USP - Purified Water - 500 mL
Category/Type: Purified Water
Description: USP Purified Water (USP-PW)
Applications: Purified Water is used as an excipient in the production of non-parenteral preparations and in other pharmaceutical applications, such as cleaning of certain equipment’s and non-parenteral product-contact components. Purified Water must meet the requirements for ionic and organic chemical purity and must be protected from microbial contamination. The source or feed water for the production of Purified Water is Drinking Water. It should also be protected from recontamination and microbial proliferation.
Production: Purified water is commonly produced by ion exchange, reverse osmosis (RO), ultrafiltration or electro-deionization processes and distillation.
Quality: This water produced and tested to meet or exceed USP-PW standards, each lot is quality tested for sterility, endotoxin, conductivity, pH and total organic carbon (TOC). This water is manufactured at a cGMP compliant facility, located locally. The facility is registered with the FDA as a medical device manufacturer and is certified to ISO 13485 standards
Product Specifications: TOC < 500 PPB Conductivity @ 25˚C < 1.3 µS /cm Aerobic Bacteria < 100 CFU/ml Endotoxin (EU/ml) N/A