分上清液测定PH用。
取合适的电导率仪，用氯化钾溶液标化电导率校正曲线，使电导率为100μS/cm，取上清液，测定电导率，同法测定制备供试品溶液所用水的电导率，两者之差不得过75 μS/cm。