Project Description

USA Analytical Chemistry Laboratory needed to do some validation and qualification testing on reagents that are received from outside vendors to confirm that the certificate of analysis that we receive from the manufacturer is accurate. The following reagents we would need tested:

Reagent 1: Citrate Phosphate Dextrose collection bag.
Tests: Sterility, Identification of CPD reagents in bag.

Reagent 2: CryoSure-Dex40.
Tests: Identification of DMSO and Dextran40 (w/v), Pyrogen, Mycoplasma, Sterility, and Endotoxin testing.

Reagent 3: 6% Hetastarch in 0.9% Sodium Chloride Injection
Tests: Identification of reagents used, Sterility, Bacterial Endotoxin testing, pH, viscosity, weight average