happyjyl
第6楼2007/05/31
又是PDF,看着就头大.先翻译一些:
二甘醇及有关物质限度检查(插一句,有关物质是指有机杂质,不是无机杂质)
resolution solution(这个怎么翻译得请教茅茅姐,我在申报资料中翻译为"分离溶液",药监局和药检所都没有提出过质疑.但我心里很没底的,也许他们认为只要能看懂就行了):取二甘醇和美国药典甘油参比标准品适量,精密称定,用水溶解,定量稀释,必要时用水逐级稀释,制成每ml约0.5mg的溶液.
标准溶液-取二甘醇适量,精密称定,用水溶解,定量稀释,必要时逐级稀释,制成每ml约0.05mg的溶液.
待测溶液-取甘油5g,精密称定,置100ml容量瓶中,用水溶解并稀释至刻度.摇匀.
FYI:
中国药典英文版里把取**适量翻译为weigh a quantity of,而且根据上下文的意思,我觉得这里的quantities of是"适量"的意思.
dilute stepwise:逐级稀释.这种用法在微生物检查中用得很多.
何当奇
第7楼2007/06/01
为什么不直接写 精密称定....
用水溶解精密称定的适量二甘醇和美国药典甘油参比标准品,定量稀释,必要时用水逐级稀释, 制成已知浓度为每ml约0.5mg的溶液。
茅茅
第10楼2007/06/01
Limit of diethylene glycol and related compounds—
Resolution solution— Dissolve accurately weighed quantities of diethylene glycol and USP Glycerin RS in water, and dilute quantitatively, and stepwise if necessary, with water to obtain a solution having a known concentration of about 0.5 mg of each per mL.
Standard solution— Dissolve an accurately weighed quantity of diethylene glycol in water, and dilute quantitatively, and stepwise if necessary, with water to obtain a solution having a known concentration of about 0.05 mg per mL.
Test solution— Transfer 5 g of Glycerin, accurately weighed, to a 100-mL volumetric flask, dissolve in and dilute with water to volume, and mix.
Chromatographic system (see Chromatography 621 )—The gas chromatograph is equipped with a flame-ionization detector, a 0.53-mm × 30-m fused-silica analytical column coated with 3.0-µm G43 stationary phase, and an inlet liner having an inverted cup or spiral structure. The chromatograph is programmed as follows. Initially, the column temperature is equilibrated at 100 until the time of injection, is increased at a rate of 7.5 per minute to 220 , and is maintained at 220 for 4 minutes. The injection port temperature is maintained at 220 , and the detector temperature is maintained at 250 . The carrier gas is helium. The split flow ratio is about 10:1, and the linear flow is maintained at about 38 cm per second. Chromatograph the Resolution solution, and record the peak responses as directed for Procedure: the resolution, R, between diethylene glycol and glycerin is not less than 7.0. Chromatograph the Standard solution, and record the peak responses as directed for Procedure: the relative standard deviation for replicate injections is not more than 15%.
Procedure— Separately inject equal volumes (about 0.5 µL) of the Standard solution and the Test solution into the chromatograph, record the chromatograms, and measure the responses for all the peaks. Calculate the percentage of diethylene glycol in the portion of Glycerin taken by the formula:
100(CS / CU)(rU / rS),
in which CS is the concentration, in mg per mL, of diethylene glycol in the Standard solution; CU is the concentration, in mg per mL, of Glycerin in the Test solution; and rU and rS are the peak responses for diethylene glycol obtained from the Test solution and the Standard solution, respectively: not more than 0.1% is found. Calculate the percentage of each other impurity, excluding any solvent peaks, in the portion of Glycerin taken by the formula:
100(ri / rs),
in which ri is the peak response of each individual impurity obtained from the Test solution; and rs is the sum of the responses of all the peaks obtained from the Test solution: not more than 0.1% of any individual impurity, excluding diethylene glycol, is found; and not more than 1.0% of total impurities, including diethylene glycol, is found.