Pure Water Equipment Industry Applications – Pharmaceutical Purified Water Quality Standards

Pure Water Equipment Industry Applications – Pharmaceutical Purified Water Quality Standards

Water quality meets the 2000 edition of the Pharmacopoeia standard: Resistivity: ≥0.5 MΩ·cm; Conductivity: ≤2 μS; Ammonia ≤0.3 μg/ml; Nitrate ≤0.06 μg/ml; Heavy metals ≤0.5 μg/ml. Pharmaceutical Pure Water Quality Standard Items: Chinese Pharmacopoeia (2000 Edition); European Pharmacopoeia (2000 Supplement) = 1 * GB3

① United States Pharmacopeia (24th Edition) = 2 * GB3;

② Source: This product is obtained by distillation, ion exchange, reverse osmosis, or other suitable methods. Obtained from drinking water that meets legal standards through distillation, ion exchange, or other suitable methods. Obtained from drinking water that meets the legal requirements of the US Environmental Protection Agency, the European Community, or Japan through suitable methods. Properties: Colorless, clear liquid, odorless, tasteless. Acidity/Alkalinity: pH meets regulations. Ammonia 0.3 μg/ml ---Ammonium compounds, sulfates and calcium salts, nitrites, carbon dioxide, and non-volatile substances comply with regulations.--- ---Nitrates 0.06μg/ml 0.2μg/ml ---Heavy metals 0.5μg/ml 0.1μg/ml ---Aluminum salts---This item needs to be controlled when used in the production of dialysis fluid.---Easily oxidizable substances comply with regulations.---Total organic carbon---0.5mg/L 0.5mg/L Conductivity---4.3μS/cm (20℃) complies with regulations. Bacterial endotoxins---0.25E.U./ml---Sterility test---Complies with regulations (controlled when used in the preparation of sterile preparations). Microbial exceedance correction standard = 3 * GB3;

③100 CFU/ml 100 CFU/ml Note: The United States Pharmacopeia (Chapter 645) has not undergone substantial revisions since its introduction in 1996. However, last year the United States Pharmacopeia (USP) Pharmaceutical Water Expert Committee proposed some amendments to Chapter (645), which were adopted earlier this year. The new amendments took effect on December 1, 2008. USP (645) allows for both online (Phase 1) and offline (Phase 2 and 3) methods for conductivity monitoring.

However, the use of online conductivity (and TOC) monitoring has grown exponentially due to cost savings from real-time monitoring and control. Furthermore, for offline conductivity testing, the negative impact of carbon dioxide on the conductivity of ultrapure water leads to measurements that deviate from the actual water quality. Therefore, USP (645) revised the use of online conductivity testing. The final amendment added a new chapter to specify procedures and limitations for conductivity testing of sterile purified water, sterile bottle wash water, and sterile inhalation water. The restrictions for these waters are: for containers with a capacity of £10 mL, the conductivity should be <25 mS/cm, and for containers with a capacity >10 mL, the conductivity should be <5 mS/cm.