USP Purified Water

Why Buy USP Purified Water From ReAgent?

ReAgent is a well-established chemical manufacturer with almost 50 years’ experience. We can meet all of your USP purified water requirements. We are accredited to many ISO standards, including the ISO 9001 Quality Management System, which ensures that our products are always manufactured to the highest standards.Customer satisfaction is of prime importance. Contact us today to discuss your technical requirements and for free technical advice, or to discuss your USP purified water needs. Our expert team is on hand to help you before, during and after your purchase.

About USP Purified Water

USP purified water is water prepared from potable water that complies with drinking water regulations. The purifying process removes impurities from potable water using a combination of ion exchange, reverse osmosis, filtration to 0.2 micron and UV treatment.USP Purified Water is a grade of water which meets the requirements of the United States Pharmacopoeia (USP), an internationally-recognised standard whose specification guarantees a certain level of quality. Other internationally-recognised standards include EP (European Pharmacopoeia), BP (British Pharmacopoeia), and JP (Japanese Pharmacopoeia). ReAgent also supplies EP Water .At ReAgent, we have carried out a validation of the purification process to ensure that the water produced meets with the requirements specified by the USP. We also test the purified water on an ongoing basis in order to ensure that the system is continuously producing water that meets the requirements of the USP.

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Properties of USP Purified Water

Grades of water differ slightly, but all water produced to USP standards is low in impurities such as heavy metals, nitrates, chlorides, and sulphates. It will also meet particular conductivity and pH specifications.USP purified water has to comply with the specification as prescribed in the USP Monograph for the specific grade of water supplied.

pH	5.0 to 7.0
Chloride (mg/l)	0.5
Sulfate (mg/l)	1.0
Ammonia (mg/l)	0.03
Calcium (mg/l)	1.0
Carbon Dioxide (mg/l)	5.0
Oxidizable Substances	Pass the USP Permanganate test
Bacteria	Purified Water (CFU/ml) 100, WFI (CFU/100ml) 10, Sterile PW — Pass the USP Sterility test <71>
TOC	500 ppb
Carbon Conductivity	1.3 TS / cm @ 25° 1.1 TS / cm @ 20°
Endotoxin WFI (EU/ml)	0.25

Applications Of USP Purified Water

Different grades of water are suitable for different pharmaceutical purposes. USP purified water is used:

• In the processing, formulation and manufacture of pharmaceutical products
• As active pharmaceutical ingredients (APIs)
• As analytical reagents
• In cleaning applications

Please contact us to ensure that USP purified water is suitable for your intended use. ReAgent also supplies USP Water for Injection.It is important to note that neither USP purified water nor USP water for injection is sterile, and therefore are unsuitable for parenteral use. For parenteral use, USP Sterile Water for Injection is required.

How We Manufacture USP Water

When we manufacture USP water, we use deionised water as a feedstock in a twin pass reverse osmosis (RO) system.RO is a type of ultrafiltration, and once the water is in this system, it’s continuously moving through the ring main and the storage tank. This means that it’s always passing through the RO and then an ultraviolet (UV) sterilisation stage. The water is then bottled, typically in 25L containers and 1,000L IBCs, or used in process. We carry out weekly testing to ensure compliance with the current specifications – and we also do this for our EP purified water.

What Is The Shelf-life For USP Purified Water?

We investigated options available to extend the shelf life for the different grades of the USP purified water that we produce. The shelf life for this type of water is currently 120 days.We now use a specialised treatment during the filling process. This has two benefits:

1. The water is sterilised
2. The packaging is also sterilised

Once the package is sealed, its contents and packaging are free from bacterial contamination.To ensure this process is failsafe, we sent a series of samples away for laboratory testing for microbial contamination (TVC). We have now tested samples up to four months old, and all samples have returned results below the USP WFI limit of 10 cfu/ 100ml.The current shelf life for both our USP and EP purified water is 120 days, and this will increase as we obtain more data.

Supplying USP Purified Water

Reputable USP purified water suppliers should be accredited to certain quality and environmental standards such as ISO 9001 Quality Management System and ISO 14001 Environmental Management System.Such accreditations help to ensure the quality of the product purchased and help to reduce the negative impact on the environment. ReAgent is accredited to these standards and has almost 50 years’ experience in the chemical industry. We are also a certified Investor in People.We welcome audits from existing and new customers on our USP Purified Water and the processes we use. At ReAgent, we test our USP Purified Water in-house, with microbiological testing performed by a third party.