Standard of Purified Water For In Vitro Diagnostic Reagents
In past years ,the industry of in vitro diagnostic reagents has developed rapidly.The application of various new technologies and methods has played an important role in disease prediction,prevention,diagnosis,treatment monitoring ,prognosis observation and health status evaluation.As an integral of IVD reagent products or process used in the production process,the quality of purified water directly affects the accuracy of reagent test results .
| 2015 version Chinese Pharmacopeia | 《YY/T1244-2014》 |
Purified Water | Water For Injection | Purified Water For IVD Reagents |
PH | 4.4-7.6 | 5-7 | 4.4-7.6 |
Nitrate | ≤0.0000006% | ≤0.0000006% | ≤0.0000006% |
Nitrite | ≤0.0000002% | ≤0.0000002% | ≤0.0000002% |
Ammonia | ≤0. 00003% | ≤0. 00003% | ≤0. 00003% |
Conductivity（25°C） | 5.1 μs/cm@25°C | 1.3μs/cm@25°C | ≤1 μs/cm |
TOC | ≤0.50mg/l | ≤0.50mg/l | ≤0.5mg/l |
Easily Oxidized | ≤0.16mg/l | ≤0.16mg/l | ≤0.16mg/l |
Non Volatile Matter | ≤10mg/l | ≤10mg/l | ≤10mg/l |
Heavy Metal | ≤0.00001% | ≤0.00001% | ≤0.00001% |
Microbial Limit | ≤100个/ml | ≤10个/ml | ≤50个/ml |
Bacterial Endotoxin | --- | ≤0.25EU/ml | --- |
Common Preparation Methods | RO | The Multi-effect Distiller | RO+EDI |