2016 年,USP <661>章经过修订,适用范围更加全面,能够用于验证各种包装材料和包含多种材料的包装系统。 USP的总有机碳(TOC)法规 USP要求对纯化水(Purified Water,PW)和注射用水(Water for Injection,WFI)进行TOC检测,USP <643>章对此有完整的说明。纯化水和注射用水的TOC限值设定为0.5 ppm。 2016年5月1日,US...
In general, you can wait as long as you want – at your risk. But it is advised to test as soon as practical for the following reasons; 1) when stored, the water purity only degrades over time. Since Purified Water, Water for Injection or the sterile waters are of such high purity,...
In general, you can wait as long as you want – at your risk. But it is advised to test as soon as practical for the following reasons; 1) when stored, the water purity only degrades over time. Since Purified Water, Water for Injection or the sterile waters are of such high purity,...
the water purity only degrades overtime. Since Purified Water, Water for Injection orthe sterile waters are of such high purity, the passage of time does not doanything except potentially degrade the sample due to environmental
6. What is the totalorganic carbon (TOC) limit for Purified Water and Water for Injection? 纯化水和注水的有机碳(TOC)总量限值是多少? There is a "targetlimit response" of 500 µg of Carbon/L. The true limit is the response ofthe TOC measurement system to a 500 µg Carbon/L (pre...
This “intended use” minimum quality is sometimes referred to as a “Specification” or “Limit”, and may include limits for conductivity and TOC listed in water monographs, or other specifications required for these waters that have been defined by the user internally. PC指标、“警告”和“...
e.g.waterusedformanylaboratory analyses.MicrobialguidelinesareprovidedundertheinformationalchapterWater forPharmaceuticalPurposes<1231>whereitstatesthattheusershouldestablishin-house specificationsorfitnessforusemicrobiallevelsabovewhichthewaterisunsuitableforuse. 因为这些水有不同用途,而将微生物要求放在各论中会给一些...
water systems should be microbiologi- cally monitored to confirm that they continue to produce water of acceptable quality. “Alert” and “Action Levels” are there- fore necessary for the monitoring and control of the system. An Alert Level constitutes a warning and does not require a cor- ...
6. What is the total organic carbon (TOC) limit forPurified Water and Water for Injection? 纯化水和注射水的总有机碳(TOC)限度是多少? There is a "target limit response" of 500 µgof Carbon/L. The true limit is the response of the TOC measurement system to a500 µg Carbon/L (prepa...
6. What is the total organic carbon (TOC) limit for Purified Water and Water for Injection? There is a 'target limit response' of 500 μg of Carbon/L. The true limit is the response of the TOC measurement system to a 500 μg Carbon/L (prepared from sucrose) solution, Rs, corrected...