主题:【讨论】关于USP 修约的问题

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myreebok
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7. TEST RESULTS 7.10. Interpretation of Requirements
Analytical results observed in the laboratory (or calculated from experimental measurements) are compared with stated acceptance criteria to determine whether the article conforms to compendial requirements.

The reportable value, which often is a summary value for several individual determinations, is compared with the acceptance criteria. The reportable value is the end result of a completed measurement procedure, as documented.

Where acceptance criteria are expressed numerically herein through specification of an upper and/or lower limit, permitted values include the specified values themselves, but no values outside the limit(s). Acceptance criteria are considered significant to the last digit shown.

7.10.10. Equivalence Statements in Titrimetric Procedures The directions for titrimetric procedures conclude with a statement of the weight of the analyte that is equivalent to each mL of the standardized titrant. In such an equivalence statement, the number of significant figures in the concentration of the titrant should be understood to correspond to the number of significant figures in the weight of the analyte. Corrections to calculations based on the blank determination are to be made for all titrimetric assays where appropriate (see Titrimetry [img=12,20]mk:@MSITStore:D:\USP32_NF27.chm::/pub/data/images/chars/lang.gif[/img]541[img=12,20]mk:@MSITStore:D:\USP32_NF27.chm::/pub/data/images/chars/rang.gif[/img]).

7.20. Rounding Rules The observed or calculated values shall be rounded off to the number of decimal places that is in agreement with the limit expression. Numbers should not be rounded until the final calculations for the reportable value have been completed. Intermediate calculations (e.g., slope for linearity) may be rounded for reporting purposes, but the original (not rounded) value should be used for any additional required calculations. Acceptance criteria are fixed numbers and are not rounded.When rounding is required, consider only one digit in the decimal place to the right of the last place in the limit expression. If this digit is smaller than 5, it is eliminated and the preceding digit is unchanged. If this digit is equal to or greater than 5, it is eliminated and the preceding digit is increased by 1.

但是下方表格中97.92%修约成97.9%却评价为NO,请问如何解释
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betty0919
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myreebok
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poorlittle
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betty0919
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个人认为:前面都有要求说测量值必须大于或等于98.0%,后面那个值修约后是97.9%,不符合要求。不能为理解为对修约的评价,修约是对的,只是那个值不在要求范围内(大于或等于98.0%)。
该帖子作者被版主 hyheying2积分, 2经验,加分理由:积极参与
myreebok
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汗,我知道了,原来那个conform是指是不是符合limit~我想太多了
Insm_bbaf3fb0
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