Assessment of pyrogenic contaminations with validated human whole-blood assay
نویسندگان
چکیده
منابع مشابه
Direct enzymatic assay for %HbA1c in human whole blood samples.
OBJECTIVES Development and validation of a direct enzymatic HbA1c assay that utilizes a single channel on chemistry auto-analyzers without the need to run separate glycated hemoglobin and total hemoglobin assays. DESIGN AND METHODS An enzyme based single channel assay was developed to measure %HbA1c in human whole blood samples. The performance characteristics of the Diazyme Direct Enzymatic ...
متن کاملValidated Colorimetric Assay of Clonidine Hydrochloride from Pharmaceutical Preparations
Clonidine hydrochloride is an antihypertensive agent used for migraine prophylaxis, attention deficit hyperactivity disorder, menopausal flushing and Tourette syndrome. The quantity of the active substance in pharmaceutical preparations must be within specific limits, in agreement with the respective label claim. Therefore, the aim of this study was to establish the conditions for two spectroph...
متن کاملValidated Colorimetric Assay of Clonidine Hydrochloride from Pharmaceutical Preparations
Clonidine hydrochloride is an antihypertensive agent used for migraine prophylaxis, attention deficit hyperactivity disorder, menopausal flushing and Tourette syndrome. The quantity of the active substance in pharmaceutical preparations must be within specific limits, in agreement with the respective label claim. Therefore, the aim of this study was to establish the conditions for two spectroph...
متن کاملIn vitro pyrogen test--A new test method for solid medical devices.
Medical devices manufactured for implantation into humans must be free of any contamination with viable bacteria. However, remnants of dead bacteria and bacterial components alone may induce an inflammatory immune response. Pyrogen tests for such inflammatory contaminations are generally performed either by determining the content of lipopolysaccharide in rinsing solutions of batch samples by l...
متن کاملComparative study of rabbit pyrogen test and human whole blood assay on human serum albumin.
A comparative study of rabbit pyrogen test and human whole blood assay was performed on released preparations of human serum albumin. In addition, the samples were spiked with 5 IU/ml (in whole blood 0.5 IU/ml too) and 10 IU endotoxin/ml. The unspiked samples were negative in both assays. The human whole blood test resulted in the same level of security for the products as the rabbit pyrogen te...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: Nature Protocols
سال: 2009
ISSN: 1754-2189,1750-2799
DOI: 10.1038/nprot.2009.159