主题：【原创】翻译与改错（一）

Identification—
A: Prepare iodinated zinc chloride solution by dissolving 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. Place about 10 mg of Microcrystalline Cellulose on a watch glass, and disperse in 2 mL of iodinated zinc chloride solution: the substance takes on a violet-blue color.
鉴别：
A: 制备碘化氯化锌溶液：溶解20 g 氯化锌和6.5 g 碘化钾于10.5 mL 水中，加0.5 g碘，振摇15分钟。 将10 mg微晶纤维素放入表面皿并分散在2 mL碘化氯化锌溶液中，溶液显紫兰色.

B: Transfer 1.3 g of Microcrystalline Cellulose, accurately weighed to 0.1 mg, to a 125-mL conical flask. Add 25.0 mL of water and 25.0 mL of 1.0 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 solution to a calibrated number 150 Cannon-Fenske, or equivalent, viscosimeter. Allow the solution to equilibrate at 25 ± 0.1  for not less than 5 minutes. Time the flow between the two marks on the viscosimeter, and record the flow time, t1, in seconds. Calculate the kinematic viscosity, (KV)1, of the Microcrystalline Cellulose taken by the formula:
t1(k1)
in which k1 is the viscosimeter constant (see Viscosity  911 ). Obtain the flow time, t2, for a 0.5 M cupriethylenediamine hydroxide solution using a number 100 Cannon-Fenske, or equivalent, viscosimeter. Calculate the kinematic viscosity, (KV)2, of the solvent by the formula:
t2(k2)
in which k2 is the viscosimeter constant. Determine the relative viscosity,  rel, of the Microcrystalline Cellulose specimen taken by the formula:
(KV)1 / (KV)2
Determine the intrinsic viscosity, [ ]c, by interpolation, using the Intrinsic Viscosity Table in the Reference Tables section. Calculate the degree of polymerization, P, by the formula:
(95)[ ]c /WS[(l00 – %LOD)/100]
in which WS is the weight, in g, of the Microcrystalline Cellulose taken; and %LOD is the value obtained from the test for Loss on drying. The degree of polymerization is not greater than 350.
B: 取微晶纤维素1.3 g，准确称量到 0.1 mg，置于125-mL 锥形瓶中，加 25.0 mL 水和 25.0 mL 1.0 M的氢氧化铜乙二胺溶液。立即通氮气，盖上盖子，用手摇或其它的方式摇动使样品完全溶解，将7.0 mL 上述溶液转到一个已校正过的150号Cannon-Fenske粘度计或类似的粘度计中。在25 ± 0.1°平衡不少于5分钟，让液体流过粘度计上的两记号, 记录时间, t 1 , 单位秒. 按下式计算动力粘度, (KV)1:
t 1 ( k 1 ),
k 1－粘度计常数(see Viscosity <911> ). 记录0.5 M氢氧化铜乙二胺溶液流出100号Cannon-Fenske粘度计或类似粘度计的时间, t 2 . 按下式计算溶剂的动力粘度, (KV)2,:
t 2 ( k 2 ),
k 2 －粘度计常数. 按下式计算样品的相对粘度,  rel,:
(KV)1 / (KV)2.
使用参照表部分的特性粘度表，通过加补法计算特性粘度, [ ]c,. 按下式计算聚合度, P,:
(95)[ ]c / WS [(l00 – %LOD)/100],
WS为所取样品重量, g， %LOD为测得的干燥失重值。聚合度不大于350。

Microbial limits  61 — The total aerobic microbial count does not exceed 1000 cfu per g, the total combined molds and yeasts count does not exceed 100 cfu per g, and it meets the requirements of the tests for absence of Staphylococcus aureus and Pseudomonas aeruginosa and for absence of Escherichia coli and Salmonella species.
微生物限度 <61>： 需氧微生物总数不超过 1000 cfu per g，霉菌和酵母总数不超过100 cfu/g, 无大肠杆菌，绿脓杆菌，金黄色葡萄球菌和沙门氏菌属。

Conductivity— Shake about 5 g with 40 mL of water for 20 minutes, 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 per cm, measure the conductivity of the supernatant after a stable reading is obtained, and measure the conductivity of the water used to prepare the test specimen. The conductivity of the supernatant does not exceed the conductivity of the water by more than 75 µS per cm.
电导率：取5g微晶纤维素，加40mL水，振摇20分钟，离心。一部分上层液留作pH测试。用一个已经用100 µS/cm的标准氯化钾电导率校正液校正过的电导率仪测定上层液的电导率，并测定配制样品的水的电导率。上层液的电导率超出水的电导率不高于75 µS/cm。
The conductivity of the supernatant does not exceed the conductivity of the water by more than 75 µS per cm. 这句话有点费解

pH  791 : between 5.0 and 7.5 in the supernatant obtained in the Conductivity test.
pH <791> : 电导率测试项下，上层液pH值在5.0 至 7.5之间。
Loss on drying  731 — Dry it at 105  for 3 hours: it loses not more than 7.0% of its weight, or some other lower percentage, or is within a percentage range, as specified in the labeling.
干燥失重 <731> —在105°下干燥3 小时: 失重不超过7.0%，或在标签指定的范围内.
Residue on ignition  281 : not more than 0.1%.
炽灼残渣 USP <281> : 不超过 0.1%.

Bulk density— Use a volumeter that has been fitted with a 10-mesh screen. The volumeter is freestanding of the brass or stainless steel cup, which is calibrated to a capacity of 25.0 ± 0.05 mL and has an inside diameter of 30.0 ± 2.0 mm. Weigh the empty cup, position it under the chute, and slowly pour the powder from a height of 5.1 cm (2 inches) above the funnel through the volumeter, at a rate suitable to prevent clogging, until the cup overflows. [NOTE—If excessive clogging of the screen occurs, remove the screen.] Level the excess powder, and weigh the filled cup. Calculate the bulk density by dividing the weight of the powder in the cup by the volume of the cup: the bulk density is within the labeled specification.
堆积密度— 采用带有10目筛的体积计。此体积计为已经过校正的容积为25.0 ± 0.05 mL的铜或不锈钢杯，内径为30.0 ± 2.0 mm。称空杯重，放在斜道下面，将粉末慢慢的从5.1 cm（2英寸）高处通过一个漏斗倒入体积计直到粉末溢出，倾倒速度以防止筛孔堵塞为准， [注意— 如筛孔过度阻塞, 可以去掉筛. ]移去过量的粉末，使粉末表面平整，称此时的杯重。粉重除以杯体积即为堆积密度。堆积密度应在标示范围内。

Particle size distribution— [NOTE—In cases where there are no functionality-related concerns regarding the particle size distribution of the article, this test may be omitted.] Where the labeling states the particle size distribution, determine the particle size distribution as directed in Particle Size Distribution Estimation by Analytical Sieving  786 , or by a suitable validated procedure.
粒径分布<786> — [ 注意— 如产品对粒径分布没有要求, 可以不检此项. ] 如标签上有粒径分布，直接按筛分法测定粒径分布<786>测定粒径分布，或其它经过验证的程序测定。

Water-soluble substances— Shake 5.0 g with about 80 mL of water for 10 minutes, filter with the aid of vacuum through filter paper (Whatman No. 42 or equivalent) into a vacuum flask. Transfer the filtrate to a tared beaker, evaporate to dryness without charring, dry at 105  for 1 hour, cool in a desiccator, and weigh: the difference between the weight of the residue and the weight obtained from a blank determination does not exceed 12.5 mg (0.25%).
水中可溶物—取5.0微晶纤维素，加80mL水，振摇10分钟，通过滤纸真空抽滤到一个真空瓶中，滤纸为Whatman No. 42 或类似滤纸。将滤液转入已称重的烧杯，105°下干燥1小时，在不烧焦的前提下使其蒸发至干，在干燥器中冷却，称重。测得的残渣重量与空白测定中得到的残渣重量之差不超过12.5 mg (0.25%)。

Ether-soluble substances— Place 10.0 g in a chromatographic column having an internal diameter of about 20 mm, and pass 50 mL of peroxide-free ether through the column. Evaporate the eluate to dryness in a previously dried and tared evaporating dish with the aid of a current of air in a fume hood. After all the ether has evaporated, dry the residue at 105  for 30 minutes, cool in a desiccator, and weigh: the difference between the weight of the residue and the weight obtained from a blank determination does not exceed 5.0 mg (0.05%).
乙醚中可溶物— 将本品10.0 g 放入内径约为20 mm的层析柱，将50 mL不含过氧化物的乙醚通过此柱，洗脱液放在已干燥并称重的蒸发皿中，置通风橱中，在流通空气下蒸发至干，残留物在105°干燥30分钟, 在干燥器中冷却, 称重: 测得的残渣重量与空白测定中得到的残渣重量之差不超过5.0 mg (0.05%).
Heavy metals, Method II  231 : 0.001%.
重金属 USP Method II <231> : 0.001%.
Organic volatile impurities, Method IV <467>: meets the requirements.
有机挥发物Method IV <467>：符合要求。

原文由 hyheying 发表:
USP31版微晶纤维素（Microcrystalline Cellulose）的翻译与改错
原文
USP 31 Microcrystalline Cellulose

Microcrystalline Cellulose [9004-34-6].
微晶纤维素[CAS#9004-34-6]
Packaging and storage— Preserve in tight containers.
Labeling— The labeling indicates the nominal loss on drying, bulk density, and degree of polymerization values. Degree of polymerization compliance is determined using Identification test B. Where the particle size distribution is stated in the labeling, proceed as directed under Particle size distribution. The labeling indicates with which technique the particle size distribution was determined if a technique other than analytical sieving was used; and the labeling indicates the d10, d50, and d90 values and the range for each.
包装与贮存：保存在密封容器中。
标签：标签上应指明干燥失重、堆积密度和聚合度的标称值。聚合度采用鉴别测试B测得。标签上指明了粒径分布的，聚合度直接写在粒径分布的下面。如果粒径不是采用筛分法测得的话，标签上需要指明所采用的粒径测试方法，并且需要指明d10, d50, 和 d90值及其各自的范围。

the nominal loss on drying, bulk density, and degree of polymerization values
是仅指干燥失重的标称值吧，如果是三者的话，nominal的位置就不对了，或者nominal values of loss on drying....
如标签知名粒径分布