主题：【原创】翻译与改错（三）

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 Escherichia coli.
pH <791>— Mix 1 g of it with 100 mL of water for 5 minutes: the pH of the dispersion is between 5.0 and 7.0.
Loss on drying <731>— Dry it at 105º for 6 hours: it loses not more than 10.0% of its weight.
微生物限度<61>：需氧菌总数不得超过1000 cfu /g，霉菌和酵母菌总数不得超过100 cfu /g，并不得检出大肠埃希菌。
pH <791> ：取交联羧甲基纤维素钠1g，加100mL水混合5分钟，测得pH值应在5.0-7.0之间。
干燥失重<731>：在105°C干燥6小时，所损失的重量不得超过所取重量的10.0%。

Sodium chloride and sodium glycolate—
SODIUM CHLORIDE— Accurately weigh about 5 g of it into a 250-mL beaker, add 50 mL of water and 5 mL of 30 percent hydrogen peroxide, and heat on a steam bath for 20 minutes, stirring occasionally to ensure hydration. Cool, add 100 mL of water and 10 mL of nitric acid, and titrate with 0.05 N silver nitrate VS, determining the endpoint potentiometrically, using a silver-based indicator electrode and a double-junction reference electrode containing 10% potassium nitrate filling solution in the outer jacket and a standard filling solution in the inner jacket, and stirring constantly (see Titrimetry <541>). Calculate the percentage of sodium chloride in the specimen taken by the formula:
584.4VN/[(100 – b)W]
in which V and N represent the volume, in mL, and the normality, respectively, of the silver nitrate; b is the percentage of Loss on drying, determined separately; W is the weight, in g, of the specimen; and 584.4 is the equivalence factor for sodium chloride.
氯化钠—取本品约5g，精密称定，置于250mL烧杯中，加水50mL和30%过氧化氢溶液5mL，在蒸汽浴中加热20分钟，时时振摇使水合完全。冷却后，加水100mL和硝酸10mL，用硝酸银滴定液(0.05mol/L)滴定，用电位滴定法指示终点，采用银基指示电极和一个外部装有10%硝酸钾溶液、内部装有标准溶液的双功能参照电极，滴定过程中不断搅拌。按下式计算氯化钠的百分比：
584.4VN/[(100 – b)W]
V—样品消耗滴定液的体积，mL；
N—硝酸银滴定液的当量浓度；
b—测得的样品干燥失重百分比；
W—样品称样量；g
584.4—氯化钠当量因子。

SODIUM GLYCOLATE— Transfer about 500 mg of it, accurately weighed, into a 100-mL beaker, moisten thoroughly with 5 mL of glacial acetic acid, followed by 5 mL of water, and stir with a glass rod to ensure proper hydration (usually about 15 minutes). Slowly add 50 mL of acetone while stirring, then add 1 g of sodium chloride, and stir for several minutes to ensure complete precipitation of the carboxymethylcellulose. Filter through a soft, open-textured paper, previously wetted with a small amount of acetone, and collect the filtrate in a 100-mL volumetric flask. Use an additional 30 mL of acetone to facilitate the transfer of the solids and to wash the filter cake, then dilute with acetone to volume, and mix.
乙醇酸钠—取本品500mg，精密称定，置于100mL烧杯中，用5mL冰乙酸完全润湿，接着加5mL水，并用玻棒搅拌使水合作用完全（搅拌时间一般为15分钟），边振摇边缓缓加入50mL丙酮，再加入1g氯化钠，振摇几分钟以确保羧甲基纤维素沉淀完全。用已用少量丙酮润湿过的多孔软滤纸过滤，将滤出液转移至100mL量瓶中，再加30mL丙酮以促进固体物的转移并洗涤滤渣，然后用丙酮稀释至刻度，摇匀。
Use an additional 30 mL of acetone to facilitate the transfer of the solids and to wash the filter cake这段话不好译

Prepare a series of standard solutions as follows. Transfer 100 mg of glycolic acid, previously dried in a desiccator at room temperature overnight and accurately weighed, to a 100-mL volumetric flask, dissolve in and dilute with water to volume, and mix. [NOTE—Use this solution within 30 days.] Transfer 1.0-mL, 2.0-mL, 3.0-mL, and 4.0-mL portions of the solution, respectively, to separate 100-mL volumetric flasks; add water to each flask to make 5 mL; add 5 mL of glacial acetic acid; dilute with acetone to volume; and mix.

取置于室温的干燥器中放置过夜的乙二醇酸100mg，精密称定，置于100mL量瓶中，用水溶解并稀释至刻度，混匀。此溶液应在30天内使用。
精密量取上述溶液1.0 mL、2.0 mL、3.0 mL、4.0mL，分别置于100mL量瓶中，加水使每个容量瓶中的体积均为5mL，再加5mL冰乙酸，并用丙酮稀释至刻度，摇匀。

Transfer 2.0 mL of the test solution and 2.0 mL of each standard solution to separate 25-mL volumetric flasks, and prepare a blank flask containing 2.0 mL of a solution containing 5% each of glacial acetic acid and water in acetone. Place the uncovered flasks in a boiling water bath for 20 minutes, accurately timed, to remove the acetone, remove from the bath, and cool. Add to each flask 5.0 mL of 2,7-dihydroxynaphthalene TS, mix, add an additional 15 mL, and again mix. Cover the mouth of each flask with a small piece of aluminum foil. Place the flasks upright in a boiling water bath for 20 minutes, then remove from the bath, cool, dilute with sulfuric acid to volume, and mix.

精密量取供试液2.0mL、各工作标准溶液2.0mL、空白溶液2.0mL（含冰醋酸和水各5%的丙酮溶液），分别置于6个25mL量瓶中，取下瓶塞，在沸水浴中放置20分钟（准确计时），使丙酮挥发。从水浴中取出容量瓶并冷却。在每个容量瓶中加2,7-二羟基萘试液5.0mL，摇匀，再加2,7-二羟基萘试液15mL后摇匀，用一小块铝箔盖住瓶口，将容量瓶垂直放入沸水浴中，放置20分钟。从水浴中取出容量瓶，冷却，用硫酸稀释至刻度，摇匀。

Determine the absorbance of each solution at 540 nm, with a suitable spectrophotometer, against the blank, and prepare a standard curve using the absorbances obtained from the standard solutions. From the standard curve and the absorbance of the test specimen, determine the weight (w), in mg, of glycolic acid in the specimen, and calculate the percentage of sodium glycolate in the specimen taken by the formula:
12.9w/[(100 – b)W]
in which 12.9 is a factor converting glycolic acid to sodium glycolate; b is the percentage of Loss on drying, determined separately; and W is the weight, in g, of the specimen. The sum of the percentages of sodium chloride and sodium glycolate is not more than 0.5%.

用紫外分光光度计在540nm波长处测定各种溶液的吸光度。以空白溶液和各工作标准溶液测得的吸收值及溶液的浓度绘制标准曲线。
通过标准曲线及测得样品的吸收值按下式计算乙醇酸钠的百分含量：
12.9w(100 – b)W
12.9—乙醇酸钠相对于乙醇酸的转换因子；
b—测得样品的干燥失重；
W—称样量；g
氯化钠和乙酸钠百分比的总量不超过0.5%.

Residue on ignition <281.: between 14.0% and 28.0%, calculated on the dried basis, about 1.0 g being used for the test, using sufficient sulfuric acid to moisten the entire residue after the initial charring step, and additional sulfuric acid if an excessive amount of carbonaceous material remains after the initial complete volatilization of white fumes.
Heavy metals, Method II <231>: 0.001%.


炽灼残渣<281>:按干品计算,在14.0%与28.0%之间.取1.0g的样品，使用足够的硫酸使最初的炭化物润湿，如果白色烟雾完全挥发之后仍有过量的碳化物原料,再加硫酸润湿。

重金属,方法II<231>: 0.001%

Degree of substitution— Transfer about 1 g of it, accurately weighed, to a glass-stoppered, 500-mL conical flask, add 300 mL of sodium chloride solution (1 in 10), then add 25.0 mL of 0.1 N sodium hydroxide VS. Inser* the stopper, and allow to stand for 5 minutes with intermittent shaking. Add 5 d-rops of m-cresol purple TS, and from a buret add about 15 mL of 0.1 N hydrochloric acid VS. inser*  the stopper in the flask, and shake. If the solution is violet, add 0.1 N hydrochloric acid VS in 1-mL portions until the solution becomes yellow, shaking after each addition. Titrate with 0.1 N sodium hydroxide VS to a violet endpoint. Calculate the net number of milliequivalents, M, of base required for the neutralization of 1 g of Croscarmellose Sodium, on the dried basis.
Calculate the degree of acid carboxymethyl substitution, A, by the formula:
1150M /(7102 – 412M – 80C)
in which C is the percentage of residue on ignition of the Croscarmellose Sodium as determined in the test for Residue on ignition.
Calculate the degree of sodium carboxymethyl substitution, S, by the formula:
(162 + 58A)C/(7102 – 80C).
The degree of substitution is the sum of A + S. It is between 0.60 and 0.85, calculated on the dried basis.

注意：上面的*代替字母T (我把*改成t还真不行,为什么?)






取本品1g，精密称定，置于一具有玻璃塞的500mL锥形瓶中，加300mL氯化钠溶液(1:10)，25.0mL氢氧化钠滴定液(0.1mol/L)。塞上瓶塞，放置5分钟，时时振摇。加5滴间甲酚紫试液，并用滴定管加约15mL盐酸滴定液(0.1mol/L)。塞上瓶塞，振摇。如果溶液显紫色，可继续加盐酸滴定液(0.1mol/L)，每次1mL，直到溶液变成黄色，每加一次均需振摇。然后用氢氧化钠滴定液(0.1mol/L)滴定至紫色为终点。按干品计算中和1g羧甲基纤维素钠干品所需碱的毫克当量M.按下式计算羧甲基酸的取代度A:
1150M /(7102-412M-80C)
式中C是炽灼残渣项下所测得的交联羧甲基纤维素钠残渣百分比
按下式计算羧甲基钠的取代度S:
(162 + 58A)C/(7102-80C)
羧甲基纤维素钠的取代度为A+S.按干品计算,应该在0.60与0.85之间.

Content of water-soluble material— Disperse about 10 g, accurately weighed, in 800 mL of water, accurately measured, and stir for 1 minute every 10 minutes during the first 30 minutes. Allow to stand for an additional hour, or centrifuge, if necessary. Decant about 200 mL of the aqueous slurry onto a rapid-filtering filter paper in a vacuum filtration funnel, apply vacuum, and collect about 150 mL of the filtrate. Pour the filtrate into a tared 250-mL beaker, weigh accurately, and calculate the weight, in g, of the filtrate, W3, by difference. Concentrate on a hot plate to a small volume, but not to dryness; dry at 105º for 4 hours; again weigh; and calculate the weight, in g, of residue W1, by difference. Calculate the percentage of water-soluble material in the specimen, on the dried basis, taken by the formula:
100W1(800 + W2)/[W2W3(1 – 0.01b)]
in which W2 is the weight, in g, of the specimen taken; and b is the percentage Loss on drying of the specimen taken: not more than 10.0% is found.

水中可溶物含量:取本品10g，精密称定，准确加入800mL水，在30分钟内，每10分钟摇一次，每次摇一分钟，然后再放置1小时，必要时可用离心机离心，轻轻倒出200mL上清液于一真空过滤漏斗上，快速过滤，收集大约150mL的滤液，置于一已知重量的250mL烧杯中，精密称定，计算以g表示的滤液重量(W3),。在一个热的金属盘中浓缩至剩下较少液体,但不要浓缩至干;然后在105℃干燥4小时，再次称重，并计算以g表示的残渣重量(W1)。通过下列公式按干品计算样品中水中可溶物的百分比：
100W1(800 + W2)/[W2W3(1 – 0.01b)]
W2表示所取样品的重量(以克表示);b是所取样品干燥失重的百分比.所得结果应不超过10.0%

Settling volume— To 75 mL of water in a 100-mL graduated cylinder add 1.5 g of it in 0.5-g portions, shaking vigorously after each addition. Add water to make 100 mL, shake again until all of the powder is homogeneously distributed, and allow to stand for 4 hours. Note the volume of the settled mass. It is between 10.0 and 30.0 mL.
Organic volatile impurities, Method IV <467>: meets the requirements.

沉淀体积：在一个装有75mL水的100mL量筒中加1.5g的样品，分三次加入，每次0.5g，每加入一次均需剧烈振摇。然后加水使成100mL，振摇至所有粉末均匀分散，放置4小时，记录沉淀物的体积。应该在10.0与30.0ml之间.

有机挥发杂质,方法IV<467>: 符合要求.