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We provide following services to help our
customers to fulfill CBER requirements for a “Well Characterized Product”.
Most of the assays we provide are the key parts of ICH Q6B guidelines
for structural characterization and confirmation and physicochemical
properties determination of biological products.
RP-HPLC for Protein Analysis
Based on newly developed reverse phase
separation using high flow rate and Poros column, excellent resolution
was achieved for the separation of degraded products.
-Separation of degraded or clipped product
from the intact product.
-MS identification of impurity peak to
establish the cleavage sites.
-Report the percentages of
degraded product or impurity based on UV chromatogram.
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