Transcription of Insulinum humanum - uspbpep.com
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Insulin, human EUROPEAN PHARMACOPOEIA 01/2005:0838 B. Peptide mapping ( ). SELECTIVE CLEAVAGE OF THE PEPTIDE BONDS. INSULIN, HUMAN Test solution. Prepare a mg/ml solution of the substance to be examined in M hydrochloric acid Insulinum humanum and transfer 500 l of this solution to a clean tube. Add ml of HEPES buffer solution pH R and 400 l of a 1 mg/ml solution of Staphylococcus aureus strain V8. protease R. Cap the tube and incubate at 25 C for 6 h. Stop the reaction by adding ml of sulphate buffer solution pH R. Reference solution. Prepare at the same time and in the same manner as for the test solution but using human insulin CRS instead of the substance to be examined. CHROMATOGRAPHIC SEPARATION. Liquid chromatography ( ). Column : size : l = m, = mm, C257H383N65O77S6 Mr 5808 stationary phase : octadecylsilyl silica gel for chromatography R (3 m) with a pore size of 8 nm, DEFINITION temperature : 40 C.
Insulin injection, biphasic EUROPEAN PHARMACOPOEIA 5.0 Test solution. Dissolve 40.0 mg of the substance to be examined in 0.01 M hydrochloric acid and dilute to 10.0 ml withthesamesolvent. Reference solution (a). Dissolve the contents of a vial of
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