Somatropin for Injection
» Somatropin for Injection is a sterile, lyophilized mixture of Somatropin with one or more suitable buffering and stabilizing agents. It contains not less than 89.0 percent and not more than 110.0 percent of the amount of somatropin stated on the label. Manufacturers must demonstrate a corrrelation between the assay and a validated and approved growth-promotion based bioassay. [noteOne mg of anhydrous Somatropin is equivalent to 3.0 USP Somatropin Units. ]
Packaging and storage Preserve in tight containers, and store between 2 and 8.
Labeling The labeling states that the material is of recombinant DNA origin.
USP Reference standards 11
USP Endotoxin RS
Identification It meets the requirements for Identification test A under Somatropin.
Bioidentity [noteIf the bulk material used to prepare Somatropin for Injection was tested and meets the requirements, it is not necessary to perform this test. ] It meets the requirements for Bioidentity under Somatropin.
Bacterial endotoxins 85 It contains not more than 20 USP Endotoxin Units per mg of somatropin.
Sterility 71 It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
Chromatographic purity Proceed as directed for the Chromatographic purity test under Somatropin: not more than 12% of total impurities is found.
Limit of high molecular weight proteins Proceed as directed in the test for Limit of high molecular weight proteins under Somatropin, except to use the Assay preparation as the Test solution: not more than 6% of high molecular weight proteins is found.
Phosphate buffer, Mobile phase, Diluent, Resolution solution, Standard preparation, and Chromatographic system Proceed as directed in the Assay under Somatropin.
Assay preparation Dissolve the contents of a suitable number of containers in Diluent to obtain a concentration of 1 mg of somatropin per mL.
Procedure Proceed as directed under Somatropin. Calculate the quantity of somatropin, in mg of somatropin per container, by the formula:
C(V/N)(rU / rS)in which C is the concentration, in mg per mL, of USP Somatropin RS in the Standard preparation; V is the total volume of the Assay preparation; N is the number of containers used to obtain the Assay preparation; and rU and rS are the peak responses of the monomer in the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 4674Pharmacopeial Forum: Volume No. 30(4) Page 1299