Product name | Icatibant |
Product No. | 600710 |
Sequence | H-D-Arg-Arg-Pro-Hyp-Gly-Thi-Ser-D-Tic-Oic-Arg-OH |
Appearance | White or off-white powder |
Solubility | Freely soluble in water |
Specific optical rotation | (-46°to -56°) (C=0.5%; 1% acetic acid,anhydrous and acetic acid free subtance) |
Water | ≤8.0% |
HPLC | The principal peak in the chromatogram obtained with the test solution is similar in retention time to principal peak in the chromatogram obtained with the reference solution. |
Amino acid analysis | Arg 2.7-3.3 |
Pro 0.9-1.1 | |
Hyp 0.9-1.1 | |
Gly 0.9-1.1 | |
Thi 0.9-1.1 | |
Ser 0.8-1.0 | |
Tic 0.9-1.1 | |
Oic 0.9-1.1 | |
Related substances | Any impurity: NMT 0.5% Total impurity: NMT 2.0% |
Assay | 95.0%-105.0% (anhydrous and acetic acid free substance) |
Acetate acid | ≤12.0% |
MS | 1304.5 ± 1.0 |
Storage Condition | In an air tight container, protected from light at temperature 2-8℃. |
Application field: Icatibant (trade name Firazyr, alternative name Hoe 140, JE 049) is a peptidomimetic drug consisting of ten amino acids, which is a selective and specific antagonist of bradykinin B2 receptors. It has been approved by the European Commission for the symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults with C1-esterase-inhibitor deficiency.