Somatropin

Sample preparation Prepare a 1 mg/mL solution in 12.5 mM ammonium bicarbonate, filter (0.45 pm), inject an aliquot. 

Mobile phase 50 mM pH 6.8 Phosphate buffer containing 300 mM NaCl and 0.05% sodium azide (Caution Sodium azide is carcinogenic, highly toxic, and can form explosive compounds if discharged to the sewer ) 

Kawashige, M. Sendo, T. Otsubo, K. Aoyama, T. Oishi, R. Quality evaluation of commercial lyophilized human growth hormone preparations. Biol.Pharm.BulL, 1995, 18, 1793-1796 

Katakam, M. Bell, L.N. Banga, A.K. Effect of surfactants on the physical stability of recombinant human growth hormone. J.Pharm.Sci., 1995, 84, 713-716 

Mobile phase Gradient. A was 0.1% trifluoroacetic acid in water. B was 0.1% trifluoroacetic acid in MeCN. A B from 54 46 to 43 57 over 22 min. 

Molecular formula C990H1529N263O299S7 Molecular weIgM 22124.12 CAS Registry No 9002-72-6, 12629-01-5 (human) 

Mobile phase Gradient. MeCN l% acetic acid fi om 10 90 to 90 10 over 5 min 

Detector MS, Agilent 1100 MSD, electrospray, positive ion, nebulizer 20psi, capillary 5000 V, dr3dng gas 7 L/min at 350°, voltage applied to capillary 190 V, m/z 1279.2-1359.1 (natural porcine), m/z 1270.5-1349.5 (recombinant porcine) 

Blokland, M.H. Sterk, S.S. van Ginkel, LA. Stephany, R.W. Heck, AJ.R. Analysis for endogenous and recombinant porcine somatotropine in serum, Anal.Chim.Acta, 2003,483, 201-206. 

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Preliminary report on "Collaborative Study on the Proposed International Standard for Somatropin," National Institute for Biological Standards and Control, London, Dec. 21, 1992. 

Therapeutic Function Growth stimulant Chemical Name See under Structural Formula Common Name Somatropin... 

Ovarian enlargement, hemoperitoneum, febrile reactions, multiple pregnancies, hypersensitivity Failure to respond to therapy due to development of antibodies, hypothyroidism, insulin resistance, swelling of the joints, joint and/or muscle pain Same as somatropin... 

These hormones cause few adverse reactions when administered as directed. Antibodies to somatropin may develop in a small number of patients, resulting in a failure to experience response to therapy, namely, failure of the drug to produce growth in the child. Some patients may experience hypothyroidism or insulin resistance Swelling, joint pain, and muscle pain may also occur. 

Baumann, D. E. (1992). Bovine somatropin Review of an emerging animal technology. /. Dairy Sci. 75, 3432-3451. 

Genotropin Somatropin Pharmacia Upjohn Short stature in children due to growth hormone deficiency... 

Humatrope Somatropin Eli Lilly Human growth hormone deficiency in children... 

Serostim Somatropin Serono laboratories AIDS-associated catabolizm/wastic, pediatric HIV failure to thrive... 

Hageman, M. J., Possert, P., Bauer, J. M. Prediction and characterization of the water sorption isotherm for bovine somatropin recombinant. Journal of Agricultural Food Chemistry, 40(2), p. 342-347, 1992. 

Somatropin is a protein having the structure (191 amino acid residues) of the major component of growth hormone produced by the human pituitary. Somatropin is produced by a method based on recombinant DNA technology. Recently the results of a collaborative study between 14 laboratories have been reported, in which a new CE method was compared with the existing test for isoform distribution by isoelectric focusing. The CE method was found to be superior to the method of isoelectric focusing. As a result CE is applied for identification... 

Somatropin Somatropin bulk solution Somatropin for injection Ph.Eur. Identification and related substances Protein na ... 

FIGURE 6 Typical electropherogram of a somatropin sample. (Reprinted with permission from reference 27.)... 

Recently, a CE method was introduced for impurity profiling of the human growth hormone somatropin produced by the recombinant DNA (rDNA) technology. ... 

The EP limits charged variants of somatropin, e.g., deamidated forms, hy a CZE method that is characterized hy an ammonium phosphate buffer at pH 6.0 as an electrolyte, an uncoated fused silica capillary, and a UV detection at 200 nm (see Eigure 4 for robustness see reference 43). 

This is the consequence of the traditional application of CE in the process and product monitoring of rDNA-derived biopharmaceuticals in biotechnological industries. However, related proteins, and dimer and related substances of higher molecular mass of somatropin, and aprotinin are evaluated by means of HPLC and size exclusion chromatography, respectively, by the EP. 

FIGURE 4 Electropherogram of somatropin CRS (A) Electropherogram of the EP reference solution somatropin CRS I.Omg/ml (B) blank. The major peak corresponds to somatropin. The peaks 1—5 correspond to the impurities described by the Ph.Eur. (2) cleaved form (3) Gin-18 somatropin (4) deamidated forms. Temperature 30 C voltage program 0—l7.4kV. For more conditions see text. 

A), 3.8 billion Amgen s white blood cell stimulant, Neupogen (filgrastim), 3.0 billion interferon pia (Avonex for multiple sclerosis), 2.2 billion human growth hormone (HGH), 1.8 billion recombinant hepatitis B vaccine ( 1.0 billion) somatropin (Humatrope and Neutropin), 0.9 billion and cerezyme/ceredase (alglucerase), 0.6 billion. 

The anabolic effects of somatropin are mediated by somatomedins or insulin-like growth factors. Somatropin is a synthetic polypeptide identical to the natural occurring growth hormone which stimulates longitudinal growth. Only preparations made with recombinant DNA technology are used nowadays. They can consist of 191 amino acids as growth hormone itself or 192 amino acids with one extra methionine. Somatropin is employed in the treatment... 

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