药物分析精品教学（吉林大学）Somatropin—BP2010.pdfVIP

British Pharmacopoeia Volume I II Monographs: Medicinal and Pharmaceutical Substances Somatropin General Notices (Ph Eur monograph 0951) C990H1528N262O300S7 22,125 12629-01-5 Action and use Growth hormone. Preparation Somatropin Injection Ph Eur DEFINITION Protein having the structure (191 amino-acid residues) of the major component of growth hormone produced by the human pituitary. Content 91.0 per cent to 105.0 per cent (anhydrous substance). By convention, for the purpose of labelling somatropin preparations, 1 mg of anhydrous somatropin (C H N O S ) is equivalent to 3.0 990 1528 262 300 7 IU of biological activity. PRODUCTION Somatropin is produced by a method based on recombinant DNA (rDNA) technology. During the course of product development, it must be demonstrated that the manufacturing process produces a product having a biological activity of not less than 2.5 IU/mg, using a validated bioassay based on growth promotion and approved by the competent authority. Somatropin complies with the following additional requirements. Host-cell-derived proteins The limit is approved by the competent authority. Host-cell- and vector-derived DNA The limit is approved by the competent authority. CHARACTERS Appearance: white or almost white powder. IDENTIFICATION A. Capillary electrophoresis (2.2.47) as described in the test for charged variants with the following modifications. Injection Test solution (b); under pressure or vacuum, using the following sequence: sample injection for at least 3 s then CZE buffer injection for 1 s. Results In the electropherogram obtained, only 1 principal peak, corresponding to somatropin, is detected: no doubling of this peak is observed. B. Examine the chromatograms obtained in the test for related proteins. Results The principal peak in the