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The emergence of drug macromolecules obtained through biotechnological processes has led to a set of specialized tests and assays to determine quality, identity, purity, and potency of these articles in addition to the methods traditionally used for other drug products. These specialized tests that are presented below are Amino Acid Analysis, Capillary Electrophoresis, Isoelectric Focusing, Peptide Mapping, Polyacrylamide Gel Electrophoresis, and Total Protein Assay.

Auxiliary Information—
Staff Liaison : Larry N. Callahan, Ph.D., Scientist
Expert Committee : (BBPP05) Biologics and Biotechnology - Proteins and Polysaccharides
USP29–NF24 Page 2858
Pharmacopeial Forum : Volume No. 27(2) Page 2277
Phone Number : 1-301-816-8385