RT Journal Article
SR Electronic
T1 Validation of a Spectral Method for Quantitative Measurement of Color in Protein Drug Solutions
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2016.006494
DO 10.5731/pdajpst.2016.006494
A1 Yin, Jian
A1 Swartz, Trevor E
A1 Zhang, Jian
A1 Kabakoff, Bruce
A1 Patapoff, Thomas W
A1 Chen, Bartolo
A1 Marhoul, Joseph
A1 Shih, Norman
A1 Rahimi, Kimia
YR 2016
UL http://journal.pda.org/content/early/2016/04/13/pdajpst.2016.006494.abstract
AB A quantitative spectral method has been developed to precisely measure the color of protein solutions. In this method, a spectrophotometer is utilized for capturing the visible absorption spectrum of a protein solution, which can then be converted to color values (L*a*b*) which represent human perception of color in a quantitative three dimensional space. These quantitative values (L*a*b*) allow for calculating the best match of a sample's color to a European Pharmacopeia reference color solution. In order to qualify this instrument and assay for use in clinical quality control, a technical assessment was conducted to evaluate the assay suitability and precision. Setting acceptance criteria for this study required development and implementation of a unique statistical method for assessing precision in 3-dimensionsal space. Different instruments, cuvettes, protein solutions, and analysts were compared in this study. The instrument accuracy, repeatability, and assay precision were determined. The instrument and assay are found suitable for use in assessing color of drug substances and drug products and is comparable to the current European Pharmacopeia visual assessment method.