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Alhydrogel Specifications

BBS Specifications:

Although all the batches are, as a standard, tested for compliance with the EP final product specifications, some customers still prefer the products to be tested for original specifications from before the monograph 1664 was launched. These specifications are referred to as BBS (i.e. Brenntag Biosector Specifications).

The reason being primarily that the BBS protein adsorption test gives a numeric value for the protein adsorption (mg HSA per ml of the product), whereas the EP testing for this parameter is a limit test. A slight premium is charged for BBS testing.

The BBS specifications for the three products in the series of Alhydrogel® ADJUVANTS can be found on the following slide.

Waiver:

Brenntag Biosector / SERGEANT ADJUVANTS guarantees the specifications above under the liability specified in the company’s "General Conditions of Sale and Delivery". However, individual customers may have internal specifications and/or acceptance limits or specifications which may include additional quality parameters reflecting their particular application of the product. Brenntag Biosector / SERGEANT ADJUVANTS does not accept liability for any such additional parameter, nor guarantees any compliance with such, unless previously explicitly agreed in writing between the parties. It is the sole responsibility of the customer to test the product for any such parameter that goes beyond the standard specifications of Brenntag Biosector /SERGEANT ADJUVANTS before adding the ADJUVANT to their vaccine.

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