UPDATE (FEB 2015):

Beginning late February 2015, the following changes will be made to our 100mL (P/N W50-100) and 500mL (P/N W50-500) LAL Reagent Water: Container/Closure - The 100mL (P/N W50-100) and 500mL (P/N W50-500) containers will be changed from a glass bottle with a plastic cap to a plastic bottle with a plastic cap. The container/closure is consistent with the packaging used for the 1 liter LAL Reagent Water product (P/N W50-1000). The type of plastic used for the bottles is PETG - a type 1 recyclable plastic. The type of plastic used for the cap is HDPE - a type 2 recyclable plastic. A stability study, on file at the Lonza Walkersville site, was conducted prior to the change to ensure no adverse effect would result from the container/closure change. Positive Product Control (PPC) – Harmonization of the PPC specification across Lonza LAL Reagent Water products will occur. For the W50-100 and W50-500 products, the specification will be tightened from 50-150% to 75-150%.

Product Overview:

Lonza's LAL Reagent Water (LRW) is manufactured at the Walkersville, MD, USA facility and is tested to purity requirements beyond that of Water for Injection (WFI) and most other non-pyrogenic water products. The purified water system used to produce the LAL Reagent Water is routinely monitored and tested to meet all USP requirements for WFI. Lonza LAL Reagent Water is tested to ensure the endotoxin levels are < 0.005 EU/mL, which is fifty times lower than the USP/EP WFI requirement of < 0.250 EU/mL. Additionally, Lonza has a Positive Product Control (PPC) requirement for the LAL Reagent Water of 75-150%, which is more stringent than the 50-200% PPC recovery allowed by the Pharmacopeia. This ensures the absence of any inhibitory or enhancing properties in the LAL Reagent Water. Use Lonza’s LAL Reagent Water for preparation of any control or sample when performing the endotoxin detection test. Lonza’s water is tested to be endotoxin free and compatible with your endotoxin assay. LAL Reagent Water is equivalent to Water for Bacterial Endotoxins Test (BET).