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Water for injection prepared by distillation

Publisher: Suzhou Huanke Pharmaceutical Equipment Technology Co., Ltd Time:2023-03-07 15:11:09 Number of clicks:271 Close

The pharmacopoeia standard for endotoxin in water for injection is not higher than 0.25EU/ml, and the level of endotoxin in drinking water is approximately 10-100EU/ml. After the drinking water is purified by the purification machine, Its endotoxin level is approximately 1-10EU/ml, which is equivalent to the traditional pretreatment +RO/EDI purification machine's endotoxin removal capacity of 1-2log. Distillation is divided into three kinds: single effect distillation, multi-effect distillation and hot pressure distillation. At present, single effect distilled water machine has been eliminated because of no energy saving and other reasons. Multi-effect distilled water machine and hot pressure distilled water machine are widely used in industrial pharmaceutical enterprises.、

Under normal circumstances, the endotoxin removal capacity of hot pressure distilled water machine is about 2-3log level, that is to say, there is a certain risk when drinking water is used to prepare water for injection directly. However, when purified water is prepared by hot pressure distilled water mechanism, the endotoxin content is lower than 0.1EU/ml. According to Chinese Pharmacopoeia: Water for injection needs to be purified water prepared by distillation. Therefore, it is completely safe for enterprises to use hot pressing distilled water machine in Chinese pharmaceutical enterprises.