The United States Pharmacopeia (USP) has begun distributing a new lot of Reference Standard Endotoxin (RSE). As a result you may notice some changes in the E700 product you purchase from Lonza. In addition to the lot number of the vial being different, you may also notice a change in vial closure. The previous RSE lot was provided in a glass vial which was stoppered and crimped. The new lot is supplied in a glass vial which is stoppered and capped with a white screw cap.
The storage and shipping conditions of the RSE are also changing. Previously E700 was stored and shipped under refrigerated conditions. Following the recommendations made in the study report entitled “Collaborative Study for the Establishment of the WHO 3rd IS for Endotoxin, the Ph. Eur. Endotoxin Standard BRP batch 5 and the USP RS for Endotoxin lot H (BSP111)”, E700 will now be distributed at ambient temperature and stored frozen.
The USP has assigned a “Valid Use Date” to the previous lot of RSE. Lot number G3E069 has been given a date of February 2013. Per the USP, “The last day of the indicated month represents the expiration date for the specified lot (e.g., "F–1 06/02" means lot F–1 was considered official through June 30, 2002).”
|USP REFERENCE STANDARD ENDOTOXIN||E700||EA||SDS|