药物分析精品教学（吉林大学）Somatropin—usp32-27.pdfVIP

Somatropin C H N O S 22,125 [12629-01-5]. 990 1528 262 300 7 » Somatropin is a protein hormone consisting of 191 amino acid residues, and its structure corresponds to the major component of the growth hormone extracted from human pituitary glands. It is produced as a lyophilized powder or bulk solution by methods based on recombinant DNA technology. When prepared as a lyophilized powder, it contains not less than 910 µg of somatropin per mg, calculated on the anhydrous basis. When prepared as a bulk solution, it contains not less than 910 µg of somatropin per mg of total protein. The presence of host-cell DNA and host-cell protein impurities in Somatropin is process specific—the limits of these impurities are determined by validated methods. Manufacturers must demonstrate a correlation between the Assay and a validated and approved growth-promotion based bioassay. It may contain excipients. [NOTE—One mg of anhydrous Somatropin is equivalent to 3.0 USP Somatropin Units.] — – – Packaging and storage Preserve in tight containers, and store between 10 and 25 . Labeling— The labeling states that the material is of recombinant DNA origin. USP Reference standards 11 — USP Endotoxin RS. USP Somatropin RS . Identification— A: Proceed as directed in the test for Chromatographic purity, except to prepare a Standard solution by reconstituting a vial of USP Somatropin RS with the Diluent to obtain a solution having a known concentration of about 2.0 mg per mL. Chromatograph the Standard solution and the Test solution as directed for Procedure: the retention time of the somatropin peak in the chromatogram of the Test solution corresponds to that in the chromatogram of the Standard solution. Peptide Mapping Biotechnology-Derived Articles —Tests — B: (see