IndraLab
Statements
sparser
"To demonstrate proper verification of the insulin content in drug products, a quantitative analysis was performed on products containing recombinant hI, porcine insulin, and one hI analog, using the corresponding insulin-type-specific USP (USP29-NF24) and EP monographs appropriately validated for quantitation."
sparser
"In an initial screening assessment, all insulin products were tested with the chromatographic procedure described in the RP-HPLC identification method of the USP monograph (USP29-NF24), “Insulin.” Although this chromatographic procedure is only intended for use with human and porcine insulin products, we used this as a rapid preliminary assessment to screen qualitatively for potentially abnormal insulin traces in all products."