《中国药典》2020四部0904可见异物检查法

USP1790（生效时间2021-05）

USP790 VISIBLE PARTICULATES IN INJECTIONS （生效时间2016-05）

EP 2.9.20

PARTICULATE

CONTAMINATION: VISIBLE

PARTICLES （EP11)

EP 5.17.2

RECOMMENDATIONS

ON TESTING OF PARTICULATE

CONTAMINATION: VISIBLE

PARTICLES （EP11））

无色透明容器包装的无色供试品溶液，光照强度1000~1500lx；

透明塑料容器包装、棕色透明容器包装供试品或有色供试品溶液，光照强度2000~3000lx；

混悬型供试品或乳状液，光照强度增加至约4000lx

Recommends light levels NLT 2000~3750 lux at the point of inspection for routine inspection of clear glass containers. Special attention should be given to ensure that inspection is not performed below the lower limit of 2000 lux. Increased light levels are recommended for translucent plastic containers or those made from amber glass, under these circumstances, light level as high as 10000 lux may prove beneficial.

建议在透明玻璃容器的常规检查时，检查点的光照水平为NLT 2000~3750 lux。应特别注意确保检查不会低于2000勒克斯的下限。半透明塑料容器或琥珀色玻璃容器建议增加光照水平，在这种情况下，高达10000勒克斯的光照水平可能是有益的。

Illumination at the inspection point is maintained at a minimum intensity between 2000 and 3750 lux.

检查点的照明保持在2000至3750勒克斯之间的最小强度。

The intensity of illumination at the viewing point is maintained between 2000 lux and 3750 lux, although higher values may be required for coloured glass or plastic containers and for coloured or turbid preparations.

观察点的照明强度保持在 2000 勒克斯和 3750 勒克斯之间，彩色玻璃或塑料容器以及彩色或浑浊制剂可能需要更高的值。

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