USP〈1225〉药典规程的验证(中英文对照)(15)

原料药（或成药）的含量测定：供试浓度的80%到120%。

Determination of an Impurity: from 50% to 120% of the acceptable criterion.

杂质的测定：接受标准的50%到120%。

For Content Uniformity: a minimum of 70% to 130% of the test concentration, unless a wider or more appropriate range based on the nature of the dosage form (e.g., metered-dose inhalers) is justified.

对于内容物的均一性：最少供试浓度的70%到130%，除非由于剂型的特性（例如，定量吸入气雾剂）而支持应用更宽或更适合的范围。

For Dissolution Testing: ±20% over the specified range (e.g., if the acceptance criteria for a controlled-release product cover a region from 20%, after 1 hour, and up to 90%, after 24 hours, the validated range would be 0% to 110% of the label claim)

对于溶出度检测：在规定范围上±20%（例如，如果一个控释产品的接受标准覆盖了从1小时后20%到24小时后最多90%的区域，则验证区域应该为标签声称值的0%到110%）。

ROBUSTNESS耐用性

Definition---- The robustness of an analytical procedure is a measure of its capability to remain unaffected by small but deliberate variations in procedural parameters listed in the procedure documentation and provides an indication of its suitability during normal usage. Robustness may be determined during development of the analytical procedure.

定义---- 分析规程的耐用性是规程文件中列出的操作参数在微小、故意的变更中不受影响的能力的衡量单位，并在日常使用中提供了其适用性的指标。耐用性可以在分析规程的研发中确定。

SYSTEM SUITABILITY系统适用性

If measurements are susceptible to variations in analytical conditions, these should be suitably controlled, or a precautionary statement should be included in the procedure. One consequence of the

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