I think there must be a lot of people are confused and do not understand the difference between purified water and water for injection. Here is the difference between purified water and water for injection that I have compiled for you, for your reference!
The difference between purified water and water for injectionThe difference between purified water and water for injection also lies in the water production process, the preparation process of purified water can be a variety of choices, but the Pharmacopoeia of various countries on the injection of water for injection process are limited conditions, such as the U.S. Pharmacopoeia explicitly stipulates that the process of preparation of water for injection can only be distillation and reverse osmosis, the Chinese Pharmacopoeia stipulates that the production of water for injection process must be distilled. These are countries according to the actual situation in their own countries to ensure the quality of water for injection of the necessary conditions. Existing many people to the water for injection and purified water Huawei equivalent, which is actually a kind of misleading. Purified water can be obtained through ion exchange, reverse osmosis, EDI, ultrafiltration and other treatments. Purity is also very high, but compared with the water for injection is still a very big gap. The main achievements of purified water used in medical treatment are medical equipment cleaning, production of pharmaceuticals, test water and so on. In China purified water as the source water for water for injection, you can see the difference between the two.
Purified water: the electrolytes in the water are almost completely removed, and insoluble colloidal substances and microbial particles in the water, dissolved gases, organics, etc. have also been removed to a very low degree. Purified water is in line with the drinking water standards for the distillation of raw water, ion exchange, reverse osmosis or other suitable methods for pharmaceutical water, does not contain any additives. It can be used as a solvent or test water for the configuration of ordinary pharmaceutical preparations, but it shall not be used for the configuration of injections. Usually, the remaining salt content in the purified water should be controlled at 0.1mg/L or less, and the conductivity should be at 0.1us/cm when the water temperature is 25°C.
Water for injection: the purity of water is similar to that of purified water, and the main difference between purified water and purified water is that the water is free of microorganisms and pyrogenic substances, and it is the purified water obtained by distillation. Requirements at any time to monitor the various preparation links, regular cleaning and disinfection of water for injection preparation and delivery equipment. Generally 80 ℃ above storage, 65 ℃ above heat preservation cycle or 4 ℃ below the aseptic state of storage, and use within 12 hours of preparation. The Chinese Pharmacopoeia provides that: water for injection is water produced by distillation of purified water; it should meet the requirements of bacterial pyrogen test; water for injection must be produced, stored and distributed under conditions that prevent pyrogen generation. The U.S. Pharmacopoeia in the preparation of water for injection there are two methods, namely, distillation and reverse osmosis. Water for injection can be used as a solvent or diluent for the configuration of sterilized preparations such as injections, eye drops, etc.; cleaning of containers for injection. Sterilized water for injection, water for injection according to the injection production process to prepare, is the water for injection by sterilization of water, is sterile, non-pyrogenic water, can be considered a preparation.
Selected principles of pharmaceutical water preparation methods Pharmaceutical water system in addition to controlling chemical indicators and particulate contamination, must effectively deal with and control microbial and bacterial endotoxin contamination. Purified water system can be used reverse osmosis, while the water system for injection is more use of distillation, distilled water machine is often purified water system distribution loop (water loop) in the main water point. From the pharmaceutical water source water selection, the U.S. Pharmacopeia has greater flexibility, according to its provisions, water for injection can be obtained by distillation or reverse osmosis of potable water, and does not require companies to use purified water as a source of water for the preparation of water for injection.
Of course, the U.S. drinking water standards are not the same as those in China. Experts believe that this flexibility in the U.S. Pharmacopeia gives the ? terms? Wide applicability, from its discussion of pharmaceutical water systems, it is the control of water quality is by no means limited to the previous items and indicators, and extends to the design of the system, construction, validation and operation of all aspects of monitoring. Domestic water for injection are distilled, which is certainly related to the current quality of domestic reverse osmosis apparatus. It should be noted that different distilled water machine on the source water requirements are different, different models of distilled water machine, due to performance differences, they can be purified water, deionized water, deep soft water as the source water, respectively, the preparation of water for injection to get in line with the standard.
On the other hand, to meet the drinking water standards of water as a source of water, or to meet the standards of purified water for the preparation of water for injection, does not necessarily ensure that the water to meet the required standards, which is related to the performance of the selected equipment. It should also be noted that the quality of the source water must be monitored, and the point of abstraction should avoid sources of contamination as much as possible.
Water for injection and purified water quality differenceSuch as the U.S. Pharmacopeia in the purified water and water for injection water quality standards to do a comparison, you can see the main difference between the two. Their physical and chemical indicators are the same, but the water for injection of pyrogen and microbial requirements are higher than the purified water, there is a difference in the purity of water.